Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01651117
• Collaborator: (none)
• Enrollment: 480
• Location: 1
• Arms: 3
• Actual Duration (Months): 73.2
• Patients Per Site Per Month: 6.6

Study Details

Study Description

Brief Summary

The purpose of this study is to test the effectiveness of a peer mentor model in a mixed race population of poorly controlled diabetic Veterans. Also, the study aims to assess the effects of becoming a mentor on those who originally were mentees. It is expected that participants in the peer mentoring arms (Arm 2 and 3) will have improved glucose control regardless of race or ethnicity at the end of the intervention.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Behavioral: Peer Mentoring	N/A

Detailed Description

The primary objectives of this study are: (1) test the long-term effectiveness of a peer mentor model on improving glucose control, blood pressure, LDL levels, diabetes mellitus quality of life, and depression scores in a mixed race population of poorly controlled diabetic Veterans; (2) test the effectiveness of using former peer mentees as peer mentors as a means of creating a self-sustaining program; and (3) and test the effects of becoming a mentor on those who were originally mentees given a growing literature that being a mentor is good for your health. Secondary objectives include: (1) in those randomized to being a mentee, explore mentor characteristics associated with improved HbA1c.

This study will be a prospective randomized controlled trial. Outcomes to be measured include glycosylated hemoglobin, blood pressure, direct LDL, diabetes quality of life and depression.

The trial has two phases. In phase one, patients with poorly controlled diabetes are randomized to usual care or receiving peer mentoring. In phase two, poorly controlled diabetics are randomized to usual care or receiving peer mentoring from former mentees. Former mentees from phase 1 are also randomized such that they will have a 50% chance of becoming a mentor.

Study Design

• Study Type: Interventional
• Actual Enrollment: 480 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control
• Actual Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Mar 21, 2018
• Actual Study Completion Date: Oct 8, 2018

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual Care Enrolled in two different time frames. No interventions will be provided to this arm. They will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).
Experimental: Peer Mentoring Participants in this arm will be mentored for 6 months by a veteran who was once in poor control but is now in good control. They will then be further randomized to either becoming a mentor for 6 months or having no other additional active intervention. All participants in this arm will be evaluated in person at baseline, 6 months, 12 months, and 18 months.	Behavioral: Peer Mentoring; Patients will receive peer mentoring.
Experimental: Peer Mentoring FFM (from former mentee) Participants in this arm will be mentored by the former mentee for 6 months and will be followed in person for an additional 6 months after the completion of the active intervention.	Behavioral: Peer Mentoring; Patients will receive peer mentoring.

Outcome Measures

Primary Outcome Measures

1. Change in Glucose Control (Stage 1: Usual Care v. Peer Mentoring) [Baseline to 6 months]

   Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)

2. Change in Glucose Control (Stage 2: Usual Care v. Mentees) [Baseline to 6 months]

   Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)

3. Change in Glucose Control (Stage 2: Non-mentors v. Mentors) [Baseline to 6 months]

   Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)

Secondary Outcome Measures

1. Change in Direct LDL Blood Levels [Baseline to 6 months]

   Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)

2. Change in Systolic Blood Pressure [Baseline to 6 months]

   Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month BP is lower than the baseline BP. (Change = final measure - initial measure)

3. Change in Diabetes Quality of Life Score [Baseline to 6 months]

   Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)

4. Change in Depression Symptoms [Baseline to 6 months]

   As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)

5. Change in Glucose Control [Baseline to 12 months]

   Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)

6. Change in Direct LDL Blood Levels [Baseline to 12 months]

   Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)

7. Change in Systolic Blood Pressure [Baseline to 12 months]

   Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month BP is lower than the baseline BP. (Change = final measure - initial measure)

8. Change in Diabetes Quality of Life [Baseline to 12 months]

   Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)

9. Change in Depression Symptoms [Baseline to 12 months]

   As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)

