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

NCT ID: NCT05516797

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-22
• Study Completion Date: 2024-03-01

Brief 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.

Detailed 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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Continuous Glucose Monitoring (CGM)

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

Group Type: EXPERIMENTAL

Continuous Glucose Monitoring (CGM)

Intervention Type: DEVICE

Use of CGM (FreeStyle Libre 2) compared to BGM for glucose monitoring

Blood Glucose Monitoring (BGM)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Continuous Glucose Monitoring (CGM)

Use of CGM (FreeStyle Libre 2) compared to BGM for glucose monitoring

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virta Health

INDUSTRY

Sponsor Role: collaborator

Abbott Diabetes Care

INDUSTRY

Sponsor Role: collaborator

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Holly Willis, PhD

Role: PRINCIPAL_INVESTIGATOR

HealthPartners Institute dba International Diabetes Center

Locations

Health Partners Institute dba International Diabetes Center

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

A22-076

Identifier Type: -

Identifier Source: org_study_id