N/A
Completed N=163
IGNITE (Impact of Glucose moNitoring and nutrItion on Time in rangE)
Source: ClinicalTrials.gov NCT05516797 ↗Enrolled (actual)
163
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Difference in Change in 14-day CGM-derived TIR From (3 Months Minus Baseline) — 28; 22 percentage of time with glucose 70-180 m
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Change in 14-day CGM-derived TIR From (3 Months Minus Baseline) |
28; 22 | — |
| SECONDARY 90-day Mean Blood Ketone Levels |
0.54; 0.48 | — |
| SECONDARY Participants Reaching CGM-derived Consensus Targets |
81; 66 | — |
| SECONDARY Difference in Change in HbA1c |
-1.6; -1.5 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05516797). 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.