Clinical trial NCT01879579: Mobile Insulin Titration Intervention
Official title: The Mobile Insulin Titration Intervention (MITI) Study: Innovative Chronic Disease Management of Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Insulin
Telemedicine
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: New York City Health and Hospitals Corporation
First posted: 2013-06-18
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose
timeFrame: 12 weeks
Secondary outcomes:
measure: Time to Reach Optimal Long-acting Insulin Dose
timeFrame: 12 weeks
measure: Hemoglobin A1c
timeFrame: baseline, 12 weeks (approximately 3 months)
measure: Baseline Treatment Satisfaction
timeFrame: baseline
measure: Treatment Satisfaction After Initiation of Insulin Titration
timeFrame: 12 weeks (approximately 3 months)
measure: Change in Treatment Satisfaction
timeFrame: 12 weeks (approximately 3 months)
measure: Incidence of Hypoglycemia
timeFrame: 12 weeks
Other outcomes:
measure: Percentage of Text Message Responses
timeFrame: 12 weeks
measure: Percentage of Successful Phone Calls
timeFrame: 12 weeks
measure: Patient Healthcare Utilization
timeFrame: 12 weeks
measure: Costs - Provider Time Spent on Insulin Titration Visits
timeFrame: 12 weeks
measure: Costs - Titration Visit Information
timeFrame: 12 weeks
measure: Costs - Patient Travel Time
timeFrame: 12 weeks
measure: Costs - Co-pays
timeFrame: baseline
measure: Qualitative Patient Satisfaction Interview
timeFrame: After patient reaches optimal insulin dose or at 12 weeks
Locations:
city: New York
country: United States
facility: Adult Primary Care Clinic, Bellevue Hospital Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Natalie Levy, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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.
citation: Levy N, Moynihan V, Nilo A, Singer K, Bernik LS, Etiebet MA, Fang Y, Cho J, Natarajan S. The Mobile Insulin Titration Intervention (MITI) for Insulin Adjustment in an Urban, Low-Income Population: Randomized Controlled Trial. J Med Internet Res. 2015 Jul 17;17(7):e180. doi: 10.2196/jmir.4716.
citation: Levy N, Moynihan V, Nilo A, Singer K, Bernik LS, Etiebet MA, Fang Y, Cho J, Natarajan S. The Mobile Insulin Titration Intervention (MITI) for Insulin Glargine Titration in an Urban, Low-Income Population: Randomized Controlled Trial Protocol. JMIR Res Protoc. 2015 Mar 13;4(1):e31. doi: 10.2196/resprot.4206.