10. Change in Direct LDL Blood Levels (Stage 2: Usual Care v. Mentees) [Baseline to 6 months]

    Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)

11. Change in Systolic Blood Pressure (Stage 2: Usual Care v. Mentee) [Baseline to 6 months]

    Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month BP is lower than the baseline BP. (Change = final measure - initial measure)

12. Change in Diabetes Quality of Life (Stage 2: Usual Care v. Mentee) [Baseline to 6 months]

    Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)

13. Change in Depression Symptoms (Stage 2: Usual Care v. Mentees) [Baseline to 6 months]

    As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)

14. Change in Glucose Control (Stage 2: Usual Care v. Mentees) [Baseline to 12 months]

    Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)

15. Change in Direct LDL Blood Levels (Stage 2: Usual Care v. Mentees) [Baseline to 12 months]

    Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)

16. Change in Systolic Blood Pressure (Stage 2: Usual Care v. Mentee) [Baseline to 12 months]

    Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month BP is lower than the baseline BP. (Change = final measure - initial measure)

17. Change in Diabetes Quality of Life (Stage 2: Usual Care v. Mentee) [Baseline to 12 months]

    Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)

18. Change in Depression Symptoms (Stage 2: Usual Care v. Mentees) [Baseline to 12 months]

    As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)

19. Change in Direct LDL Blood Levels (Stage 2: Non-mentors v. Mentors) [Baseline to 6 months]

    Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)

20. Change in Systolic Blood Pressure (Stage 2: Non-mentors v. Mentors) [Baseline to 6 months]

    Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month BP is lower than the baseline BP. (Change = final measure - initial measure)

21. Change in Diabetes Quality of Life (Stage 2: Non-mentors v. Mentors) [Baseline to 6 months]

    Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)

22. Change in Depression Symptoms (Stage 2: Non-mentors v. Mentors) [Baseline to 6 months]

    As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)

23. Change in Glucose Control (Stage 2: Non-mentors v. Mentors) [Baseline to 12 months]

    Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)

24. Change in Direct LDL Blood Levels (Stage 2: Non-mentors v. Mentors) [Baseline to 12 months]

    Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)

25. Change in Systolic Blood Pressure (Stage 2: Non-mentors v. Mentors) [Baseline to 12 months]

    Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month BP is lower than the baseline BP. (Change = final measure - initial measure)

26. Change in Diabetes Quality of Life (Stage 2: Non-mentors v. Mentors) [Baseline to 12 months]

    Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)

27. Change in Depression Symptoms (Stage 2: Non-mentors v. Mentors) [Baseline to 12 months]

    As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Inclusion Criteria:

• All participants must have a diagnosis of Type 2 diabetics.

• Diabetes began after age 30

• Mentees: Have an HbA1c > 8% on 2 different occasions in the course of 24 months, with at least one measure within 3 months of enrollment

• Mentors for Phase 1: Had an HbA1c of > 8% in the past 3 years and an HbA1c < (or equal to) 7.5% within 3 months of enrollment

• Mentors for Phase 2: Former mentee

Exclusion Criteria:

Exclusion Criteria:

• Does not speak English

• Unable to understand consents

• Severe speech impediment

• over the age of 75

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Judith A. Long, MD, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 13, 2016

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01651117
• Other Study ID Numbers: IIR 12-407
• First Posted: Jul 26, 2012
• Last Update Posted: Oct 30, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: Diabetes Mellitus; Mentors; Glucose control; Hemoglobin A, Glycosylated; Randomized Controlled Trial; Veterans
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

Participant Flow

Arm/Group Title	Stage 1 Usual Care	Stage 1 Peer Mentoring	Stage 2 Usual Care	Stage 2 Peer Mentoring FFM (From Former Mentee)
Arm/Group Description	Poorly controlled diabetics randomized to no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control. For stage 2, they will then be further randomized to either becoming a mentor for 6 months or having no other additional active intervention. All participants in this arm will be evaluated in person at baseline, 6 months, 12 months, and 18 months.	Poorly controlled diabetics randomized to stage 2 no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Poorly controlled diabetics randomized to stage 2 intervention will be mentored by the former mentee for 6 months and will be followed in person for an additional 6 months after the completion of the active intervention.
Period Title: Overall Study
STARTED	156	205	49	70
COMPLETED	154	202	47	68
NOT COMPLETED	2	3	2	2

