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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04667182
• Other study ID #: 17420
• Secondary ID: F3Z-MC-IORN
• Status: Withdrawn
• Start date: January 25, 2021
• Est. completion date: December 6, 2021

Study information

• Verified date: September 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 6, 2021
• Est. primary completion date: December 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Area Under the Curve (AUC) of CGM	Change from Baseline in AUC of CGM	Baseline, Week 17
Secondary	Qualitative data from study investigators and participants	Qualitative data describing experience from study investigators and participants	Baseline through Week 17
Secondary	Percent Time-in-Range (TIR)	Percent Time-in-Range defined as glucose >70 and =180 milligrams per deciliter [mg/dL])	Baseline through Week 17
Secondary	Postprandial TIR	Postprandial TIR is defined as TIR glucose: glucose >=70 and =180 mg/dL	Baseline through Week 17
Secondary	Time Above Range (TAR)	TAR is defined as glucose > 180 mg/dL	Baseline through Week 17
Secondary	Time Below Range (TBR) <70 mg/dL	TBR is defined as glucose < 70 mg/dL	Baseline through Week 17