MITI: Mobile Insulin Titration Intervention

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT01879579
• Collaborator: New York City Health and Hospitals Corporation (Other)
• Enrollment: 61
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

The purpose of this pilot study is to determine whether text message (and phone) communication can be effectively utilized to adjust long-acting insulin, compared to standard practice.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Other: Mobile Insulin Titration Intervention	N/A

Detailed Description

The current practice of insulin titration for diabetics requires multiple in-person clinic visits, during which a patient's long-acting insulin dose is adjusted until the optimal dose to control glycemia is reached. Finding this optimal dose can take weeks in an ideal setting, but often takes much longer in a busy urban clinic such as Bellevue Hospital Center. Relaying titration instructions to patients via phone and text message has the potential to decrease the titration timeline, thus reducing the number of clinic visits and the time it takes patients to reach their target blood glucose levels.

For this pilot project, study staff will recruit patients who are initiating long-acting insulin treatment or initiating the titration of their existing long acting insulin treatment at Bellevue Hospital Center's Adult Primary Care Center. Patients who volunteer to enroll and provide informed consent will be randomized to one of two arms (MITI or current best practice arm) at the time of enrollment and stratified by whether the patient is initiating insulin treatment or initiating the titration of his/her existing insulin dose. The study staff will provide a cell phone (for temporary use) to any patients who are randomized to the MITI arm and don't own a personal cell phone (or whose personal cell phone is not able to receive the Sense Health text messages). Patients will use the cell phone free of cost to participate in the intervention (receive Sense Health text messages, send their fasting blood glucose levels, and speak with the diabetes nurse and study staff.)

Patients in the MITI arm will receive automated text messages 5 weekdays per week, for up to 12 weeks, from Sense Health. These text messages will request the patient's fasting blood glucose level. The patient will reply with his/her fasting blood glucose value, which will be logged in password-protected accounts on www.sensehealth.com. The clinic's diabetes nurses will check each patient's fasting blood glucose level on www.sensehealth.com each weekday and call any patient with fasting blood glucose values < 80 mg/dL and > 400 mg/dL. Each Thursday, patients will receive a phone call from a nurse, who will adjust the patient's insulin dose according to the study titration protocol. Each patient will continue to receive daily text messages and weekly phone calls until the first of three events occur: the patient reaches his/her optimal insulin dose for achieving glycemic control, 12 weeks elapse, or the patient withdraws from the study.

Patients in the current best practice arm (CBP) will attend scheduled clinic appointments during which a provider will review the patient's fasting blood glucose log and titrate the insulin dose according to current best practice.

Patients in both arms will continue receiving routine care, including HbA1c values every 3 months and other routine labs and measures as per standard of care.

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Mobile Insulin Titration Intervention (MITI) Study: Innovative Chronic Disease Management of Diabetes
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mobile Insulin Titration Intervention Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.	Other: Mobile Insulin Titration Intervention; Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.
No Intervention: Current Best Practice Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose [12 weeks]

Secondary Outcome Measures

1. Time to Reach Optimal Long-acting Insulin Dose [12 weeks]

   The time it takes a patient to reach his/her optimal long-acting insulin dose will be measured for both study arms.

2. Hemoglobin A1c [baseline, 12 weeks (approximately 3 months)]

   Change in hemoglobin A1c

3. Baseline Treatment Satisfaction [baseline]

   The Diabetes Treatment Satisfaction Questionnaire standard (DTSQs) will be used to measure the patient's satisfaction with diabetes treatment received prior to study participation. Scores on questionnaire range from 0 to 6: 0 = very dissatisfied, 6 = very satisfied.

4. Treatment Satisfaction After Initiation of Insulin Titration [12 weeks (approximately 3 months)]

   The Diabetes Treatment Satisfaction Questionnaire standard (DTSQs) will be used to measure the patient's satisfaction with diabetes treatment received since initiation of long-acting insulin titration. Scores on questionnaire range from 0 to 6: 0 = very dissatisfied, 6 = very satisfied.

