Trial Outcomes & Findings for My Dose Coach Mobile App to Support Insulin Titration and Maintenance (NCT NCT04678661)

Results Overview

Average change in hemoglobin A1c from baseline to 3 months

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Baseline to 3 months

Results posted on

2024-02-14

Participant Flow

Participants were identified at participating community-based primary care practices, diabetes outpatient clinics and hospital inpatient units.

Usual care is a historical comparison group, therefore usual care participants were not considered to be enrolled into the study.

Participant milestones

Participant milestones
Measure	My Dose Coach (Insulin Dosing Support App) Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo. Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo. Patients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.	Usual Care Group A retrospective comparative group was be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group were identified using data available in the electronic medical record system. Propensity score matching were used to pair intervention and usual care participants.
Overall Study STARTED	60	33
Overall Study COMPLETED	36	33
Overall Study NOT COMPLETED	24	0

Reasons for withdrawal

Reasons for withdrawal
Measure	My Dose Coach (Insulin Dosing Support App) Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo. Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo. Patients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.	Usual Care Group A retrospective comparative group was be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group were identified using data available in the electronic medical record system. Propensity score matching were used to pair intervention and usual care participants.
Overall Study Study paused to address technical issues related to the app. Participants removed from study .	17	0
Overall Study Protocol Violation	2	0
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	2	0
Overall Study Death	2	0

Baseline Characteristics

My Dose Coach Mobile App to Support Insulin Titration and Maintenance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=60 Participants Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo. Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo. Patients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.	Usual Care n=33 Participants A retrospective comparative group was be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group were identified using data available in the electronic medical record system. Propensity score matching were used to pair intervention and usual care participants.	Total n=93 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=5 Participants	27 Participants n=7 Participants	73 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	6 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	20 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	13 Participants n=7 Participants	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	55 Participants n=5 Participants	33 Participants n=7 Participants	88 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	52 Participants n=5 Participants	31 Participants n=7 Participants	83 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants	33 participants n=7 Participants	93 participants n=5 Participants
Hemoglobin A1c	9.8 % glycated hemoglobin STANDARD_DEVIATION 1.7 • n=5 Participants	9.7 % glycated hemoglobin STANDARD_DEVIATION 1.4 • n=7 Participants	9.8 % glycated hemoglobin STANDARD_DEVIATION 1.6 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 3 months

Population: Using propensity score matching, 33 intervention participants were paired with 33 usual care participants to compare changes in hemoglobin A1c from baseline to 3 months.

Average change in hemoglobin A1c from baseline to 3 months

Outcome measures

Outcome measures
Measure	Intervention n=33 Participants Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo. Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo. Patients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.	Usual Care n=33 Participants A retrospective comparative group was be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group were identified using data available in the electronic medical record system. Propensity score matching were used to pair intervention and usual care participants.
Change From Baseline in Glycemic Control at 3 Months	-2 % glycated hemoglobin Standard Deviation 2.2	-1.7 % glycated hemoglobin Standard Deviation 1.9

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: Population includes all intervention participants who completed the study and had fasting blood glucose values at both baseline and 3 month timepoints. Fasting blood glucose values were not collected for the historic usual care group so they were not included for analysis.

Change in fasting blood glucose from baseline to 3 months for the intervention group.

Outcome measures

Outcome measures
Measure	Intervention n=31 Participants Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo. Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo. Patients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.	Usual Care A retrospective comparative group was be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group were identified using data available in the electronic medical record system. Propensity score matching were used to pair intervention and usual care participants.
Change From Baseline in Fasting Blood Glucose at 3 Months	-33.4 mg/dL Standard Deviation 68.2	—

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: Participants in the intervention group who completed the study and had fasting blood glucose values recorded at time points of comparison. Data were not collected for the historic usual care group so they were not included for analysis of this outcome.

Change in fasting blood glucose from baseline to 6 months for the intervention group.

Outcome measures

Outcome measures
Measure	Intervention n=25 Participants Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo. Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo. Patients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.	Usual Care A retrospective comparative group was be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group were identified using data available in the electronic medical record system. Propensity score matching were used to pair intervention and usual care participants.
Change From Baseline in Fasting Blood Glucose at 6 Months	-38.3 mg/dl Standard Deviation 79.8	—

SECONDARY outcome

Timeframe: Months 3 to 6

Population: Participants in the intervention group who completed the study and had fasting blood glucose values recorded at time points of comparison. Data were not collected for the historic usual care group so they were not included for analysis of this outcome.

Chang in fasting blood glucose from month 3 to 6 for the intervention group.

Outcome measures

Outcome measures
Measure	Intervention n=23 Participants Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo. Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo. Patients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.	Usual Care A retrospective comparative group was be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group were identified using data available in the electronic medical record system. Propensity score matching were used to pair intervention and usual care participants.
Change From 3 Months in Fasting Blood Glucose at 6 Months	5 mg/dL Standard Deviation 42.6	—

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: All participants in the intervention group with available hemoglobin A1 data at the specified time points were included. Data were not collected for the historic usual care group so they were not included for analysis of this outcome.

Average change in hemoglobin A1c from baseline to 6 months for the intervention group.

Outcome measures

Outcome measures
Measure	Intervention n=34 Participants Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo. Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo. Patients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.	Usual Care A retrospective comparative group was be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group were identified using data available in the electronic medical record system. Propensity score matching were used to pair intervention and usual care participants.
Change From Baseline in Hemoglobin A1c at 6 Months	-2.3 % glycated hemoglobin Standard Deviation 2.3	—

SECONDARY outcome

Timeframe: Months 3 to 6

Population: All participants in the intervention group who had hemoglobin A1c values available at time points of comparison were included. Data were not collected for the historic usual care group so they were not included for analysis for this outcome.

