Mobile Insulin Titration Intervention (MITI)
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| ClinicalTrials.gov Identifier: NCT01879579 |
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Recruitment Status :
Completed
First Posted : June 18, 2013
Results First Posted : October 12, 2015
Last Update Posted : October 12, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Mellitus | Other: Mobile Insulin Titration Intervention | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| 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 : | June 2013 |
| Actual Primary Completion Date : | March 2015 |
| Actual Study Completion Date : | June 2015 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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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.
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- Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose [ Time Frame: 12 weeks ]
- Time to Reach Optimal Long-acting Insulin Dose [ Time Frame: 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 [ Time Frame: baseline, 12 weeks (approximately 3 months) ]Change in hemoglobin A1c
- Baseline Treatment Satisfaction [ Time Frame: 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.
- Treatment Satisfaction After Initiation of Insulin Titration [ Time Frame: 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.
- Change in Treatment Satisfaction [ Time Frame: 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.
- Incidence of Hypoglycemia [ Time Frame: 12 weeks ]The number of instances of hypoglycemia as indicated by fasting blood glucose levels or symptoms reported by patients in both study arms.
- Percentage of Text Message Responses [ Time Frame: 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.
- Percentage of Successful Phone Calls [ Time Frame: 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.
- Patient Healthcare Utilization [ Time Frame: 12 weeks ]The number of medication refill, emergency department, and walk-in clinic visits at Bellevue Hospital (non-insulin titration visits).
- Costs - Provider Time Spent on Insulin Titration Visits [ Time Frame: 12 weeks ]Provider time spent on insulin titration visits by phone compared to insulin titration visits in the clinic.
- Costs - Titration Visit Information [ Time Frame: 12 weeks ]The number of insulin titration visits (whether by phone or in the clinic).
- Costs - Patient Travel Time [ Time Frame: 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.
- Costs - Co-pays [ Time Frame: 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.
- Qualitative Patient Satisfaction Interview [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01879579
| United States, New York | |
| Adult Primary Care Clinic, Bellevue Hospital Center | |
| New York, New York, United States, 10016 | |
| Principal Investigator: | Natalie Levy, MD | NYU Langone Health |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Natalie Levy, Assistant Professor of Medicine, NYU Langone Health |
| ClinicalTrials.gov Identifier: | NCT01879579 |
| Other Study ID Numbers: |
S12-03713 UL1TR000038 ( U.S. NIH Grant/Contract ) |
| First Posted: | June 18, 2013 Key Record Dates |
| Results First Posted: | October 12, 2015 |
| Last Update Posted: | October 12, 2015 |
| Last Verified: | September 2015 |
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