5. Change in Treatment Satisfaction [12 weeks (approximately 3 months)]

   The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) will be used to measure the change in the patient's satisfaction with his/her diabetes treatment since initiation of long-acting insulin titration. Scores on questionnaire range from -3 to +3: -3 = much less satisfied now, +3 = much more satisfied now.

6. Incidence of Hypoglycemia [12 weeks]

   The number of instances of hypoglycemia as indicated by fasting blood glucose levels or symptoms reported by patients in both study arms.

Other Outcome Measures

1. Percentage of Text Message Responses [12 weeks]

   The number of text message replies from participants compared to the total number of text messages sent to participants (asking for blood glucose values). This outcome is given as a percent.

2. Percentage of Successful Phone Calls [12 weeks]

   The number of successful insulin titration phone calls compared to the total number of insulin titration phone calls assigned to the nurse. Successful phone calls are defined as when the nurse was able to reach the participant with one call attempt, two call attempts, or by voicemail. This outcome is given as a percent.

3. Patient Healthcare Utilization [12 weeks]

   The number of medication refill, emergency department, and walk-in clinic visits at Bellevue Hospital (non-insulin titration visits).

4. Costs - Provider Time Spent on Insulin Titration Visits [12 weeks]

   Provider time spent on insulin titration visits by phone compared to insulin titration visits in the clinic.

5. Costs - Titration Visit Information [12 weeks]

   The number of insulin titration visits (whether by phone or in the clinic).

6. Costs - Patient Travel Time [12 weeks]

   The time it took patients to travel to Bellevue Hospital, reported by patients in both study arms at baseline and at any subsequent clinic visits.

7. Costs - Co-pays [baseline]

   At baseline, participants in both study arms (MITI and CBP) reported whether they had to pay co-pays for clinic visits at Bellevue Hospital.

8. Qualitative Patient Satisfaction Interview [After patient reaches optimal insulin dose or at 12 weeks]

   The study staff will interview MITI arm patients, using free-response questions, to assess their satisfaction with the intervention. The interviews will take place in person or over the phone at the patient's convenience, after the patient has reached his/her optimal insulin dose. If the patient does not reach optimal insulin dose, the interview will take place at approximately 12 weeks.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Initiating long-acting insulin treatment or initiating the titration of long-acting insulin treatment

• Speaks English or Spanish

• Hemoglobin A1c > or = 8%

• Able and willing to inject insulin

• Able and willing to provide informed consent

Exclusion Criteria:

• Short-acting insulin treatment

• Systemic glucocorticoids

• Sustained elevated serum creatinine > or = 1.5 mg/dL for men and > or = 1.4 mg/dL for women

• Hypoglycemia unawareness

• Type 1 diabetes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Adult Primary Care Clinic, Bellevue Hospital Center	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health
• New York City Health and Hospitals Corporation

Investigators

• Principal Investigator: Natalie Levy, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

• Arora S, Peters AL, Agy C, Menchine M. A mobile health intervention for inner city patients with poorly controlled diabetes: proof-of-concept of the TExT-MED program. Diabetes Technol Ther. 2012 Jun;14(6):492-6. doi: 10.1089/dia.2011.0252. Epub 2012 Apr 23.
• Blonde L, Merilainen M, Karwe V, Raskin P; TITRATE Study Group. Patient-directed titration for achieving glycaemic goals using a once-daily basal insulin analogue: an assessment of two different fasting plasma glucose targets - the TITRATE study. Diabetes Obes Metab. 2009 Jun;11(6):623-31. doi: 10.1111/j.1463-1326.2009.01060.x.
• Davies M, Lavalle-González F, Storms F, Gomis R; AT.LANTUS Study Group. Initiation of insulin glargine therapy in type 2 diabetes subjects suboptimally controlled on oral antidiabetic agents: results from the AT.LANTUS trial. Diabetes Obes Metab. 2008 May;10(5):387-99. doi: 10.1111/j.1463-1326.2008.00873.x. Epub 2008 Mar 18.
• Davies M, Storms F, Shutler S, Bianchi-Biscay M, Gomis R; ATLANTUS Study Group. Improvement of glycemic control in subjects with poorly controlled type 2 diabetes: comparison of two treatment algorithms using insulin glargine. Diabetes Care. 2005 Jun;28(6):1282-8.
• Riddle MC, Rosenstock J, Gerich J; Insulin Glargine 4002 Study Investigators. The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care. 2003 Nov;26(11):3080-6.
• Walker EA, Shmukler C, Ullman R, Blanco E, Scollan-Koliopoulus M, Cohen HW. Results of a successful telephonic intervention to improve diabetes control in urban adults: a randomized trial. Diabetes Care. 2011 Jan;34(1):2-7. doi: 10.2337/dc10-1005.

