My Diabetes Study - CGM Initiation Approach & Time In Range

Completed · Not applicable

Conditions studied: Type 2 Diabetes

In brief

This study includes two phases. The purpose of Phase 1 of this study is to understand if there is a difference between two ways of introducing a continuous glucose monitor (CGM) to people with type 2 diabetes (T2D). The study will evaluate the effect of using a nutrition-focused approach (NFA) versus a self-directed approach (SDA) during CGM initiation on time in range (TIR) glucose. TIR is the percent of time that someone's glucose is between 70 and 180 mg/dL. It is possible that the approach used to introduce the CGM could impact TIR and other outcomes. The purpose of Phase 2 of the study is to evaluate the impact of discontinuing CGM for 4 months after the completion of the Phase 1 study intervention on CGM-derived metrics, dietary intake assessment, and patient reported outcomes.

Key facts

Study ID

NCT05928572

Run by

Holly Willis

People needed

159

Starts

2023-07-25

Expected to finish

2024-12-31

Last updated by the study team

2026-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults >18 years of age
• T2D diagnosis
• HbA1c 7.0%-10.0% based on point-of-care test at screening
• Taking no diabetes medication or taking stable-dose diabetes medication(s) for at least 30 days; willing to maintain stable diabetes medication regimen for the duration of the study
• Has a personal cellular-plan or wifi-connected smartphone that is compatible with required CGM apps and which will be consistently available for duration of the study
• Has not used a personal CGM system within 90 days
• Willing and able to wear CGM and use the associated CGM mobile apps throughout the duration of the study
• Willing and able to make diet/lifestyle modifications in response to CGM data
• Able to read and understand English
• Able to attend study visits and complete the requirements of study

You may not qualify if…

• Currently taking or planning to take any form of insulin, sulfonylureas, meglitinides, or other anti-hyperglycemic diabetes medication that carry a known hypoglycemia risk
• Has used a personal CGM in the 90 days prior to consent
• Known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin
• Skin conditions that are not compatible with CGM wear
• Intended use of > 4g acetaminophen/day or hydroxyurea during the study
• Planning to become pregnant; pregnant; or lactating
• Current participation in another interventional clinical trial
• Unsuitable for participation due to any other cause, including but not limited to significant comorbidities, as determined by Investigator

Where it is running

• HealthPartners Institute dba International Diabetes Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.