Mobile Insulin Titration Intervention

Not Applicable

Completed

Conditions: Diabetes Mellitus

Interventions: Other: Mobile Insulin Titration Intervention

Registration Number: NCT01879579

Lead Sponsor: NYU Langone Health

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 61

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mobile Insulin Titration Intervention	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose	12 weeks

Secondary Outcome Measures

Name	Time	Method
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.
Hemoglobin A1c	baseline, 12 weeks (approximately 3 months)	Change in hemoglobin A1c
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.
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.
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.
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.