Trial Outcomes & Findings for Mobile Insulin Titration Intervention (NCT NCT01879579)

NCT ID: NCT01879579

Last Updated: 2015-10-12

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 61 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2015-10-12

Participant Flow

Participant milestones

Measure	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. 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.	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.
Overall Study STARTED	33	28
Overall Study COMPLETED	28	26
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Measure	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. 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.	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.
Overall Study Phone incompatible with texting platform	3	0
Overall Study Did not enroll in texting platform	1	0
Overall Study Did not initiate insulin treatment	1	0
Overall Study Phenotypic type 1 diabetes	0	1
Overall Study Discontinued insulin - possible allergy	0	1

Baseline Characteristics

Mobile Insulin Titration Intervention

Baseline characteristics by cohort

Measure	Mobile Insulin Titration Intervention n=33 Participants 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. 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.	Current Best Practice n=28 Participants 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.	Total n=61 Participants Total of all reporting groups
Age, Continuous	48.48 years STANDARD_DEVIATION 11.22 • n=5 Participants	44.61 years STANDARD_DEVIATION 9.97 • n=7 Participants	46.70 years STANDARD_DEVIATION 10.75 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	12 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: No primary outcome data available for one participant in Current Best Practice arm who discontinued insulin early due to a mild possible allergy.

Outcome measures

Measure	Mobile Insulin Titration Intervention n=33 Participants 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. 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.	Current Best Practice n=27 Participants 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.
Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose	88 percentage of participants	37 percentage of participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Participants who reached 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.

Outcome measures

Measure	Mobile Insulin Titration Intervention n=29 Participants 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. 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.	Current Best Practice n=10 Participants 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.
Time to Reach Optimal Long-acting Insulin Dose	3.00 weeks Interval 1.29 to 4.86	7.07 weeks Interval 2.96 to 9.61

SECONDARY outcome

Timeframe: baseline, 12 weeks (approximately 3 months)

Population: All participants with hemoglobin A1c measurements recorded at baseline and 12 weeks.

Change in hemoglobin A1c

Outcome measures

Measure	Mobile Insulin Titration Intervention n=28 Participants 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. 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.	Current Best Practice n=14 Participants 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.
Hemoglobin A1c	-1.90 mg/dL Standard Deviation 2.64	-1.81 mg/dL Standard Deviation 2.63

SECONDARY outcome

Timeframe: baseline

Population: All participants who completed the treatment satisfaction questionnaire at 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.

Outcome measures

Measure	Mobile Insulin Titration Intervention n=32 Participants 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. 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.	Current Best Practice n=28 Participants 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.
Baseline Treatment Satisfaction	4.99 score on satisfaction scale Standard Deviation 1.14	5.20 score on satisfaction scale Standard Deviation 0.61

SECONDARY outcome

Timeframe: 12 weeks (approximately 3 months)

Population: All participants who completed the treatment satisfaction questionnaire at 12 weeks.

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.

Outcome measures

Measure	Mobile Insulin Titration Intervention n=27 Participants 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. 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.	Current Best Practice n=22 Participants 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.
Treatment Satisfaction After Initiation of Insulin Titration	5.74 score on satisfaction scale Standard Deviation 0.54	5.53 score on satisfaction scale Standard Deviation 0.52

SECONDARY outcome

Timeframe: 12 weeks (approximately 3 months)

Population: All participants who completed the treatment satisfaction questionnaire at 12 weeks.

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.

Outcome measures

Measure	Mobile Insulin Titration Intervention n=27 Participants 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. 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.	Current Best Practice n=22 Participants 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.
Change in Treatment Satisfaction	2.71 score on satisfaction scale Standard Deviation 0.71	2.42 score on satisfaction scale Standard Deviation 0.95

SECONDARY outcome

Timeframe: 12 weeks

Population: This outcome was analyzed for participants who completed the allocated intervention (and the participant who discontinued insulin early due to a mild possible allergy). Five participants reported hypoglycemia: 3 in the MITI arm and 2 in the CBP arm. All cases were mild.

The number of instances of hypoglycemia as indicated by fasting blood glucose levels or symptoms reported by patients in both study arms.

Outcome measures

Measure	Mobile Insulin Titration Intervention n=28 Participants 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. 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.	Current Best Practice n=27 Participants 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.
Incidence of Hypoglycemia	5 instances of hypoglycemia	3 instances of hypoglycemia

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Population: Participants who completed the allocated intervention.

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.

Outcome measures

Measure	Mobile Insulin Titration Intervention n=498 text messages sent to participants 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. 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.	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.
Percentage of Text Message Responses	84 percentage of text messages	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Population: Participants who completed the allocated intervention.

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.

Outcome measures

Measure	Mobile Insulin Titration Intervention n=99 titration phone calls assigned to nurse 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. 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.	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.
Percentage of Successful Phone Calls	91 percentage of phone calls	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Population: All participants.

The number of medication refill, emergency department, and walk-in clinic visits at Bellevue Hospital (non-insulin titration visits).

Outcome measures

Measure	Mobile Insulin Titration Intervention n=33 Participants 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. 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.	Current Best Practice n=28 Participants 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.
Patient Healthcare Utilization	6 hospital visits	11 hospital visits

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Population: Insulin titration visits with a duration recorded.

Provider time spent on insulin titration visits by phone compared to insulin titration visits in the clinic.

Outcome measures

Measure	Mobile Insulin Titration Intervention n=97 type of insulin titration visit 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. 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.	Current Best Practice n=76 type of insulin titration visit 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.
Costs - Provider Time Spent on Insulin Titration Visits	6 minutes Interval 3.0 to 10.0	30 minutes Interval 20.0 to 45.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Population: Participants who completed the allocated intervention (and the participant who discontinued insulin early).

The number of insulin titration visits (whether by phone or in the clinic).

Outcome measures

Measure	Mobile Insulin Titration Intervention n=28 Participants 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. 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.	Current Best Practice n=27 Participants 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.
Costs - Titration Visit Information	3.5 insulin titration visits Interval 2.0 to 5.0	2 insulin titration visits Interval 1.0 to 3.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Mobile Insulin Titration Intervention n=61 Participants 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. 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.	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.
Costs - Patient Travel Time	45 minutes Interval 30.0 to 60.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Mobile Insulin Titration Intervention n=61 Participants 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. 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.	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.
Costs - Co-pays	37 participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Mobile Insulin Titration Intervention

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Current Best Practice

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Mobile Insulin Titration Intervention n=28 participants at risk 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. 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.	Current Best Practice n=27 participants at risk 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.
General disorders mild hypoglycemia	10.7% 3/28 We were able to assess serious adverse events for participants who completed the allocated intervention (and the participant who discontinued insulin early due to a mild possible allergy). No serious adverse events were found.	7.4% 2/27 We were able to assess serious adverse events for participants who completed the allocated intervention (and the participant who discontinued insulin early due to a mild possible allergy). No serious adverse events were found.
General disorders mild possible allergy to insulin	0.00% 0/28 We were able to assess serious adverse events for participants who completed the allocated intervention (and the participant who discontinued insulin early due to a mild possible allergy). No serious adverse events were found.	3.7% 1/27 We were able to assess serious adverse events for participants who completed the allocated intervention (and the participant who discontinued insulin early due to a mild possible allergy). No serious adverse events were found.

Additional Information

Dr. Natalie Levy

New York University School of Medicine

Phone: 2122638924

Email: Natalie.Levy@nyumc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place