My Dose Coach Mobile App to Support Insulin Titration and Maintenance

NCT04678661 | Terminated Results FDA Device

• 1 other identifier: STUDY20040308
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Type 2 - Insulin-Treated

Keywords

Mobile application; Digital titration

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glycemic Control at 3 Months

  Average change in hemoglobin A1c from baseline to 3 months

  Baseline to 3 months

Secondary Outcomes (14)

• Change From Baseline in Fasting Blood Glucose at 3 Months

  Baseline to 3 months

• Change From Baseline in Fasting Blood Glucose at 6 Months

  Baseline to 6 months

• Change From 3 Months in Fasting Blood Glucose at 6 Months

  Months 3 to 6

• 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

Other Outcomes (5)

• Participant Use of My Dose Coach

  As reported across study period, up to 6 months

• Number of Technical Complaints

  As reported across study period, up to 6 months

• Frequency of Escalation of Care

  As reported across study period, up to 6 months

Study Arms (2)

My Dose Coach (Insulin Dosing Support App)

EXPERIMENTAL

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; Behavioral: Standard Insulin Therapy Education

Usual Care Group

ACTIVE COMPARATOR

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

Interventions

Smartphone application and web portal DEVICE

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.

Also known as: My Dose Coach

My Dose Coach (Insulin Dosing Support App)

Standard Insulin Therapy Education BEHAVIORAL

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.

My Dose Coach (Insulin Dosing Support App); Usual Care Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Pregnant or breastfeeding
• Patients unwilling to use MDC app

Sponsors & Collaborators

• Linda Siminerio: lead
• Sanofi: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

• 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.

  PMID: 15735199 RESULT

• 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.

  PMID: 22228744 RESULT

• 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.

  PMID: 24673614 RESULT

Limitations and Caveats

The trial was implemented during the COVID-19 pandemic and there were restrictions and challenges with meeting enrollment goals. Early on in the study, a technical issue with the intervention app was discovered and required that the study be paused while the issue was addressed, further impacting enrollment goals. Also, the study design included a historic control group to make best use of available resources, which limited comparisons among study groups.

Results Point of Contact

• Title: Dr. Linda Siminerio
• Organization: University of Pittsburgh

similx@upmc.edu

412-559-0359

Study Officials

• Linda Siminerio, RN, PhD, CDE

  Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 22, 2020
• Study Start: February 15, 2021
• Primary Completion: December 30, 2022
• Study Completion: February 16, 2023
• Last Updated: February 14, 2024
• Results First Posted: February 14, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• 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.
• Access Criteria: ICF will be added to Clinicaltrials.gov record.

Locations

US (1)