• Responsible Party: Natalie Levy, Assistant Professor of Medicine, NYU Langone Health
• ClinicalTrials.gov Identifier: NCT01879579
• Other Study ID Numbers: S12-03713; UL1TR000038
• First Posted: Jun 18, 2013
• Last Update Posted: Oct 12, 2015
• Last Verified: Sep 1, 2015

• Keywords provided by Natalie Levy, Assistant Professor of Medicine, NYU Langone Health: Insulin; Telemedicine
• Additional relevant MeSH terms: Insulin

Study Results

Participant Flow

Arm/Group Title	Mobile Insulin Titration Intervention	Current Best Practice
Arm/Group Description	Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse. Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.	Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
Period Title: Overall Study
STARTED	33	28
COMPLETED	28	26
NOT COMPLETED	5	2

Baseline Characteristics

Arm/Group Title	Mobile Insulin Titration Intervention	Current Best Practice	Total
Arm/Group Description	Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse. Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.	Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.	Total of all reporting groups
Overall Participants	33	28	61
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.48 (11.22)	44.61 (9.97)	46.70 (10.75)
Sex: Female, Male (Count of Participants)
Female	15 45.5%	16 57.1%	31 50.8%
Male	18 54.5%	12 42.9%	30 49.2%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

No primary outcome data available for one participant in Current Best Practice arm who discontinued insulin early due to a mild possible allergy.

Arm/Group Title	Mobile Insulin Titration Intervention	Current Best Practice
Arm/Group Description	Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse. Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.	Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
Measure Participants	33	27
Number [percentage of participants]	88 266.7%	37 132.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mobile Insulin Titration Intervention, Current Best Practice
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	Time to Reach Optimal Long-acting Insulin Dose
Description	The time it takes a patient to reach his/her optimal long-acting insulin dose will be measured for both study arms.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Participants who reached optimal long-acting insulin dose.

Arm/Group Title	Mobile Insulin Titration Intervention	Current Best Practice
Arm/Group Description	Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse. Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.	Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
Measure Participants	29	10
Median (Inter-Quartile Range) [weeks]	3.00	7.07

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mobile Insulin Titration Intervention, Current Best Practice
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	Interval-censoring survival analysis
	Comments

3. Secondary Outcome

Title	Hemoglobin A1c
Description	Change in hemoglobin A1c
Time Frame	baseline, 12 weeks (approximately 3 months)

Outcome Measure Data

Analysis Population Description

All participants with hemoglobin A1c measurements recorded at baseline and 12 weeks.

Arm/Group Title	Mobile Insulin Titration Intervention	Current Best Practice
Arm/Group Description	Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse. Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.	Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
Measure Participants	28	14
Mean (Standard Deviation) [mg/dL]	-1.90 (2.64)	-1.81 (2.63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mobile Insulin Titration Intervention, Current Best Practice
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.99
	Comments
	Method	Wilcoxon rank-sum test
	Comments

4. Secondary Outcome

Title	Baseline Treatment Satisfaction
Description	The Diabetes Treatment Satisfaction Questionnaire standard (DTSQs) will be used to measure the patient's satisfaction with diabetes treatment received prior to study participation. Scores on questionnaire range from 0 to 6: 0 = very dissatisfied, 6 = very satisfied.
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

All participants who completed the treatment satisfaction questionnaire at baseline.

