NCT05928572Completed
My Diabetes Study - CGM Initiation Approach & Time In Range
Effect of CGM Initiation Approach on Time In Range in People With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 4 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 159 (actual)
- First submitted
- 14 Jun 2023
- Start date
- 25 Jul 2023
- Primary completion date
- 16 Aug 2024
- Lead sponsor
- Holly Willis
- Diseases
- Type 2 diabetes
- NCT number
- NCT05928572
What you commit to
- Study type: Interventional
- Participants enrolled: 159
- From 25 Jul 2023 to the primary completion date, 16 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin
- Skin conditions that are not compatible with CGM wear
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HealthPartners Institute dba International Diabetes Center Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.