N/A
Completed N=132
My Diabetes Study - CGM Initiation Approach & Time In Range
Source: ClinicalTrials.gov NCT05928572 ↗Enrolled (actual)
132
Serious AEs
1.3%
Results posted
Mar 2026
Primary outcomePrimary: Phase 1 Change in CGM-derived Time in Range (TIR) — 25; 16 % of time in 24 hours
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1 Change in CGM-derived Time in Range (TIR) |
25; 16 | — |
| SECONDARY Total Healthy Eating Index (HEI) Score |
65; 63 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05928572). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.