Arm/Group Title	Mobile Insulin Titration Intervention	Current Best Practice
Arm/Group Description	Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse. Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.	Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
Measure Participants	32	28
Mean (Standard Deviation) [score on satisfaction scale]	4.99 (1.14)	5.20 (0.61)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mobile Insulin Titration Intervention, Current Best Practice
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.78
	Comments
	Method	Wilcoxon rank-sum test
	Comments

5. Secondary Outcome

Title	Treatment Satisfaction After Initiation of Insulin Titration
Description	The Diabetes Treatment Satisfaction Questionnaire standard (DTSQs) will be used to measure the patient's satisfaction with diabetes treatment received since initiation of long-acting insulin titration. Scores on questionnaire range from 0 to 6: 0 = very dissatisfied, 6 = very satisfied.
Time Frame	12 weeks (approximately 3 months)

Outcome Measure Data

Analysis Population Description

All participants who completed the treatment satisfaction questionnaire at 12 weeks.

Arm/Group Title	Mobile Insulin Titration Intervention	Current Best Practice
Arm/Group Description	Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse. Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.	Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
Measure Participants	27	22
Mean (Standard Deviation) [score on satisfaction scale]	5.74 (0.54)	5.53 (0.52)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mobile Insulin Titration Intervention, Current Best Practice
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	Wilcoxon rank-sum test
	Comments

6. Secondary Outcome

Title	Change in Treatment Satisfaction
Description	The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) will be used to measure the change in the patient's satisfaction with his/her diabetes treatment since initiation of long-acting insulin titration. Scores on questionnaire range from -3 to +3: -3 = much less satisfied now, +3 = much more satisfied now.
Time Frame	12 weeks (approximately 3 months)

Outcome Measure Data

Analysis Population Description

All participants who completed the treatment satisfaction questionnaire at 12 weeks.

Arm/Group Title	Mobile Insulin Titration Intervention	Current Best Practice
Arm/Group Description	Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse. Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.	Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
Measure Participants	27	22
Mean (Standard Deviation) [score on satisfaction scale]	2.71 (0.71)	2.42 (0.95)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mobile Insulin Titration Intervention, Current Best Practice
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.13
	Comments
	Method	Wilcoxon rank-sum test
	Comments

7. Secondary Outcome

Title	Incidence of Hypoglycemia
Description	The number of instances of hypoglycemia as indicated by fasting blood glucose levels or symptoms reported by patients in both study arms.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

This outcome was analyzed for participants who completed the allocated intervention (and the participant who discontinued insulin early due to a mild possible allergy). Five participants reported hypoglycemia: 3 in the MITI arm and 2 in the CBP arm. All cases were mild.

Arm/Group Title	Mobile Insulin Titration Intervention	Current Best Practice
Arm/Group Description	Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse. Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.	Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
Measure Participants	28	27
Number [instances of hypoglycemia]	5	3

8. Other Pre-specified Outcome

Title	Percentage of Text Message Responses
Description	The number of text message replies from participants compared to the total number of text messages sent to participants (asking for blood glucose values). This outcome is given as a percent.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Participants who completed the allocated intervention.

Arm/Group Title	Mobile Insulin Titration Intervention
Arm/Group Description	Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse. Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.
Measure Participants	28
Measure text messages sent to participants	498
Number [percentage of text messages]	84

9. Other Pre-specified Outcome

Title	Percentage of Successful Phone Calls
Description	The number of successful insulin titration phone calls compared to the total number of insulin titration phone calls assigned to the nurse. Successful phone calls are defined as when the nurse was able to reach the participant with one call attempt, two call attempts, or by voicemail. This outcome is given as a percent.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Participants who completed the allocated intervention.