Baseline Characteristics

Arm/Group Title	Stage 1 Usual Care	Stage 1 Peer Mentoring	Stage 2 Usual Care	Stage 2 Peer Mentoring FFM (From Former Mentee)	Total
Arm/Group Description	Poorly controlled diabetics randomized to no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control. For stage 2, they will then be further randomized to either becoming a mentor for 6 months or having no other additional active intervention. All participants in this arm will be evaluated in person at baseline, 6 months, 12 months, and 18 months.	Poorly controlled diabetics randomized to stage 2 no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Poorly controlled diabetics randomized to stage 2 intervention will be mentored by the former mentee for 6 months and will be followed in person for an additional 6 months after the completion of the active intervention.	Total of all reporting groups
Overall Participants	154	202	47	68	471
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.6 (7.4)	59.6 (7.9)	62.3 (6.8)	62.3 (6.9)	60.6 (7.5)
Sex: Female, Male (Count of Participants)
Female	8 5.2%	7 3.5%	0 0%	2 2.9%	17 3.6%
Male	146 94.8%	195 96.5%	47 100%	66 97.1%	454 96.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	11 7.1%	11 5.4%	4 8.5%	1 1.5%	27 5.7%
Not Hispanic or Latino	143 92.9%	191 94.6%	43 91.5%	67 98.5%	444 94.3%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	40 26%	50 24.8%	9 19.1%	20 29.4%	119 25.3%
Black	93 60.4%	136 67.3%	37 78.7%	45 66.2%	311 66%
Multiple Race	2 1.3%	5 2.5%	0 0%	3 4.4%	10 2.1%
Other Race	19 12.3%	11 5.4%	1 2.1%	0 0%	31 6.6%
Region of Enrollment (Count of Participants)
United States	154 100%	202 100%	47 100%	68 100%	471 100%
Baseline HbA1c (percent) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percent]	9.8 (1.6)	9.3 (1.6)	9.7 (2.0)	9.2 (1.7)	9.5 (1.7)

Outcome Measures

1. Primary Outcome

Title	Change in Glucose Control (Stage 1: Usual Care v. Peer Mentoring)
Description	Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stage 1 Usual Care	Stage 1 Peer Mentoring
Arm/Group Description	Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Measure Participants	154	202
Mean (95% Confidence Interval) [percent]	-0.1978	-0.5246

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stage 1 Usual Care, Stage 1 Peer Mentoring
	Comments
	Type of Statistical Test	Equivalence
	Comments	Mixed methods ANCOVA with patient random effects, to compare change in HbA1c from baseline to 6 months between treatment and control groups.
Statistical Test of Hypothesis	p-Value	0.0611
	Comments	Subject random effect included because same model was used for analyses of 2 separate follow up periods (baseline to 6 month, and baseline to 12 month, reported separately).
	Method	Mixed Models Analysis
	Comments	Multiple imputation used for intent-to-treat analysis.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.3268
	Confidence Interval	(2-Sided) 95%; -0.6690 to 0.0154
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.1739
	Estimation Comments	Negative parameter estimate means decrease in HbA1c was greater for treatment group than for control group.

2. Primary Outcome

Title	Change in Glucose Control (Stage 2: Usual Care v. Mentees)
Description	Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stage 2 Usual Care	Stage 2 Peer Mentoring FFM (From Former Mentee)
Arm/Group Description	Poorly controlled diabetics randomized to stage 2 no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Poorly controlled diabetics randomized to stage 2 intervention will be mentored by the former mentee for 6 months and will be followed in person for an additional 6 months after the completion of the active intervention.
Measure Participants	47	68
Mean (95% Confidence Interval) [percent]	-0.4587	0.0772

3. Primary Outcome

Title	Change in Glucose Control (Stage 2: Non-mentors v. Mentors)
Description	Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).

