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

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)

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Device: Continuous Glucose Monitoring (CGM)

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.

• Study Type: Interventional
• Enrollment (Actual): 178
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • Health Partners Institute dba International Diabetes Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous Glucose Monitoring (CGM); Participants in this arm will use the FreeStyle Libre 2 CGM sensor.	Device: Continuous Glucose Monitoring (CGM); Use of CGM (FreeStyle Libre 2) compared to BGM for glucose monitoring
No Intervention: Blood Glucose Monitoring (BGM); Participants in this arm will use the Precision Xtra fingerstick blood glucose meter throughout the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Change in 14-day CGM-derived TIR From (3 Months Minus Baseline)	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 (3 months minus baseline)	Three (3) months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
90-day Mean Blood Ketone Levels	Mean of blood ketone levels from day 0 to day 90 (three months).	Three (3) months / 90 days
Participants Reaching CGM-derived Consensus Targets	Percent of participants reaching CGM-derived consensus targets (targets defined as meeting both >70% TIR70-180 mg/dL and <4% TBR <70mg/dL) at the end of the 3-month Post-Dietary in both the BGM and CGM arms	Three (3) months
Difference in Change in HbA1c	Change in HbA1c from Baseline to the end of the 3-month Post-Dietary Change period between BGM and CGM arms	Three (3) months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Change in CGM-derived Metric %Time Above Range >180 mg/dL During 3-month Post-Dietary Change Period (3 Month Minus Baseline)	Change in the % time above range >180 mg/dL, during the Baseline to 3-month Post-Dietary Change period for both arms (3 months minus baseline)	Three (3) months
Difference in Change in the CGM-derived Metric, %Time Below Range <70 mg/dL (3 Months Minus Baseline)	Change in %Time below range <70 mg/dL during the Baseline to 3-month Post-Dietary Change period (3 months minus baseline)	3 months (baseline to three months)
Difference in Change in the CGM-derived Metric %Time Below Range <54 mg/dL, From Baseline to 3-month Post-Dietary Change Period (3 Months Minus Baseline)	Change in % Time with glucose below range <54 mg/dL from Baseline to 3-month Post-Dietary Change (3 months minus baseline)	Three (3) months (baseline to three months)
Difference in Change in the CGM-derived Metric, Mean Sensor Glucose, From Baseline to 3-month Post-Dietary Change Period (3 Months Minus Baseline)	Change in the CGM-derived metric, Mean sensor glucose, from baseline to three months	Three (3) months (baseline to three months)
Difference in Change in the CGM-derived Metric, % Coefficient of Variation, From Baseline to 3-month Post-Dietary Change Period (3 Months Minus Baseline)	Change in % Coefficient of variation from Baseline to 3-month Post-Dietary Change (3 months minus baseline)	Three (3) months (baseline to three months)

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Collaborators: Abbott Diabetes Care; Virta Health
• Investigators: Principal Investigator: Holly Willis, PhD, HealthPartners Institute dba International Diabetes Center

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2022
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitoring (CGM); Nutrition Therapy; Blood Glucose Monitoring (BGM)
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: A22-076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes