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

NCT05516797 | Completed Results FDA Device

• 1 other identifier: A22-076
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Continuous Glucose Monitoring (CGM); Blood Glucose Monitoring (BGM); Nutrition Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 90-day Mean Blood Ketone Levels

  Three (3) months / 90 days

• Participants Reaching CGM-derived Consensus Targets

  Three (3) months

• Difference in Change in HbA1c

  Three (3) months

Other Outcomes (5)

• Difference in Change in CGM-derived Metric %Time Above Range >180 mg/dL During 3-month Post-Dietary Change Period (3 Month Minus Baseline)

  Three (3) months

• Difference in Change in the CGM-derived Metric, %Time Below Range <70 mg/dL (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)

  Three (3) months (baseline to three months)

Study Arms (2)

Continuous Glucose Monitoring (CGM)

EXPERIMENTAL

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

Device: Continuous Glucose Monitoring (CGM)

Blood Glucose Monitoring (BGM)

NO INTERVENTION

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

Interventions

Continuous Glucose Monitoring (CGM) DEVICE

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

Continuous Glucose Monitoring (CGM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HealthPartners Institute: lead
• Virta Health: collaborator
• Abbott Diabetes Care: collaborator

Study Sites (1)

Health Partners Institute dba International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Limitations and Caveats

CGM was compared with BGM in people with T2D; however, many people with T2D do not regularly use glucose monitoring, it would have been ideal to compare both groups to a third arm that was not using any glucose monitoring.

Results Point of Contact

• Title: Holly Willis
• Organization: HealthPartners Institute

holly.willis@parknicollet.com

952-993-3219

Study Officials

• Holly Willis, PhD

  HealthPartners Institute dba International Diabetes Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 26, 2022
• Study Start: September 22, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 26, 2025
• Results First Posted: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)