ACDC: Advanced Comprehensive Diabetes Care for Veterans With Poorly-Controlled Diabetes

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01778751
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

This study will determine whether Home Telehealth-based implementation of an evidence-based intervention targeting Veterans with persistent poorly-controlled diabetes can improve hemoglobin A1c, patient self-management, and comorbid depressive symptoms in this high-risk, high-cost population. If effective, this intervention (Advanced Comprehensive Diabetes Care) offers a feasible, sustainable, and generalizable approach to managing Veterans with persistent poorly-controlled diabetes, which can be implemented using only existing Home Telehealth services.

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Behavioral: Home Telehealth with Behavioral Education Component	Early Phase 1

Detailed Description

Background: Although efforts by VA providers and researchers have improved diabetes care quality for Veterans, individuals with persistent poorly-controlled diabetes mellitus (type 1 or type 2 diabetes with hemoglobin A1c >9.0% for > 1 year despite receipt of medical care) have proven refractory to these widespread improvements, and remain at high risk for complications and accrued costs. Prior research has illustrated that medication regimen complexity, suboptimal self-care, and comorbid depressive symptoms interact to perpetuate suboptimal control among individuals with PPDM. Current models of clinic-based diabetes care do not meet these Veterans' needs. Without the implementation of care delivery strategies that target this population's unique barriers to improved diabetes control, these Veterans will continue to be left behind by progress in diabetes management throughout VA, and will remain at high risk for complications and high costs. We propose using existing local Home Telehealth services to implement Advanced Comprehensive Diabetes Care, a patient-centered, evidence-based intervention combining medication management, self-care behavior support, and depressive symptom management to Veterans with PPDM.

Objectives: The specific aims of this RRP are to: 1) evaluate the effectiveness of the Advanced Comprehensive Diabetes Care among Veterans with persistent poorly-controlled diabetes; 2) utilize a mixed method formative evaluation to assess our main implementation strategy, the use of existing Home Telehealth services to administer the intervention; and 3) generate data we will use to refine local intervention implementation and inform the development of an SDP proposal evaluating broader implementation of the Advanced Comprehensive Diabetes Care intervention.

Methods: We propose a pilot Effectiveness-Implementation Hybrid trial to study the Advanced Comprehensive Diabetes Care intervention in Veterans with persistent poorly-controlled diabetes. After baseline evaluation, 50 Veterans will be randomly assigned into intervention (n = 25) or control groups (n = 25). Veterans randomized to the intervention will be enrolled in the Home Telehealth program at Durham VAMC and will receive the study intervention (telehealth-based medication management, self-care behavior support, and depressive symptom management) for 6 months. Intervention-group Veterans with no depression on baseline assessment will not initially receive the depressive symptom management component, but will be monitored for new symptoms throughout the study. Veterans randomized to the control arm will receive diabetes educational materials and management per their primary provider. The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms. This RRP will also include a mixed method formative evaluation to qualitatively and quantitatively assess patient-level, provider-level, and organizational barriers and facilitators influencing intervention implementation. Formative evaluation data will be analyzed during the study to consider whether adjustments to the intervention or its implementation may be indicated, and findings will also be used to inform future implementation efforts.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Advanced Comprehensive Diabetes Care for Veterans With Poorly-Controlled Diabetes
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Veterans will receive diabetes educational materials and management per their primary provider
Experimental: Intervention Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.	Behavioral: Home Telehealth with Behavioral Education Component; The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms.

Outcome Measures

Primary Outcome Measures

1. Diabetes Control [Baseline, 3months, 6months]

   Hemoglobin A1c as measured at baseline, 3m, 6m

Secondary Outcome Measures

1. Diabetes Self Care [Baseline, 3m, 6m]

   Self-Care Inventory-revised as measured at baseline, 3 months, 6 months

2. Self-reported Medication Adherence [Baseline, 3m, 6m]

   Change in Self-Reported Medication- Taking Scale as measured at baseline, 3 months, 6 months

3. Depressive Symptoms [Baseline, 3m, 6m]

   Change in Patient Health Questionnaire as measured at Baseline, 3 months, 6 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Veterans with type 2 diabetes managed for > 1 year at an eligible site (Durham, Raleigh, Greenville, or Morehead City) will be eligible for enrollment.

• We will identify Veterans with PPDM (defined as the presence of at least 2 A1c values of > 9.0% during the past year with no readings of < 9.0% despite ongoing medical care) by reviewing electronic medical records and soliciting referrals from primary physicians.

