Type 2 Diabetes Clinical Trial
— IGNITEOfficial title:
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)
Verified date | September 2023 |
Source | HealthPartners Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 | Completed |
Enrollment | 178 |
Est. completion date | March 1, 2024 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age > 18 years 2. U.S. residence with plans to remain in the U.S. for study duration (for shipping purposes) 3. Diagnosis of T2D 4. HbA1c between 7.5-11.5% documented within 60 days prior to consent 5. Stable diabetes medication regimen and lifestyle patterns (eating and activity) within approximately 90 days prior to consent 6. 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.) 7. English language comprehension 8. Confirmed download of FreeStyle Libre 2 app on personal smartphone with access to WiFi 9. Willing and able to record study data using smartphone, tablet, and/or computer 10. Willing to wear and use study-provided CGM devices for up to 7 months 11. Willing to perform fingersticks to test blood glucose 12. Willing to perform fingersticks to test blood ketones twice daily 13. Eligible to initiate and intention to participate in the dietary changes required as part of the Virta Treatment for at least 7 months Exclusion Criteria: 1. Type 1 diabetes 2. 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 3. Currently following a self-reported, very low-carbohydrate eating pattern 4. Currently using a personal CGM or plans to use a personal CGM during the study period 5. Advanced-stage renal, cardiac, hepatic, or other chronic disease 6. History of ketoacidosis 7. Pregnant, lactating, or planned pregnancy 8. Allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin 9. Participation in another interventional trial at the time of enrollment or during the study period 10. Participant is unsuitable for participation due to any cause as determined by Investigators |
Country | Name | City | State |
---|---|---|---|
United States | Health Partners Institute dba International Diabetes Center | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
HealthPartners Institute | Abbott Diabetes Care, Virta Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Difference in change in the CGM-derived metric, Time above range > 250 mg/dL , from Baseline to 3-month Post-Dietary Change period | Time above range > 250 mg/dL | Three (3) months | |
Other | Difference in change in the CGM-derived metric, Time below range <70 mg/dL , from Baseline to 3-month Post-Dietary Change period | Time below range <70 mg/dL | Three (3) months | |
Other | Difference in change in the CGM-derived metric, Time below range <54 mg/dL , from Baseline to 3-month Post-Dietary Change period | Time below range <54 mg/dL | Three (3) months | |
Other | Difference in change in the CGM-derived metric, Mean sensor glucose, from Baseline to 3-month Post-Dietary Change period | Mean sensor glucose | Three (3) months | |
Other | Difference in change in the CGM-derived metric, % Coefficient of variation, from Baseline to 3-month Post-Dietary Change period | % Coefficient of variation | Three (3) months | |
Other | Difference in change in the CGM-derived metric, Mean amplitude of glucose excursion, from Baseline to 3-month Post-Dietary Change period | Mean amplitude of glucose excursion | Three (3) months | |
Primary | Difference in change in 14-day CGM-derived TIR | Difference in change in 14-day CGM-derived TIR (% time with glucose 70-180 mg/dL) from Baseline to 3-month Post-Dietary Change period between participants with T2D who are randomized to use either BGM or CGM as part of Virta Treatment. | Three (3) months | |
Secondary | Difference in 90-day mean blood ketone levels | Difference in 90-day mean blood ketone levels between BGM and CGM arms | Three (3) months | |
Secondary | Difference in change in the CGM-derived metric, Time above range > 180 mg/dL, from Baseline to 3-month Post-Dietary Change period | Time above range > 180 mg/dL | Three (3) months | |
Secondary | Difference in percent of participants reaching CGM-derived consensus targets | Difference in percent of participants reaching CGM-derived consensus targets at the end of the 3-month Post-Dietary Change period between BGM and CGM arms | Three (3) months | |
Secondary | Difference in Change in HbA1c | Difference in Change in HbA1c from Baseline to the end of the 3-month Post-Dietary Change period between BGM and CGM arms | Three (3) months |
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