Arm/Group Title	Stage 2 Non-mentor	Stage 2 Mentor
Arm/Group Description	Patients who received peer mentoring in stage 1 who were randomized to no further treatment.	Patients who received peer mentoring in stage 1 who were randomized to become mentors to poorly controlled diabetics.
Measure Participants	69	70
Mean (95% Confidence Interval) [percent]	0.3156	0.1449

4. Secondary Outcome

Title	Change in Direct LDL Blood Levels
Description	Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stage 1 Usual Care	Stage 1 Peer Mentoring
Arm/Group Description	Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Measure Participants	154	202
Mean (95% Confidence Interval) [mg/dL]	-2.0793	-4.3098

5. Secondary Outcome

Title	Change in Systolic Blood Pressure
Description	Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month BP is lower than the baseline BP. (Change = final measure - initial measure)
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stage 1 Usual Care	Stage 1 Peer Mentoring
Arm/Group Description	Poorly controlled diabetics randomized to no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Measure Participants	154	202
Mean (95% Confidence Interval) [mmHG]	-3.4477	-0.8695

6. Secondary Outcome

Title	Change in Diabetes Quality of Life Score
Description	Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stage 1 Usual Care	Stage 1 Peer Mentoring
Arm/Group Description	Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Measure Participants	154	202
Mean (95% Confidence Interval) [score on a scale]	0.0159	-0.0371

7. Secondary Outcome

Title	Change in Depression Symptoms
Description	As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stage 1 Usual Care	Stage 1 Peer Mentoring
Arm/Group Description	Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Measure Participants	154	202
Mean (95% Confidence Interval) [score on a scale]	-0.0502	-0.0389

8. Secondary Outcome

Title	Change in Glucose Control
Description	Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stage 1 Usual Care	Stage 1 Peer Mentoring
Arm/Group Description	Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Measure Participants	154	202
Mean (95% Confidence Interval) [percent]	-0.2643	-0.2818

9. Secondary Outcome

Title	Change in Direct LDL Blood Levels
Description	Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stage 1 Usual Care	Stage 1 Peer Mentoring
Arm/Group Description	Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Measure Participants	154	202
Mean (95% Confidence Interval) [mg/dL]	-7.1706	-7.8594

10. Secondary Outcome

Title	Change in Systolic Blood Pressure
Description	Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month BP is lower than the baseline BP. (Change = final measure - initial measure)
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stage 1 Usual Care	Stage 1 Peer Mentoring
Arm/Group Description	Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Measure Participants	154	202
Mean (95% Confidence Interval) [mmHG]	-3.7548	-2.3274

11. Secondary Outcome

Title	Change in Diabetes Quality of Life
Description	Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stage 1 Usual Care	Stage 1 Peer Mentoring
Arm/Group Description	Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Measure Participants	154	202
Mean (95% Confidence Interval) [score on a scale]	-0.1213	-0.1812

12. Secondary Outcome

Title	Change in Depression Symptoms
Description	As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stage 1 Usual Care	Stage 1 Peer Mentoring
Arm/Group Description	Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Measure Participants	154	202
Mean (95% Confidence Interval) [score on a scale]	-0.1168	-0.1736

13. Secondary Outcome

Title	Change in Direct LDL Blood Levels (Stage 2: Usual Care v. Mentees)
Description	Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stage 2 Usual Care	Stage 2 Peer Mentoring FFM (From Former Mentee)
Arm/Group Description	Poorly controlled diabetics randomized to stage 2 no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Poorly controlled diabetics randomized to stage 2 intervention will be mentored by the former mentee for 6 months and will be followed in person for an additional 6 months after the completion of the active intervention.
Measure Participants	47	68
Mean (95% Confidence Interval) [mg/dL]	7.9124	-1.6217

