My Dose Coach Mobile App to Support Insulin Titration and Maintenance

NATerminatedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

February 15, 2021

Primary Completion Date

December 30, 2022

Study Completion Date

February 16, 2023

Conditions
Diabetes Mellitus Type 2 - Insulin-Treated
Interventions
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."

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.

Trial Locations (1)

15213

University of Pittsburgh Medical Center, Pittsburgh

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Linda Siminerio

OTHER