Clinical trial NCT04678661: My Dose Coach Mobile App to Support Insulin Titration and Maintenance
Official title: My Dose Coach Titration and Maintenance in Patients With Type 2 Diabetes Mellitus on Basal Insulin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus Type 2 - Insulin-Treated
Keywords: Mobile application
Digital titration
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2020-12-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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
* 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

Primary outcomes:
measure: Change From Baseline in Glycemic Control at 3 Months
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Change From Baseline in Fasting Blood Glucose at 3 Months
timeFrame: Baseline to 3 months
measure: Change From Baseline in Fasting Blood Glucose at 6 Months
timeFrame: Baseline to 6 months
measure: Change From 3 Months in Fasting Blood Glucose at 6 Months
timeFrame: Months 3 to 6
measure: Change From Baseline in Hemoglobin A1c at 6 Months
timeFrame: Baseline to 6 months
measure: Change From 3 Months in Hemoglobin A1c at 6 Months
timeFrame: Months 3 to 6
measure: Proportion of Patients Who Achieve Glycemic Targets
timeFrame: 3 months
measure: Proportion of Patients Who Maintain Glycemic Targets
timeFrame: 6 months
measure: Change From Baseline in Diabetes Distress at 3 Months
timeFrame: Baseline to 3 months
measure: Change From Baseline in Diabetes Distress at 6 Months
timeFrame: Baseline to 6 months
measure: Change From 3 Months in Diabetes Distress at 6 Months
timeFrame: Month 3 to month 6
measure: Participant Acceptability of Insulin Dosing Support System for Insulin Titration
timeFrame: 3 months
measure: Participant Satisfaction With Insulin Treatment
timeFrame: 6 months
measure: Number of Hypoglycemic Events
timeFrame: As reported across study period, up to 6 months
measure: Number of Participants Who Experienced Severe Hypoglycemic Events.
timeFrame: As reported across study period, up to 6 months
Other outcomes:
measure: Participant Use of My Dose Coach
timeFrame: As reported across study period, up to 6 months
measure: Number of Technical Complaints
timeFrame: As reported across study period, up to 6 months
measure: Frequency of Escalation of Care
timeFrame: As reported across study period, up to 6 months
measure: Type of Technical Complaints
timeFrame: As reported across study period, up to 6 months
measure: Type of Escalation of Care
timeFrame: As reported across study period, up to 6 months
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Professor
name: Linda Siminerio, RN, PhD, CDE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626.
citation: Fisher L, Hessler DM, Polonsky WH, Mullan J. When is diabetes distress clinically meaningful?: establishing cut points for the Diabetes Distress Scale. Diabetes Care. 2012 Feb;35(2):259-64. doi: 10.2337/dc11-1572. Epub 2012 Jan 6.
citation: Peyrot M, Xu Y, Rubin RR. Development and validation of the Diabetes Medication System Rating Questionnaire-Short Form. Diabet Med. 2014 Oct;31(10):1237-44. doi: 10.1111/dme.12453. Epub 2014 Apr 18.