Exclusion Criteria:

• Exclusion criteria will include lack of telephone access or severe hearing/ speech impairment that would limit:

• telephone interaction

• metastatic cancer

• active psychosis documented in medical record

• active alcohol or substance abuse

• diagnosis of dementia

• known pregnancy (patients becoming pregnant during the study will be withdrawn and referred to appropriate services)

• documented seizure history

• documented history of severe complications of hypoglycemia (such as coma or seizure)

• documented refusal or inability to perform self-monitoring of blood glucose

• ongoing use of warfarin with prior history of major bleeding event

• Due to challenges with dose adjustment by phone, Veterans on continuous subcutaneous insulin infusion (insulin pumps) will not be eligible for this study.

• Due to challenges with regulations regarding testing supplies pts will need to be taking insulin (a few patients had enrolled prior to this change.).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Durham VA Medical Center, Durham, NC	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Matthew J Crowley, MD, Durham VA Medical Center, Durham, NC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01778751
• Other Study ID Numbers: RRP 12-458
• First Posted: Jan 29, 2013
• Last Update Posted: Jan 25, 2016
• Last Verified: Dec 1, 2015

• Keywords provided by VA Office of Research and Development: Self-Management Support; Depression; Home Telehealth
• Additional relevant MeSH terms: Diabetes Mellitus

Study Results

Participant Flow

Recruitment Details	Recruitment occurred December 2013-May 2014 at the Durham VA Medical Center outpatient primary care clinics.

Arm/Group Title	Control	Intervention
Arm/Group Description	Veterans will receive diabetes educational materials and management per their primary provider	Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention. Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms.
Period Title: Overall Study
STARTED	25	25
COMPLETED	23	23
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Control	Intervention	Total
Arm/Group Description	Veterans will receive diabetes educational materials and management per their primary provider	Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention. Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms.	Total of all reporting groups
Overall Participants	25	25	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.5 (9.2)	60.2 (8.4)	59.9 (8.7)
Sex: Female, Male (Count of Participants)
Female	0 0%	2 8%	2 4%
Male	25 100%	23 92%	48 96%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 8%	1 4%	3 6%
Not Hispanic or Latino	23 92%	24 96%	47 94%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	15 60%	12 48%	27 54%
White	8 32%	13 52%	21 42%
More than one race	1 4%	0 0%	1 2%
Unknown or Not Reported	1 4%	0 0%	1 2%
Region of Enrollment (participants) [Number]
United States	25 100%	25 100%	50 100%

Outcome Measures

1. Primary Outcome

Title	Diabetes Control
Description	Hemoglobin A1c as measured at baseline, 3m, 6m
Time Frame	Baseline, 3months, 6months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Intervention
Arm/Group Description	Veterans will receive diabetes educational materials and management per their primary provider	Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention. Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms.
Measure Participants	25	25
Baseline	10.7 (1.6)	10.2 (1.4)
3 Months	10.3 (1.8)	9.1 (1.3)
6 months	10.4 (1.6)	9.1 (2.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Intervention
	Comments	Comparison at 3 months
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.012
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.0
	Confidence Interval	(2-Sided) 95%; -1.7 to -0.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Control, Intervention
	Comments	Comparison at 6 months
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.050
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.0
	Confidence Interval	(2-Sided) 95%; -2.0 to -0.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Diabetes Self Care
Description	Self-Care Inventory-revised as measured at baseline, 3 months, 6 months
Time Frame	Baseline, 3m, 6m

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Intervention
Arm/Group Description	Veterans will receive diabetes educational materials and management per their primary provider	Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention. Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms.
Measure Participants	25	25
Baseline	49.8 (9.6)	52.3 (14.8)
3 months	53.7 (10.9)	58.2 (14.6)
6 months	52.6 (12.6)	61.1 (14.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Intervention
	Comments	Comparison at 3 months, Scale is 0-100 where a higher score is a better outcome.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.303
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.9
	Confidence Interval	(2-Sided) 95%; -2.7 to 8.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Control, Intervention
	Comments	Comparison at 6 months, Scale is 0-100 where a higher score is a better outcome.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.027
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	7.7
	Confidence Interval	(2-Sided) 95%; 0.9 to 14.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Self-reported Medication Adherence
Description	Change in Self-Reported Medication- Taking Scale as measured at baseline, 3 months, 6 months
Time Frame	Baseline, 3m, 6m

