My Dose Coach Titration and Maintenance in Patients With Type 2 Diabetes Mellitus on Basal Insulin
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus Type 2 - Insulin-Treated
- Sponsor
- Linda Siminerio
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Glycemic Control at 3 Months
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Linda Siminerio
Professor of Medicine
University of Pittsburgh
Eligibility Criteria
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
Exclusion Criteria
- •Pregnant or breastfeeding
- •Patients unwilling to use MDC app
Outcomes
Primary Outcomes
Change From Baseline in Glycemic Control at 3 Months
Time Frame: Baseline to 3 months
Average change in hemoglobin A1c from baseline to 3 months
Secondary Outcomes
- Change From Baseline in Diabetes Distress at 6 Months(Baseline to 6 months)
- Change From 3 Months in Fasting Blood Glucose at 6 Months(Months 3 to 6)
- Change From 3 Months in Diabetes Distress at 6 Months(Month 3 to month 6)
- Participant Satisfaction With Insulin Treatment(6 months)
- Change From Baseline in Fasting Blood Glucose at 6 Months(Baseline to 6 months)
- Proportion of Patients Who Achieve Glycemic Targets(3 months)
- Change From Baseline in Diabetes Distress at 3 Months(Baseline to 3 months)
- Participant Acceptability of Insulin Dosing Support System for Insulin Titration(3 months)
- Change From Baseline in Fasting Blood Glucose at 3 Months(Baseline to 3 months)
- Proportion of Patients Who Maintain Glycemic Targets(6 months)
- Number of Hypoglycemic Events(As reported across study period, up to 6 months)
- Change From Baseline in Hemoglobin A1c at 6 Months(Baseline to 6 months)
- Change From 3 Months in Hemoglobin A1c at 6 Months(Months 3 to 6)
- Number of Participants Who Experienced Severe Hypoglycemic Events.(As reported across study period, up to 6 months)