IGNITE (Impact of Glucose moNitoring and nutrItion on Time in rangE)
Completed · Not applicable
Conditions studied: Type 2 Diabetes
In brief
The purpose of this study is to learn whether there is a difference in the amount of time glucose (blood sugar) stays within a target range (glucose 70 - 180 mg/dl) when using either continuous glucose monitoring (CGM) or fingerstick blood glucose monitoring (BGM) in people with Type 2 diabetes who participate in the Virta Treatment program.
Key facts
- Study ID
- NCT05516797
- Run by
- HealthPartners Institute
- People needed
- 178
- Starts
- 2022-09-22
- Expected to finish
- 2024-03-01
- Last updated by the study team
- 2025-03-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age > 18 years
- U.S. residence with plans to remain in the U.S. for study duration (for shipping purposes)
- Diagnosis of T2D
- HbA1c between 7.5-11.5% documented within 60 days prior to consent
- Stable diabetes medication regimen and lifestyle patterns (eating and activity) within approximately 90 days prior to consent
- Using at least one glucose-lowering medication (oral or injectable) for diabetes management at the time of consent; if using insulin, this may include up to a total of three or fewer insulin injections per day (e.g., once or twice daily basal insulin, once or twice daily basal insulin plus one prandial insulin dose, once or twice daily pre-mix insulin, or another combination etc.)
- English language comprehension
- Confirmed download of FreeStyle Libre 2 app on personal smartphone with access to WiFi
- Willing and able to record study data using smartphone, tablet, and/or computer
- Willing to wear and use study-provided CGM devices for up to 7 months
- Willing to perform fingersticks to test blood glucose
- Willing to perform fingersticks to test blood ketones twice daily
- Eligible to initiate and intention to participate in the dietary changes required as part of the Virta Treatment for at least 7 months
You may not qualify if…
- Type 1 diabetes
- Currently using an insulin pump or multiple daily injection insulin therapy with >3 insulin injections per day or using bolus injections to cover every meal
- Currently following a self-reported, very low-carbohydrate eating pattern
- Currently using a personal CGM or plans to use a personal CGM during the study period
- Advanced-stage renal, cardiac, hepatic, or other chronic disease
- History of ketoacidosis
- Pregnant, lactating, or planned pregnancy
- Allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin
- Participation in another interventional trial at the time of enrollment or during the study period
- Participant is unsuitable for participation due to any cause as determined by Investigators
Where it is running
- Health Partners 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.