14. Secondary Outcome

Title	Change in Systolic Blood Pressure (Stage 2: Usual Care v. Mentee)
Description	Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month BP is lower than the baseline BP. (Change = final measure - initial measure)
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stage 2 Usual Care	Stage 2 Peer Mentoring FFM (From Former Mentee)
Arm/Group Description	Poorly controlled diabetics randomized to stage 2 no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Poorly controlled diabetics randomized to stage 2 intervention will be mentored by the former mentee for 6 months and will be followed in person for an additional 6 months after the completion of the active intervention.
Measure Participants	47	68
Mean (95% Confidence Interval) [mmHG]	1.4718	0.1876

15. Secondary Outcome

Title	Change in Diabetes Quality of Life (Stage 2: Usual Care v. Mentee)
Description	Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stage 2 Usual Care	Stage 2 Peer Mentoring FFM (From Former Mentee)
Arm/Group Description	Poorly controlled diabetics randomized to stage 2 no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Poorly controlled diabetics randomized to stage 2 intervention will be mentored by the former mentee for 6 months and will be followed in person for an additional 6 months after the completion of the active intervention.
Measure Participants	47	68
Mean (95% Confidence Interval) [score on a scale]	0.1024	-0.4098

16. Secondary Outcome

Title	Change in Depression Symptoms (Stage 2: Usual Care v. Mentees)
Description	As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stage 2 Usual Care	Stage 2 Peer Mentoring FFM (From Former Mentee)
Arm/Group Description	Poorly controlled diabetics randomized to stage 2 no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Poorly controlled diabetics randomized to stage 2 intervention will be mentored by the former mentee for 6 months and will be followed in person for an additional 6 months after the completion of the active intervention.
Measure Participants	47	68
Mean (95% Confidence Interval) [score on a scale]	-0.3186	-0.2627

17. Secondary Outcome

Title	Change in Glucose Control (Stage 2: Usual Care v. Mentees)
Description	Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stage 2 Usual Care	Stage 2 Peer Mentoring FFM (From Former Mentee)
Arm/Group Description	Poorly controlled diabetics randomized to stage 2 no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Poorly controlled diabetics randomized to stage 2 intervention will be mentored by the former mentee for 6 months and will be followed in person for an additional 6 months after the completion of the active intervention.
Measure Participants	47	68
Mean (95% Confidence Interval) [percent]	-0.2661	-0.1628

18. Secondary Outcome

Title	Change in Direct LDL Blood Levels (Stage 2: Usual Care v. Mentees)
Description	Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stage 2 Usual Care	Stage 2 Peer Mentoring FFM (From Former Mentee)
Arm/Group Description	Poorly controlled diabetics randomized to stage 2 no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Poorly controlled diabetics randomized to stage 2 intervention will be mentored by the former mentee for 6 months and will be followed in person for an additional 6 months after the completion of the active intervention.
Measure Participants	47	68
Mean (95% Confidence Interval) [mg/dL]	5.0419	-4.9126

19. Secondary Outcome

Title	Change in Systolic Blood Pressure (Stage 2: Usual Care v. Mentee)
Description	Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month BP is lower than the baseline BP. (Change = final measure - initial measure)
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stage 2 Usual Care	Stage 2 Peer Mentoring FFM (From Former Mentee)
Arm/Group Description	Poorly controlled diabetics randomized to stage 2 no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Poorly controlled diabetics randomized to stage 2 intervention will be mentored by the former mentee for 6 months and will be followed in person for an additional 6 months after the completion of the active intervention.
Measure Participants	47	68
Mean (95% Confidence Interval) [mmHG]	-1.6851	1.3877

