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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-25

Study Completion Date

2021-12-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 1 Diabetes Type 2 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Meal-Tagging App and Web-based Portal:

Intervention Type OTHER

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

Fitness Tracker

Intervention Type DEVICE

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

Interventions

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Meal-Tagging App and Web-based Portal:

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

Intervention Type OTHER

Fitness Tracker

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No