NCT05516797Completed
IGNITE (Impact of Glucose moNitoring and nutrItion on Time in rangE)
Continuous Glucose Monitoring Versus Blood Glucose Monitoring to Optimize Glycemic Outcomes in People With Type 2 Diabetes Following the Virta Treatment Program" (IGNITE: Impact of Glucose moNitoring and nutrItion on Time in rangE Study)
Source: ClinicalTrials.gov · Last updated 26 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 178 (actual)
- First submitted
- 9 Aug 2022
- Start date
- Sept 2022
- Primary completion date
- Mar 2024
- Lead sponsor
- HealthPartners Institute
- Diseases
- Type 2 diabetes
- NCT number
- NCT05516797
What you commit to
- Study type: Interventional
- Participants enrolled: 178
- From Sept 2022 to the primary completion date, Mar 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 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 using a personal CGM or plans to use a personal CGM during the study period
Other illness
- Type 1 diabetes
- Advanced-stage renal, cardiac, hepatic, or other chronic disease
- History of ketoacidosis
- Allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin
Other
- Currently following a self-reported, very low-carbohydrate eating pattern
- Pregnant, lactating, or planned pregnancy
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Health Partners 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.