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

NCT04667182 | Withdrawn

• 2 other identifiers: 17420F3Z-MC-IORN
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Keywords

T1D; T2D

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Area Under the Curve (AUC) of CGM

  Change from Baseline in AUC of CGM

  Baseline, Week 17

Secondary Outcomes (5)

• Qualitative data from study investigators and participants

  Baseline through Week 17

• Percent Time-in-Range (TIR)

  Baseline through Week 17

• Postprandial TIR

  Baseline through Week 17

• Time Above Range (TAR)

  Baseline through Week 17

• Time Below Range (TBR) <70 mg/dL

  Baseline through Week 17

Study Arms (1)

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:; Device: Fitness Tracker

Interventions

Meal-Tagging App and Web-based Portal: OTHER

Meal tagging app to capture frequently eaten meals and test meals for 18 weeks.

Combined Diabetes Management Data

Fitness Tracker DEVICE

Fitness tracker will be worn around the clock for 18 weeks.

Combined Diabetes Management Data

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with T1D and T2D

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 14, 2020
• Study Start: January 25, 2021
• Primary Completion: December 6, 2021
• Study Completion: December 6, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)