My Dose Coach Mobile App to Support Insulin Titration and Maintenance

My Dose Coach Titration and Maintenance in Patients With Type 2 Diabetes Mellitus on Basal Insulin

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.

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus Type 2 - Insulin-Treated
• Intervention / Treatment: Device: Smartphone application and web portal; Behavioral: Standard Insulin Therapy Education

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: My Dose Coach (Insulin Dosing Support App); 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.	Device: Smartphone application and web portal; My Dose Coach is indicated for single patient use outside the clinic setting by a previously diagnosed Type 2 Diabetic who has been prescribed a once-daily long-acting basal insulin. MDC is intended as an aid to the patient to provide dose suggestions based upon the HCP's independent professional judgment. Before My Dose Coach can be used, the HCP configures the dose instructions for the specific patient and activates the application using the specific patient Instructions. The application uses the dose plan instructions provided by the patient's HCP to provide dose suggestions of once-daily long-acting basal insulin (i.e. basal insulin titration) that are based on the patient's Fasting Blood Glucose (FBG) as well as hypoglycemia occurrence. MDC includes a Maintenance Module designed to support patients in maintaining proper insulin dosingby enabling logging of administered doses of prescribed diabetes medications and BGM and providing dosing and measurement reminders.; Other Names: My Dose Coach; Behavioral: Standard Insulin Therapy Education; Standard best practices for training patients to administer insulin therapy include 1) a thorough patient assessment prior to therapy initiation to address barriers, including evaluation for diminished cognitive capacity or other problem that may impair safe insulin self-administration, and assessment of health literacy and numeracy skills; 2) observation of a patient's injection practice, with re-education provided as needed; 3) use of appropriate language is necessary when teaching injection technique; 4) dose preparation, which includes inspecting the insulin dose for accuracy (following manufacturer instructions); and 5) review of signs, symptoms and treatment of hypoglycemia must be included as a critical component of the training.
Active Comparator: Usual Care Group; 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).	Behavioral: Standard Insulin Therapy Education; Standard best practices for training patients to administer insulin therapy include 1) a thorough patient assessment prior to therapy initiation to address barriers, including evaluation for diminished cognitive capacity or other problem that may impair safe insulin self-administration, and assessment of health literacy and numeracy skills; 2) observation of a patient's injection practice, with re-education provided as needed; 3) use of appropriate language is necessary when teaching injection technique; 4) dose preparation, which includes inspecting the insulin dose for accuracy (following manufacturer instructions); and 5) review of signs, symptoms and treatment of hypoglycemia must be included as a critical component of the training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Glycemic Control at 3 Months	Average change in hemoglobin A1c from baseline to 3 months	Baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Fasting Blood Glucose at 3 Months	Change in fasting blood glucose from baseline to 3 months for the intervention group.	Baseline to 3 months
Change From Baseline in Fasting Blood Glucose at 6 Months	Change in fasting blood glucose from baseline to 6 months for the intervention group.	Baseline to 6 months
Change From 3 Months in Fasting Blood Glucose at 6 Months	Chang in fasting blood glucose from month 3 to 6 for the intervention group.	Months 3 to 6
Change From Baseline in Hemoglobin A1c at 6 Months	Average change in hemoglobin A1c from baseline to 6 months for the intervention group.	Baseline to 6 months
Change From 3 Months in Hemoglobin A1c at 6 Months	Average change in hemoglobin A1c from 3 months to 6 months for the intervention group.	Months 3 to 6
Proportion of Patients Who Achieve Glycemic Targets	Achieving glycemic target defined as reduction in hemoglobin A1c <7% by 3 months after baseline	3 months
Proportion of Patients Who Maintain Glycemic Targets	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.	6 months
Change From Baseline in Diabetes Distress at 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.	Baseline to 3 months
Change From Baseline in Diabetes Distress at 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.	Baseline to 6 months
Change From 3 Months in Diabetes Distress at 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.	Month 3 to month 6
Participant Acceptability of Insulin Dosing Support System for Insulin Titration	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.	3 months
Participant Satisfaction With Insulin Treatment	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.	6 months
Number of Hypoglycemic Events	Total number of hypoglycemic events where blood glucose <70mg/dl.	As reported across study period, up to 6 months
Number of Participants Who Experienced Severe Hypoglycemic Events.	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.	As reported across study period, up to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Escalation of Care	Frequency of endocrinology and other medical visits beyond protocol will be used to assess escalation of care	As reported across study period, up to 6 months
Participant Use of My Dose Coach	Patient use of My Dose Coach app was track through the app's data analytics software platform. High app use was defined as logging in app >3days per week.	As reported across study period, up to 6 months
Number of Technical Complaints	Number of technical complaints made by participants about My Dose Coach app	As reported across study period, up to 6 months
Type of Technical Complaints	Type of technical complaints made by participants about My Dose Coach app	As reported across study period, up to 6 months
Type of Escalation of Care	Type of endocrinology and other medical visits beyond protocol were used to assess escalation of care	As reported across study period, up to 6 months

Collaborators and Investigators

• Sponsor: Linda Siminerio
• Collaborators: Sanofi
• Investigators: Principal Investigator: Linda Siminerio, RN, PhD, CDE, Professor

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): February 16, 2023

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 22, 2020

Study Record Updates

• Last Update Posted (Estimated): February 14, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Mobile application; Digital titration
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: STUDY20040308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A consent form used in enrolling participants will be posted.
• IPD Sharing Time Frame: After the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.
• IPD Sharing Access Criteria: ICF will be added to Clinicaltrials.gov record.
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No