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

Meal-centric Insulin Dosing for Optimized Post-Prandial Glucose Control in People Using Multiple Daily Injections

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.

Study Overview

• Status: Withdrawn
• Conditions: Type 1 Diabetes; Type 2 Diabetes
• Intervention / Treatment: Other: Meal-Tagging App and Web-based Portal:; Device: Fitness Tracker

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina, Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with T1D and T2D

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Combined Diabetes Management Data; 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.	Other: Meal-Tagging App and Web-based Portal: Meal tagging app to capture frequently eaten meals and test meals for 18 weeks.; Device: Fitness Tracker; Fitness tracker will be worn around the clock for 18 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Area Under the Curve (AUC) of CGM	Change from Baseline in AUC of CGM	Baseline, Week 17

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Anticipated): January 25, 2021
• Primary Completion (Anticipated): December 6, 2021
• Study Completion (Anticipated): December 6, 2021

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Actual): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: T1D; T2D
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 17420; F3Z-MC-IORN (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No