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

Withdrawn

• Conditions: Type 1 Diabetes; Type 2 Diabetes
• Interventions: Device: Fitness Tracker

• Registration Number: NCT04667182
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-11
• Study First Posted: 2020-12-14
• Study Start: 2021-01-25
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-10
• Last Update Posted: 2021-09-17
• Primary Completion: 2021-12-06
• Study Completion: 2021-12-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Combined Diabetes Management Data	Fitness Tracker	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Area Under the Curve (AUC) of CGM	Baseline, Week 17	Change from Baseline in AUC of CGM

Secondary Outcome Measures

Name	Time	Method
Percent Time-in-Range (TIR)	Baseline through Week 17	Percent Time-in-Range defined as glucose \>70 and ≤180 milligrams per deciliter \[mg/dL\])
Qualitative data from study investigators and participants	Baseline through Week 17	Qualitative data describing experience from study investigators and participants
Time Above Range (TAR)	Baseline through Week 17	TAR is defined as glucose \> 180 mg/dL
Postprandial TIR	Baseline through Week 17	Postprandial TIR is defined as TIR glucose: glucose \>=70 and ≤180 mg/dL
Time Below Range (TBR) <70 mg/dL	Baseline through Week 17	TBR is defined as glucose \< 70 mg/dL

Trial Locations

Locations (2)

University of North Carolina, Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States