20. Secondary Outcome

Title	Change in Diabetes Quality of Life (Stage 2: Usual Care v. Mentee)
Description	Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stage 2 Usual Care	Stage 2 Peer Mentoring FFM (From Former Mentee)
Arm/Group Description	Poorly controlled diabetics randomized to stage 2 no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Poorly controlled diabetics randomized to stage 2 intervention will be mentored by the former mentee for 6 months and will be followed in person for an additional 6 months after the completion of the active intervention.
Measure Participants	47	68
Mean (95% Confidence Interval) [score on a scale]	-0.1299	-0.0246

21. Secondary Outcome

Title	Change in Depression Symptoms (Stage 2: Usual Care v. Mentees)
Description	As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stage 2 Usual Care	Stage 2 Peer Mentoring FFM (From Former Mentee)
Arm/Group Description	Poorly controlled diabetics randomized to stage 2 no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Poorly controlled diabetics randomized to stage 2 intervention will be mentored by the former mentee for 6 months and will be followed in person for an additional 6 months after the completion of the active intervention.
Measure Participants	47	68
Mean (95% Confidence Interval) [score on a scale]	-0.4581	-0.0890

22. Secondary Outcome

Title	Change in Direct LDL Blood Levels (Stage 2: Non-mentors v. Mentors)
Description	Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).

Arm/Group Title	Stage 2 Non-mentor	Stage 2 Mentor
Arm/Group Description	Patients who received peer mentoring in stage 1 who were randomized to no further treatment.	Patients who received peer mentoring in stage 1 who were randomized to become mentors to poorly controlled diabetics.
Measure Participants	69	70
Mean (95% Confidence Interval) [mg/dL]	-2.1692	-7.4649

23. Secondary Outcome

Title	Change in Systolic Blood Pressure (Stage 2: Non-mentors v. Mentors)
Description	Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month BP is lower than the baseline BP. (Change = final measure - initial measure)
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).

Arm/Group Title	Stage 2 Non-mentor	Stage 2 Mentor
Arm/Group Description	Patients who received peer mentoring in stage 1 who were randomized to no further treatment.	Patients who received peer mentoring in stage 1 who were randomized to become mentors to poorly controlled diabetics.
Measure Participants	69	70
Mean (95% Confidence Interval) [mmHG]	-1.6942	-1.0527

24. Secondary Outcome

Title	Change in Diabetes Quality of Life (Stage 2: Non-mentors v. Mentors)
Description	Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).

Arm/Group Title	Stage 2 Non-mentor	Stage 2 Mentor
Arm/Group Description	Patients who received peer mentoring in stage 1 who were randomized to no further treatment.	Patients who received peer mentoring in stage 1 who were randomized to become mentors to poorly controlled diabetics.
Measure Participants	69	70
Mean (95% Confidence Interval) [score on a scale]	-0.1006	-0.1332

25. Secondary Outcome

Title	Change in Depression Symptoms (Stage 2: Non-mentors v. Mentors)
Description	As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).

Arm/Group Title	Stage 2 Non-mentor	Stage 2 Mentor
Arm/Group Description	Patients who received peer mentoring in stage 1 who were randomized to no further treatment.	Patients who received peer mentoring in stage 1 who were randomized to become mentors to poorly controlled diabetics.
Measure Participants	69	70
Mean (95% Confidence Interval) [score on a scale]	-0.3314	-0.1809

26. Secondary Outcome

Title	Change in Glucose Control (Stage 2: Non-mentors v. Mentors)
Description	Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description

After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).

Arm/Group Title	Stage 2 Non-mentor	Stage 2 Mentor
Arm/Group Description	Patients who received peer mentoring in stage 1 who were randomized to no further treatment.	Patients who received peer mentoring in stage 1 who were randomized to become mentors to poorly controlled diabetics.
Measure Participants	69	70
Mean (95% Confidence Interval) [percent]	0.2396	0.0639

27. Secondary Outcome

Title	Change in Direct LDL Blood Levels (Stage 2: Non-mentors v. Mentors)
Description	Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description

After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).

