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

Primary Purpose

Type 2 Diabetes

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Glucose Monitoring (CGM)
Sponsored by
HealthPartners Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Continuous Glucose Monitoring (CGM), Blood Glucose Monitoring (BGM), Nutrition Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Health Partners Institute dba International Diabetes Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Continuous Glucose Monitoring (CGM)

Blood Glucose Monitoring (BGM)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Difference in change in 14-day CGM-derived TIR
Difference in 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 as part of Virta Treatment.

Secondary Outcome Measures

Difference in 90-day mean blood ketone levels
Difference in 90-day mean blood ketone levels between BGM and CGM arms
Difference in change in the CGM-derived metric, Time above range > 180 mg/dL, from Baseline to 3-month Post-Dietary Change period
Time above range > 180 mg/dL
Difference in percent of participants reaching CGM-derived consensus targets
Difference in percent of participants reaching CGM-derived consensus targets at the end of the 3-month Post-Dietary Change period between BGM and CGM arms
Difference in Change in HbA1c
Difference in Change in HbA1c from Baseline to the end of the 3-month Post-Dietary Change period between BGM and CGM arms

Full Information

First Posted
August 9, 2022
Last Updated
September 13, 2023
Sponsor
HealthPartners Institute
Collaborators
Virta Health, Abbott Diabetes Care
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1. Study Identification

Unique Protocol Identification Number
NCT05516797
Brief Title
IGNITE (Impact of Glucose moNitoring and nutrItion on Time in rangE)
Acronym
IGNITE
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 22, 2022 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute
Collaborators
Virta Health, Abbott Diabetes Care

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Continuous Glucose Monitoring (CGM), Blood Glucose Monitoring (BGM), Nutrition Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuous Glucose Monitoring (CGM)
Arm Type
Experimental
Arm Description
Participants in this arm will use the FreeStyle Libre 2 CGM sensor.
Arm Title
Blood Glucose Monitoring (BGM)
Arm Type
No Intervention
Arm Description
Participants in this arm will use the Precision Xtra fingerstick blood glucose meter throughout the study.
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitoring (CGM)
Intervention Description
Use of CGM (FreeStyle Libre 2) compared to BGM for glucose monitoring
Primary Outcome Measure Information:
Title
Difference in change in 14-day CGM-derived TIR
Description
Difference in 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 as part of Virta Treatment.
Time Frame
Three (3) months
Secondary Outcome Measure Information:
Title
Difference in 90-day mean blood ketone levels
Description
Difference in 90-day mean blood ketone levels between BGM and CGM arms
Time Frame
Three (3) months
Title
Difference in change in the CGM-derived metric, Time above range > 180 mg/dL, from Baseline to 3-month Post-Dietary Change period
Description
Time above range > 180 mg/dL
Time Frame
Three (3) months
Title
Difference in percent of participants reaching CGM-derived consensus targets
Description
Difference in percent of participants reaching CGM-derived consensus targets at the end of the 3-month Post-Dietary Change period between BGM and CGM arms
Time Frame
Three (3) months
Title
Difference in Change in HbA1c
Description
Difference in Change in HbA1c from Baseline to the end of the 3-month Post-Dietary Change period between BGM and CGM arms
Time Frame
Three (3) months
Other Pre-specified Outcome Measures:
Title
Difference in change in the CGM-derived metric, Time above range > 250 mg/dL , from Baseline to 3-month Post-Dietary Change period
Description
Time above range > 250 mg/dL
Time Frame
Three (3) months
Title
Difference in change in the CGM-derived metric, Time below range <70 mg/dL , from Baseline to 3-month Post-Dietary Change period
Description
Time below range <70 mg/dL
Time Frame
Three (3) months
Title
Difference in change in the CGM-derived metric, Time below range <54 mg/dL , from Baseline to 3-month Post-Dietary Change period
Description
Time below range <54 mg/dL
Time Frame
Three (3) months
Title
Difference in change in the CGM-derived metric, Mean sensor glucose, from Baseline to 3-month Post-Dietary Change period
Description
Mean sensor glucose
Time Frame
Three (3) months
Title
Difference in change in the CGM-derived metric, % Coefficient of variation, from Baseline to 3-month Post-Dietary Change period
Description
% Coefficient of variation
Time Frame
Three (3) months
Title
Difference in change in the CGM-derived metric, Mean amplitude of glucose excursion, from Baseline to 3-month Post-Dietary Change period
Description
Mean amplitude of glucose excursion
Time Frame
Three (3) months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly Willis, PhD
Organizational Affiliation
HealthPartners Institute dba International Diabetes Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Partners Institute dba International Diabetes Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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