Arm/Group Title	Mobile Insulin Titration Intervention
Arm/Group Description	Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse. Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.
Measure Participants	28
Measure titration phone calls assigned to nurse	99
Number [percentage of phone calls]	91

10. Other Pre-specified Outcome

Title	Patient Healthcare Utilization
Description	The number of medication refill, emergency department, and walk-in clinic visits at Bellevue Hospital (non-insulin titration visits).
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

All participants.

Arm/Group Title	Mobile Insulin Titration Intervention	Current Best Practice
Arm/Group Description	Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse. Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.	Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
Measure Participants	33	28
Number [hospital visits]	6	11

11. Other Pre-specified Outcome

Title	Costs - Provider Time Spent on Insulin Titration Visits
Description	Provider time spent on insulin titration visits by phone compared to insulin titration visits in the clinic.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Insulin titration visits with a duration recorded.

Arm/Group Title	Insulin Titration Visits by Phone	Insulin Titration Visits in the Clinic
Arm/Group Description	Insulin titration visits that occurred over the phone in both study arms (MITI and CBP arms).	Insulin titration visits that occurred in the clinic in both study arms (MITI and CBP arms).
Measure Participants	28	42
Measure type of insulin titration visit	97	76
Median (Inter-Quartile Range) [minutes]	6	30

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mobile Insulin Titration Intervention, Current Best Practice
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.008
	Comments
	Method	Generalized estimating equation modeling
	Comments

12. Other Pre-specified Outcome

Title	Costs - Titration Visit Information
Description	The number of insulin titration visits (whether by phone or in the clinic).
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Participants who completed the allocated intervention (and the participant who discontinued insulin early).

Arm/Group Title	Mobile Insulin Titration Intervention	Current Best Practice
Arm/Group Description	Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse. Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.	Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
Measure Participants	28	27
Median (Inter-Quartile Range) [insulin titration visits]	3.5	2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mobile Insulin Titration Intervention, Current Best Practice
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Wilcoxon rank-sum test
	Comments

13. Other Pre-specified Outcome

Title	Costs - Patient Travel Time
Description	The time it took patients to travel to Bellevue Hospital, reported by patients in both study arms at baseline and at any subsequent clinic visits.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Participants
Arm/Group Description	Participants in both study arms (MITI and CBP).
Measure Participants	61
Median (Inter-Quartile Range) [minutes]	45

14. Other Pre-specified Outcome

Title	Costs - Co-pays
Description	At baseline, participants in both study arms (MITI and CBP) reported whether they had to pay co-pays for clinic visits at Bellevue Hospital.
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Participants
Arm/Group Description	Participants in both study arms (MITI and CBP).
Measure Participants	61
Number [participants]	37 112.1%

15. Other Pre-specified Outcome

Title	Qualitative Patient Satisfaction Interview
Description	The study staff will interview MITI arm patients, using free-response questions, to assess their satisfaction with the intervention. The interviews will take place in person or over the phone at the patient's convenience, after the patient has reached his/her optimal insulin dose. If the patient does not reach optimal insulin dose, the interview will take place at approximately 12 weeks.
Time Frame	After patient reaches optimal insulin dose or at 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Adverse Event Reporting Description	We were able to assess serious adverse events for participants who completed the allocated intervention (and the participant who discontinued insulin early due to a mild possible allergy). No serious adverse events were found.
Arm/Group Title	Mobile Insulin Titration Intervention		Current Best Practice
Arm/Group Description	Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse. Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.		Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
All Cause Mortality
	Mobile Insulin Titration Intervention		Current Best Practice
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Mobile Insulin Titration Intervention		Current Best Practice
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/27 (0%)
Other (Not Including Serious) Adverse Events
	Mobile Insulin Titration Intervention		Current Best Practice
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/28 (10.7%)		3/27 (11.1%)
General disorders
mild hypoglycemia	3/28 (10.7%)		2/27 (7.4%)
mild possible allergy to insulin	0/28 (0%)		1/27 (3.7%)

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.