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Intervention
Arm/Group Description	Veterans will receive diabetes educational materials and management per their primary provider	Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention. Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms.
Measure Participants	25	25
Baseline	17 68%	15 60%
3 months	11 44%	9 36%
6 months	9 36%	8 32%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Intervention
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.830
	Comments
	Method	Generalized estimating equation (GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.35 to 2.34
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Control, Intervention
	Comments	Comparison at 6 months
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.970
	Comments
	Method	Generalized Estimating Equation (GEE)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.33 to 3.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Depressive Symptoms
Description	Change in Patient Health Questionnaire as measured at Baseline, 3 months, 6 months
Time Frame	Baseline, 3m, 6m

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Intervention
Arm/Group Description	Veterans will receive diabetes educational materials and management per their primary provider	Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention. Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms.
Measure Participants	25	25
Baseline	7.3 (5.5)	6.9 (5.6)
3 months	6.6 (5.1)	5.5 (6.3)
6 months	5.9 (4.7)	6.7 (6.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Intervention
	Comments	Comparison at 3 months. Scale is 0-27 where a lower score is a better outcome, values were dichotomized to indicate whether or not the patient was depressed.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.428
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.9
	Confidence Interval	(2-Sided) 95%; -3.3 to 1.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Control, Intervention
	Comments	Comparison at 6 months. Scale is 0-27 where a lower score is a better outcome, values were dichotomized to indicate whether or not the patient was depressed.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.397
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; -1.4 to 3.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts.
Adverse Event Reporting Description	Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.
Arm/Group Title	Control		Intervention
Arm/Group Description	Veterans will receive diabetes educational materials and management per their primary provider		Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention. Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms.
All Cause Mortality
	Control		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/25 (16%)		3/25 (12%)
Cardiac disorders
Hospitalization	1/25 (4%)	1	1/25 (4%)	1
General disorders
Hospitalization	0/25 (0%)	0	1/25 (4%)	1
Investigations
Hypoglycemia Requiring Asssistance	0/25 (0%)	0	0/25 (0%)	0
Psychiatric disorders
Hospitalization	1/25 (4%)	1	0/25 (0%)	0
Psychiatric Disorder	1/25 (4%)	1	0/25 (0%)	0
Renal and urinary disorders
Hospitalization	0/25 (0%)	0	1/25 (4%)	1
Respiratory, thoracic and mediastinal disorders
Hospitalization	1/25 (4%)	1	1/25 (4%)	1
Outpatient Diagnosis	1/25 (4%)	1	0/25 (0%)	0
Other (Not Including Serious) Adverse Events
	Control		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/25 (48%)		14/25 (56%)
Ear and labyrinth disorders
Ear infection	0/25 (0%)	0	1/25 (4%)	1
Endocrine disorders
Biopsy	0/25 (0%)	0	1/25 (4%)	1
Hyperglycemia	0/25 (0%)	0	1/25 (4%)	1
Eye disorders
Eye pain	1/25 (4%)	1	0/25 (0%)	0
General disorders
Emergency Room Visit	6/25 (24%)	12	7/25 (28%)	9
Infections and infestations
Emergency Room Visit	1/25 (4%)	1	3/25 (12%)	3
Investigations
# Pts with >5 BG Values <70 mg/dL from 1st encounter to end of study	0/25 (0%)	0	3/25 (12%)	3
Musculoskeletal and connective tissue disorders
Emergency Room Visit	3/25 (12%)	3	1/25 (4%)	1
Psychiatric disorders
Psychiatric Disorder	1/25 (4%)	1	0/25 (0%)	0
Renal and urinary disorders
Emergency Room Visit	1/25 (4%)	1	2/25 (8%)	2
Respiratory, thoracic and mediastinal disorders
Emergency Room Visit	1/25 (4%)	1	1/25 (4%)	1
Skin and subcutaneous tissue disorders
Biopsy	1/25 (4%)	2	0/25 (0%)	0
cellulitis	1/25 (4%)	1	0/25 (0%)	0
Surgical and medical procedures
Planned Surgery and Proceedures	1/25 (4%)	1	2/25 (8%)	3
Vascular disorders
Emergency Room Visit	1/25 (4%)	1	1/25 (4%)	1

Limitations/Caveats

Single-center pilot study Small, male Veteran population with type 2 diabetes Uses VA-specific infrastructure, findings may not translate to other settings.

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.