Arm/Group Title	Stage 2 Non-mentor	Stage 2 Mentor
Arm/Group Description	Patients who received peer mentoring in stage 1 who were randomized to no further treatment.	Patients who received peer mentoring in stage 1 who were randomized to become mentors to poorly controlled diabetics.
Measure Participants	69	70
Mean (95% Confidence Interval) [mg/dL]	-1.0938	2.2494

28. Secondary Outcome

Title	Change in Systolic Blood Pressure (Stage 2: Non-mentors v. Mentors)
Description	Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month BP is lower than the baseline BP. (Change = final measure - initial measure)
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description

After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).

Arm/Group Title	Stage 2 Non-mentor	Stage 2 Mentor
Arm/Group Description	Patients who received peer mentoring in stage 1 who were randomized to no further treatment.	Patients who received peer mentoring in stage 1 who were randomized to become mentors to poorly controlled diabetics.
Measure Participants	69	70
Mean (95% Confidence Interval) [mmHG]	-3.9453	-0.5611

29. Secondary Outcome

Title	Change in Diabetes Quality of Life (Stage 2: Non-mentors v. Mentors)
Description	Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description

After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).

Arm/Group Title	Stage 2 Non-mentor	Stage 2 Mentor
Arm/Group Description	Patients who received peer mentoring in stage 1 who were randomized to no further treatment.	Patients who received peer mentoring in stage 1 who were randomized to become mentors to poorly controlled diabetics.
Measure Participants	69	70
Mean (95% Confidence Interval) [score on a scale]	-0.1896	-0.3017

30. Secondary Outcome

Title	Change in Depression Symptoms (Stage 2: Non-mentors v. Mentors)
Description	As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description

After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).

Arm/Group Title	Stage 2 Non-mentor	Stage 2 Mentor
Arm/Group Description	Patients who received peer mentoring in stage 1 who were randomized to no further treatment.	Patients who received peer mentoring in stage 1 who were randomized to become mentors to poorly controlled diabetics.
Measure Participants	69	70
Mean (95% Confidence Interval) [score on a scale]	0.0609	-0.0819

