An interventional study of Mobile Insulin Titration Intervention in Diabetes Mellitus, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-10-12.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 61 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
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
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.
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.
Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose
Time frame: 12 weeks
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.
Time frame: 12 weeks
Hemoglobin A1c
Change in hemoglobin A1c
Time frame: baseline, 12 weeks (approximately 3 months)
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.
Time frame: baseline
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.
Time frame: 12 weeks (approximately 3 months)
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.
Time frame: 12 weeks (approximately 3 months)
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
Patient Healthcare Utilization
The number of medication refill, emergency department, and walk-in clinic visits at Bellevue Hospital (non-insulin titration visits).
Time frame: 12 weeks
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.
Time frame: 12 weeks
Costs - Titration Visit Information
The number of insulin titration visits (whether by phone or in the clinic).
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: baseline
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.
Time frame: After patient reaches optimal insulin dose or at 12 weeks
| Milestone | Mobile Insulin Titration Intervention | Current Best Practice |
|---|---|---|
| Started | 33 | 28 |
| Completed | 28 | 26 |
| Not completed | 5 | 2 |
| Withdrew: Phone incompatible with texting platform | 3 | 0 |
| Withdrew: Did not enroll in texting platform | 1 | 0 |
| Withdrew: Did not initiate insulin treatment | 1 | 0 |
| Withdrew: Phenotypic type 1 diabetes | 0 | 1 |
| Withdrew: Discontinued insulin - possible allergy | 0 | 1 |
| percentage of participants | Mobile Insulin Titration Intervention | Current Best Practice |
|---|---|---|
| Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose | 88 | 37 |
The time it takes a patient to reach his/her optimal long-acting insulin dose will be measured for both study arms.
| weeks | Mobile Insulin Titration Intervention | Current Best Practice |
|---|---|---|
| Time to Reach Optimal Long-acting Insulin Dose | 3.00 (1.29 to 4.86) | 7.07 (2.96 to 9.61) |
Change in hemoglobin A1c
| mg/dL | Mobile Insulin Titration Intervention | Current Best Practice |
|---|---|---|
| Hemoglobin A1c | -1.90 ± 2.64 | -1.81 ± 2.63 |
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.
| score on satisfaction scale | Mobile Insulin Titration Intervention | Current Best Practice |
|---|---|---|
| Baseline Treatment Satisfaction | 4.99 ± 1.14 | 5.20 ± 0.61 |
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.
| score on satisfaction scale | Mobile Insulin Titration Intervention | Current Best Practice |
|---|---|---|
| Treatment Satisfaction After Initiation of Insulin Titration | 5.74 ± 0.54 | 5.53 ± 0.52 |
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.
| score on satisfaction scale | Mobile Insulin Titration Intervention | Current Best Practice |
|---|---|---|
| Change in Treatment Satisfaction | 2.71 ± 0.71 | 2.42 ± 0.95 |
The number of instances of hypoglycemia as indicated by fasting blood glucose levels or symptoms reported by patients in both study arms.
| instances of hypoglycemia | Mobile Insulin Titration Intervention | Current Best Practice |
|---|---|---|
| Incidence of Hypoglycemia | 5 | 3 |
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 text messages | Mobile Insulin Titration Intervention |
|---|---|
| Percentage of Text Message Responses | 84 |
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.
| percentage of phone calls | Mobile Insulin Titration Intervention |
|---|---|
| Percentage of Successful Phone Calls | 91 |
The number of medication refill, emergency department, and walk-in clinic visits at Bellevue Hospital (non-insulin titration visits).
| hospital visits | Mobile Insulin Titration Intervention | Current Best Practice |
|---|---|---|
| Patient Healthcare Utilization | 6 | 11 |
Provider time spent on insulin titration visits by phone compared to insulin titration visits in the clinic.
| minutes | Insulin Titration Visits by Phone | Insulin Titration Visits in the Clinic |
|---|---|---|
| Costs - Provider Time Spent on Insulin Titration Visits | 6 (3 to 10) | 30 (20 to 45) |
The number of insulin titration visits (whether by phone or in the clinic).
| insulin titration visits | Mobile Insulin Titration Intervention | Current Best Practice |
|---|---|---|
| Costs - Titration Visit Information | 3.5 (2 to 5) | 2 (1 to 3) |
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.
| minutes | All Participants |
|---|---|
| Costs - Patient Travel Time | 45 (30 to 60) |
At baseline, participants in both study arms (MITI and CBP) reported whether they had to pay co-pays for clinic visits at Bellevue Hospital.
| participants | All Participants |
|---|---|
| Costs - Co-pays | 37 |
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.
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mobile Insulin Titration Intervention | — | 0/28 (0%) | 3/28 (10.7%) |
| Current Best Practice | — | 0/27 (0%) | 3/27 (11.1%) |
| Event | Mobile Insulin Titration Intervention | Current Best Practice |
|---|---|---|
| mild hypoglycemiaGeneral disorders | 3/28 | 2/27 |
| mild possible allergy to insulinGeneral disorders | 0/28 | 1/27 |
| Age, Continuous(years) | Mobile Insulin Titration Intervention | Current Best Practice | Total |
|---|---|---|---|
| Mean | 48.48 ± 11.22 | 44.61 ± 9.97 | 46.70 ± 10.75 |
| Sex: Female, Male(Participants) | Mobile Insulin Titration Intervention | Current Best Practice | Total |
|---|---|---|---|
| Female | 15 | 16 | 31 |
| Male | 18 | 12 | 30 |
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