My Dose Coach Mobile App to Support Insulin Titration and Maintenance

Not Applicable

Terminated

Conditions: Diabetes Mellitus Type 2 - Insulin-Treated

Interventions: Device: Smartphone application and web portal
Behavioral: Standard Insulin Therapy Education

Registration Number: NCT04678661

Lead Sponsor: Linda Siminerio

Brief Summary: The purpose of this research study is to evaluate an electronic application (app) designed to help people with type 2 diabetes (T2DM) adjust their insulin doses. The app is called My Dose Coach. This research study is being done in 2 phases. Specifically in Phase 1, the study is assessing the role of the My Dose Coach app in helping participants make insulin adjustments to get their blood glucoses to the target level that is planned for with the diabetes team, called the dosing or titration phase, when first starting insulin. In Phase 2, the study is assessing the role of the My Dose Coach app in helping participants keep blood glucoses in the target range, called the maintenance phase.

Detailed Description: Despite the increasing body of knowledge of diabetes treatment strategies, a majority of patients with T2DM are still in a persistent state of poor glycemic control and unable to meet target goals. Inertia surrounding insulin initiation and titration is a specific problem. Various approaches have been proposed to help overcome clinical inertia, including support of patient self-management, and education for both physicians and people with diabetes. Presently, paper-based guides are available in which clinicians/educators rely on to help their patients in determining and recording appropriate insulin doses. Unfortunately, this process often sets the stage for reluctance and fear of insulin initiation and delays titration with implications for long-term poor self-management and adherence. Therefore, Sanofi developed the My Dose Coach electronic app to assist with optimizing titration of basal insulins and supporting proper insulin maintenance. The primary objective of this two phase study is to demonstrate that patients who are trained on the My Dose Coach app to titrate insulin will have greater improvements in hemoglobin A1c and will be more likely to achieve glycemic control at three months as compared to usual care practice, and, for the intervention group only, those who do attain glycemic goals will be able to maintain glycemic control for an additional three months. The secondary objective of this study is to examine the feasibility of integrating digital solutions into clinical workflow and user acceptability of My Dose Coach.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 60

Inclusion Criteria

Intervention Group

Patient receiving care at a UPMC Diabetes Outpatient and/or Inpatient settings
Adult male and female patients 18 to 75 years old
HbA1c > 7.5%
Recommended to start self titration of basal insulin
Access to and able to use an iOS (Apple phone operating system) or Android enabled device and have reliable internet access
Willing and able to use the MDC app
Able to comprehend basic diabetes survival skills, signs and symptoms of hypoglycemia and treatment of BG

Usual Care Group

Adult male and female patients 18 to 75 years old
HbA1c > 7.5%
Started on basal insulin in a UPMC Diabetes Outpatient facility within the past three years of study start
Has blood glucose data available in electronic medical records (EMR) (At least two HbA1c measurements corresponding to baseline and a subsequent time point after insulin titration)

Exclusion Criteria

Pregnant or breastfeeding
Patients unwilling to use MDC app

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
My Dose Coach (Insulin Dosing Support App)	Standard Insulin Therapy Education	Phase 1 Titration: Patients receive insulin therapy education from diabetes educator (DE). Plus, DE trains patients to use My Dose Coach (MDC) for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients are asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reach glycemic target are invited to Phase 2. Other patients are invited to continue titrating for another 3 months. Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trains patients the MDC Maintenance Module to support proper insulin dosing. Patients are asked to return for follow-up clinic visits at mo 6. Patients are surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.
Usual Care Group	Standard Insulin Therapy Education	A retrospective comparative group will 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 will be identified using data available in the electronic medical record system. Propensity score matching will be used to pair intervention and usual care participants during phase 1 of the study (baseline to 3 months).
My Dose Coach (Insulin Dosing Support App)	Smartphone application and web portal	Phase 1 Titration: Patients receive insulin therapy education from diabetes educator (DE). Plus, DE trains patients to use My Dose Coach (MDC) for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients are asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reach glycemic target are invited to Phase 2. Other patients are invited to continue titrating for another 3 months. Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trains patients the MDC Maintenance Module to support proper insulin dosing. Patients are asked to return for follow-up clinic visits at mo 6. Patients are surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Glycemic Control at 3 Months	Baseline to 3 months	Average change in hemoglobin A1c from baseline to 3 months

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Diabetes Distress at 6 Months	Baseline to 6 months	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.
Change From 3 Months in Diabetes Distress at 6 Months	Month 3 to month 6	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.
Participant Satisfaction With Insulin Treatment	6 months	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.
Change From Baseline in Fasting Blood Glucose at 6 Months	Baseline to 6 months	Change in fasting blood glucose from baseline to 6 months for the intervention group.
Change From 3 Months in Fasting Blood Glucose at 6 Months	Months 3 to 6	Chang in fasting blood glucose from month 3 to 6 for the intervention group.
Proportion of Patients Who Achieve Glycemic Targets	3 months	Achieving glycemic target defined as reduction in hemoglobin A1c \<7% by 3 months after baseline
Change From Baseline in Diabetes Distress at 3 Months	Baseline to 3 months	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.
Participant Acceptability of Insulin Dosing Support System for Insulin Titration	3 months	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.
Change From Baseline in Fasting Blood Glucose at 3 Months	Baseline to 3 months	Change in fasting blood glucose from baseline to 3 months for the intervention group.
Proportion of Patients Who Maintain Glycemic Targets	6 months	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.
Number of Hypoglycemic Events	As reported across study period, up to 6 months	Total number of hypoglycemic events where blood glucose \<70mg/dl.
Change From Baseline in Hemoglobin A1c at 6 Months	Baseline to 6 months	Average change in hemoglobin A1c from baseline to 6 months for the intervention group.
Change From 3 Months in Hemoglobin A1c at 6 Months	Months 3 to 6	Average change in hemoglobin A1c from 3 months to 6 months for the intervention group.
Number of Participants Who Experienced Severe Hypoglycemic Events.	As reported across study period, up to 6 months	Severe hypoglycemic events were defined a hypoglycemic events that required assistance of another person to resuscitate because blood glucoses are too low to maintain consciousness.