IGNITE (Impact of Glucose moNitoring and nutrItion on Time in rangE)

HealthPartners Institute

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Device: Continuous Glucose Monitoring (CGM)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05516797

A22-076

Details and patient eligibility

About

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.

Full description

The purpose of this three-month, randomized, controlled trial is to compare the difference in change in 14-day CGM-derived TIR (% time with glucose 70-180 mg/dL) from Baseline to 3-months Post-Dietary Change in participants with T2D who are assigned to use either BGM or CGM. The difference in mean blood ketone levels and additional glycemic endpoints will also be compared, and several exploratory endpoints, including medication changes, dietary intake, and body weight will be described.

The study also includes a three-month Follow-Up period (months three to six), where participants will remain using their randomly assigned glucose monitoring modality (e.g., BGM or CGM); this period will help assess durability of the results found during the intervention.

This study will provide insights into how continuous feedback from CGM affects glycemic outcomes, such as TIR and HbA1c, compared to the standard method of BGM. It is important to understand if the methods of glucose monitoring differ, because greater TIR and lower HbA1c are associated with reduced risk of diabetes complications.

While many studies have compared the differences in glycemic outcomes between BGM and CGM, this study compares differences between the two glucose monitoring methods as part of a randomized, controlled intervention in people with T2D where dietary patterns will be adjusted. It is possible that this study will help demonstrate whether the continuous feedback provided by CGM influences adherence to dietary guidance.

Enrollment: 178 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

178 participants in 2 patient groups

Continuous Glucose Monitoring (CGM)

Experimental group

Description:

Participants in this arm will use the FreeStyle Libre 2 CGM sensor.

Treatment:

Device: Continuous Glucose Monitoring (CGM)

Blood Glucose Monitoring (BGM)

No Intervention group

Description:

Participants in this arm will use the Precision Xtra fingerstick blood glucose meter throughout the study.