Mobile Insulin Titration Intervention

Diabetes Mellitus Clinical Trial

— MITI  

Official title:

The Mobile Insulin Titration Intervention (MITI) Study: Innovative Chronic Disease Management of Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01879579
• Other study ID #: S12-03713
• Secondary ID: UL1TR000038
• Status: Completed
• Phase: N/A
• First received: June 13, 2013
• Last updated: September 15, 2015
• Start date: June 2013
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	Adult Primary Care Clinic, Bellevue Hospital Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	New York City Health and Hospitals Corporation

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Text Message Responses	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.	12 weeks	No
Other	Percentage of Successful Phone Calls	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.	12 weeks	No
Other	Patient Healthcare Utilization	The number of medication refill, emergency department, and walk-in clinic visits at Bellevue Hospital (non-insulin titration visits).	12 weeks	No
Other	Costs - Provider Time Spent on Insulin Titration Visits	Provider time spent on insulin titration visits by phone compared to insulin titration visits in the clinic.	12 weeks	No
Other	Costs - Titration Visit Information	The number of insulin titration visits (whether by phone or in the clinic).	12 weeks	No
Other	Costs - Patient Travel Time	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.	12 weeks	No
Other	Costs - Co-pays	At baseline, participants in both study arms (MITI and CBP) reported whether they had to pay co-pays for clinic visits at Bellevue Hospital.	baseline	No
Other	Qualitative Patient Satisfaction Interview	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.	After patient reaches optimal insulin dose or at 12 weeks	No
Primary	Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose		12 weeks	No
Secondary	Time to Reach Optimal Long-acting Insulin Dose	The time it takes a patient to reach his/her optimal long-acting insulin dose will be measured for both study arms.	12 weeks	No
Secondary	Hemoglobin A1c	Change in hemoglobin A1c	baseline, 12 weeks (approximately 3 months)	No
Secondary	Baseline Treatment Satisfaction	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.	baseline	No
Secondary	Treatment Satisfaction After Initiation of Insulin Titration	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.	12 weeks (approximately 3 months)	No
Secondary	Change in Treatment Satisfaction	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.	12 weeks (approximately 3 months)	No
Secondary	Incidence of Hypoglycemia	The number of instances of hypoglycemia as indicated by fasting blood glucose levels or symptoms reported by patients in both study arms.	12 weeks	No