Adverse Events

Time Frame	Adverse event data were collected for 18 months from baseline.
Arm/Group Title	Usual Care Stage 1		Peer Mentoring		Peer Mentoring FFM (From Former Mentee)		Usual Care Stage 2
Arm/Group Description	No interventions will be provided to this arm. They will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).		Participants in this arm will be mentored for 6 months by a veteran who was once in poor control but is now in good control. They will then be further randomized to either becoming a mentor for 6 months or having no other additional active intervention. All participants in this arm will be evaluated in person at baseline, 6 months, 12 months, and 18 months.		Participants in this arm will be mentored by the former mentee for 6 months and will be followed in person for an additional 6 months after the completion of the active intervention.		No interventions will be provided to this arm. They will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).
All Cause Mortality
	Usual Care Stage 1		Peer Mentoring		Peer Mentoring FFM (From Former Mentee)		Usual Care Stage 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/156 (1.3%)		3/205 (1.5%)		2/70 (2.9%)		2/49 (4.1%)
Serious Adverse Events
	Usual Care Stage 1		Peer Mentoring		Peer Mentoring FFM (From Former Mentee)		Usual Care Stage 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/156 (6.4%)		28/205 (13.7%)		12/70 (17.1%)		2/49 (4.1%)
Cardiac disorders
Hospitalization	0/156 (0%)	0	6/205 (2.9%)	8	5/70 (7.1%)	9	1/49 (2%)	1
Endocrine disorders
Hospitalization	1/156 (0.6%)	1	0/205 (0%)	0	0/70 (0%)	0	1/49 (2%)	1
Gastrointestinal disorders
Hospitalization	0/156 (0%)	0	2/205 (1%)	2	0/70 (0%)	0	0/49 (0%)	0
General disorders
Hospitalization	4/156 (2.6%)	4	15/205 (7.3%)	15	3/70 (4.3%)	4	1/49 (2%)	1
Immune system disorders
Hospitalization	0/156 (0%)	0	3/205 (1.5%)	3	0/70 (0%)	0	0/49 (0%)	0
Infections and infestations
Hospitalization	3/156 (1.9%)	3	3/205 (1.5%)	3	0/70 (0%)	0	0/49 (0%)	0
Injury, poisoning and procedural complications
Hospitalization	0/156 (0%)	0	2/205 (1%)	2	0/70 (0%)	0	0/49 (0%)	0
Musculoskeletal and connective tissue disorders
Hospitalization	0/156 (0%)	0	0/205 (0%)	0	0/70 (0%)	0	0/49 (0%)	0
Nervous system disorders
Hospitalization	3/156 (1.9%)	3	3/205 (1.5%)	3	2/70 (2.9%)	2	0/49 (0%)	0
Psychiatric disorders
Hospitalization	0/156 (0%)	0	1/205 (0.5%)	1	1/70 (1.4%)	3	1/49 (2%)	1
Renal and urinary disorders
Hospitalization	1/156 (0.6%)	1	5/205 (2.4%)	5	0/70 (0%)	0	0/49 (0%)	0
Reproductive system and breast disorders
Hospitalization	0/156 (0%)	0	1/205 (0.5%)	1	0/70 (0%)	0	0/49 (0%)	0
Respiratory, thoracic and mediastinal disorders
Hospitalization	0/156 (0%)	0	1/205 (0.5%)	1	0/70 (0%)	0	0/49 (0%)	0
Surgical and medical procedures
Hospitalization	1/156 (0.6%)	1	2/205 (1%)	2	1/70 (1.4%)	1	1/49 (2%)	1
Other (Not Including Serious) Adverse Events
	Usual Care Stage 1		Peer Mentoring		Peer Mentoring FFM (From Former Mentee)		Usual Care Stage 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/156 (7.1%)		38/205 (18.5%)		6/70 (8.6%)		5/49 (10.2%)
Cardiac disorders
ED visit	1/156 (0.6%)	1	0/205 (0%)	0	0/70 (0%)	0	0/49 (0%)	0
General disorders
ED visit	1/156 (0.6%)	1	21/205 (10.2%)	26	0/70 (0%)	0	2/49 (4.1%)	2
Infections and infestations
ED visit	0/156 (0%)	0	4/205 (2%)	5	0/70 (0%)	0	1/49 (2%)	1
Injury, poisoning and procedural complications
ED visit	3/156 (1.9%)	3	7/205 (3.4%)	8	3/70 (4.3%)	3	1/49 (2%)	1
Musculoskeletal and connective tissue disorders
ED visit	1/156 (0.6%)	1	1/205 (0.5%)	1	0/70 (0%)	0	0/49 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ED visit	0/156 (0%)	0	1/205 (0.5%)	1	0/70 (0%)	0	0/49 (0%)	0
Nervous system disorders
ED visit	0/156 (0%)	0	1/205 (0.5%)	1	0/70 (0%)	0	0/49 (0%)	0
Renal and urinary disorders
ED visit	1/156 (0.6%)	1	0/205 (0%)	0	0/70 (0%)	0	0/49 (0%)	0
Reproductive system and breast disorders
ED visit	0/156 (0%)	0	2/205 (1%)	2	0/70 (0%)	0	0/49 (0%)	0
Respiratory, thoracic and mediastinal disorders
ED visit	0/156 (0%)	0	3/205 (1.5%)	5	1/70 (1.4%)	1	0/49 (0%)	0
Skin and subcutaneous tissue disorders
ED visit	2/156 (1.3%)	2	1/205 (0.5%)	1	0/70 (0%)	0	0/49 (0%)	0
Surgical and medical procedures
ED visit	3/156 (1.9%)	3	4/205 (2%)	6	2/70 (2.9%)	2	2/49 (4.1%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.