Average change in hemoglobin A1c from 3 months to 6 months for the intervention group.

Outcome measures

Outcome measures
Measure	Intervention n=31 Participants Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo. Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo. Patients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.	Usual Care A retrospective comparative group was be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group were identified using data available in the electronic medical record system. Propensity score matching were used to pair intervention and usual care participants.
Change From 3 Months in Hemoglobin A1c at 6 Months	-.16 % glycated hemoglobin Standard Deviation .8	—

SECONDARY outcome

Timeframe: 3 months

Population: Intervention group includes those participants who completed the study and had 3 month hemoglobin A1c values. Usual care is a historical comparative group.

Achieving glycemic target defined as reduction in hemoglobin A1c \<7% by 3 months after baseline

Outcome measures

Outcome measures
Measure	Intervention n=32 Participants Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo. Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo. Patients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.	Usual Care n=33 Participants A retrospective comparative group was be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group were identified using data available in the electronic medical record system. Propensity score matching were used to pair intervention and usual care participants.
Proportion of Patients Who Achieve Glycemic Targets	.31 proportion of participants	.3 proportion of participants

SECONDARY outcome

Timeframe: 6 months

Population: Participants in the intervention group who reached their target glycemic goal (hemoglobin A1c \<7%) at 3 months and had hemoglobin A1c values available at 6 months. Data were not collected for the historic usual care group so they were not included for analysis for this outcome.

Maintaining glycemic target defined as maintaining a hemoglobin A1c \<7% at 6 months for those who achieved this target at 3 months in the intervention group.

Outcome measures

Outcome measures
Measure	Intervention n=10 Participants Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo. Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo. Patients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.	Usual Care A retrospective comparative group was be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group were identified using data available in the electronic medical record system. Propensity score matching were used to pair intervention and usual care participants.
Proportion of Patients Who Maintain Glycemic Targets	1 proportion of participants	—

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: All participants in the intervention group who completed the study. Data were not collected for the historic usual care group so they were not included for analysis for this outcome.

Diabetes distress was evaluated with the 17-item Diabetes Distress Scale, which assesses four dimensions of distress - emotional, regimen, interpersonal and physician, and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM. Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress. Possible scores range from 1 to 6.

Outcome measures

Outcome measures
Measure	Intervention n=36 Participants Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo. Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo. Patients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.	Usual Care A retrospective comparative group was be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group were identified using data available in the electronic medical record system. Propensity score matching were used to pair intervention and usual care participants.
Change From Baseline in Diabetes Distress at 3 Months	-.47 Score on scale Standard Deviation .55	—

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: All intervention participants who completed the study. Data were not collected for the historic usual care group so they were not included for analysis for this outcome.

Diabetes distress was evaluated with the 17-item Diabetes Distress Scale, which assesses four dimensions of distress - emotional, regimen, interpersonal and physician, and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM. Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress. Possible scores range from 1 to 6.

Outcome measures

Outcome measures
Measure	Intervention n=36 Participants Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo. Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo. Patients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.	Usual Care A retrospective comparative group was be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group were identified using data available in the electronic medical record system. Propensity score matching were used to pair intervention and usual care participants.
Change From Baseline in Diabetes Distress at 6 Months	-.49 Score on scale Standard Deviation .57	—

SECONDARY outcome

Timeframe: Month 3 to month 6

Population: All participants who completed the intervention. Data were not collected for the historic usual care group so they were not included for analysis for this outcome.

Diabetes distress was evaluated with the 17-item Diabetes Distress Scale, which assesses four dimensions of distress - emotional, regimen, interpersonal and physician, and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM. Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress. Possible scores range from 1 to 6.

Outcome measures

Outcome measures
Measure	Intervention n=36 Participants Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo. Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo. Patients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.	Usual Care A retrospective comparative group was be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group were identified using data available in the electronic medical record system. Propensity score matching were used to pair intervention and usual care participants.
Change From 3 Months in Diabetes Distress at 6 Months	-.02 Score on scale Standard Deviation .3	—

SECONDARY outcome

Timeframe: 3 months

Population: All participants in the intervention who completed the study.

Participants rated their acceptability of My Dose Coach using a study-specific survey. Individual items are scored from 1 to 5; total scores are the average of all individual item scores; . Possible score range 1 to 5. The higher the score, the better the rating or acceptability of the insulin dosing support system.

Outcome measures

Outcome measures
Measure	Intervention n=36 Participants Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo. Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo. Patients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.	Usual Care A retrospective comparative group was be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group were identified using data available in the electronic medical record system. Propensity score matching were used to pair intervention and usual care participants.
Participant Acceptability of Insulin Dosing Support System for Insulin Titration	4.6 Score on scale Standard Deviation .7	—

SECONDARY outcome

Timeframe: 6 months

Population: All participants who completed the intervention. Data were not collected for the historic usual care group so they were not included for analysis for this outcome.

The Diabetes Medication Systems Rating Questionnaire-Short Form, was also be used to inform patient acceptability and satisfaction with insulin. This questionnaire includes 20 items to assess convenience, negative events, interference, self-monitoring of blood glucose burden, efficacy, social burden, psychological well-being, treatment satisfaction and treatment preference. All items are scored 0 to 100. Composite score is calculated as means of completed items. Possible score range is 0 to 100. The higher the score, the higher the level of satisfaction.