My Diabetes Study - CGM Initiation Approach & Time In Range
Type 2 Diabetes
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring continuous glucose monitor, CGM, nutrition, diet, lifestyle, behavior change
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
Sites / Locations
- HealthPartners Institute dba International Diabetes CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Nutrition-Focused Approach (NFA)
Self-Directed Approach (SDA)
NFA arm participants will receive introduction to CGM from a diabetes care provider with emphasis placed on using the CGM data to adjust food choices. The NFA will encourage food choices that align with evidence-based nutrition recommendations for People with Diabetes (PWD), and that achieve internationally recognized glucose targets (e.g. glucose 70-180 mg/dL, and Time In Range > 70%).
The SDA arm participants will receive introduction to the CGM from a diabetes care provider using the CGM manufacturer-provided manuals and resources. The SDA will encourage participants to use the CGM device and apps in the way that feels most useful to them. The SDA is intended to reflect current CGM initiation practices, which focus on technical use of the CGM and a general review of CGM data.