A Study of Glucose Control in Participants With Type 1 and Type 2 Diabetes

Lilly

Status: Withdrawn

Conditions: Type 1 Diabetes; Type 2 Diabetes

Treatments: Device: Fitness Tracker; Other: Meal-Tagging App and Web-based Portal:

Study type: Observational

Funder types: Industry

Identifiers

NCT04667182

17420

F3Z-MC-IORN (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to determine whether combining meal, glucose and insulin data in a web-based system will improve management of type 1 (T1D) and type 2 diabetes (T2D). No study drug will be given. The study will last about 18 weeks.

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals with type 1 or type 2 diabetes for >3 years by clinical diagnosis who use basal insulin, in addition to at least one injection of meal time insulin per day
• Insulin pen use for at least 3 months
• Current use of or willingness to use Dexcom G6 at least 6 out of 7 days per week
• A1c 6.5-9.5%

Exclusion criteria

• Currently using any form of insulin pump, including hybrid closed-loop system (e.g., Medtronic 670G)
• Individuals requiring single insulin boluses of >40 units
• Individuals planning to follow a specific diet plan for weight loss
• Inability to consume regular, consistent meals
• Individuals who have had severe hypoglycemia with seizure or coma within the past 6 months
• Individuals who have been hospitalized for diabetic ketoacidosis (DKA) within the past 6 months

Trial design

0 participants in 1 patient group

Combined Diabetes Management Data

Description:

Participants with type 1 and type 2 diabetes will use a meal tagging application (app) and fitness tracker. They will upload these data to a web portal where they will be matched with data from their insulin pen and continuous glucose monitor (CGM). Combined data will be used as a complement to standard of care for diabetes management.

Treatment:

Other: Meal-Tagging App and Web-based Portal:

Device: Fitness Tracker