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Continuous Glucose Monitoring
Continuous Glucose Monitoring for Type 2 Diabetes (IGNITE Trial)
N/A
Waitlist Available
Led By Holly Willis, PhD
Research Sponsored by HealthPartners Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Willing to perform fingersticks to test blood ketones twice daily
Diagnosis of T2D
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three (3) months
Awards & highlights
IGNITE Trial Summary
This trial looks at whether CGM or BGM help people with Type 2 diabetes keep their blood sugar in the right range.
Who is the study for?
This trial is for adults over 18 living in the U.S. with Type 2 Diabetes, using glucose-lowering meds, and willing to use a smartphone for data recording. They should not be on intensive insulin therapy or have other chronic diseases, allergies to certain adhesives or alcohol wipes, nor be pregnant or in another study.Check my eligibility
What is being tested?
The IGNITE study tests if continuous glucose monitoring (CGM) keeps blood sugar within target ranges better than traditional fingerstick testing for people with Type 2 diabetes enrolled in the Virta Treatment program.See study design
What are the potential side effects?
While CGMs are generally safe, potential side effects include skin irritation from adhesive patches and discomfort at sensor insertion sites. Rarely there might be inaccurate readings leading to inappropriate management decisions.
IGNITE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing to check my blood ketones twice a day using a fingerstick.
Select...
I have been diagnosed with type 2 diabetes.
Select...
I am currently taking medication to lower my blood sugar.
Select...
I am older than 18 years.
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I am willing to follow the Virta Treatment diet for at least 7 months.
IGNITE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ three (3) months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three (3) months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference in change in 14-day CGM-derived TIR
Secondary outcome measures
Ketones
Difference in Change in HbA1c
Difference in change in the CGM-derived metric, Time above range > 180 mg/dL, from Baseline to 3-month Post-Dietary Change period
+1 moreOther outcome measures
Difference in change in the CGM-derived metric, % Coefficient of variation, from Baseline to 3-month Post-Dietary Change period
Difference in change in the CGM-derived metric, Mean amplitude of glucose excursion, from Baseline to 3-month Post-Dietary Change period
Difference in change in the CGM-derived metric, Mean sensor glucose, from Baseline to 3-month Post-Dietary Change period
+3 moreIGNITE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Continuous Glucose Monitoring (CGM)Experimental Treatment1 Intervention
Participants in this arm will use the FreeStyle Libre 2 CGM sensor.
Group II: Blood Glucose Monitoring (BGM)Active Control1 Intervention
Participants in this arm will use the Precision Xtra fingerstick blood glucose meter throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous Glucose Monitoring (CGM)
2009
N/A
~330
Find a Location
Who is running the clinical trial?
HealthPartners InstituteLead Sponsor
184 Previous Clinical Trials
3,715,981 Total Patients Enrolled
Virta HealthIndustry Sponsor
4 Previous Clinical Trials
50,827 Total Patients Enrolled
Abbott Diabetes CareIndustry Sponsor
63 Previous Clinical Trials
24,591 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to use a study-provided CGM device for 7 months.I use an insulin pump or take more than 3 insulin injections daily.I am willing to check my blood ketones twice a day using a fingerstick.You are currently using or plan to use a personal continuous glucose monitor (CGM) during the study.Your blood sugar levels (HbA1c) are between 7.5% and 11.5% within the last 60 days before agreeing to participate.I have advanced-stage kidney, heart, liver, or other chronic disease.I am willing to check my blood sugar levels using fingersticks.You have type 1 diabetes.I have had ketoacidosis in the past.I have been diagnosed with type 2 diabetes.I am currently taking medication to lower my blood sugar.You are currently following a very low-carbohydrate diet.I am older than 18 years.I am willing to follow the Virta Treatment diet for at least 7 months.
Research Study Groups:
This trial has the following groups:- Group 1: Continuous Glucose Monitoring (CGM)
- Group 2: Blood Glucose Monitoring (BGM)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current enrollment rate for this trial?
"Affirmative, clinicaltrials.gov displays that this experiment is searching for participants. It was opened on the 22nd of September 2022 and was last amended on the 29th of September 2022. The study aims to enrol 150 patients at one site."
Answered by AI
Are there any current opportunities for enrolment in this experiment?
"Affirmative. Clinicaltrials.gov specifies that this study is actively enrolling participants, with the initial posting of September 22nd 2022 and most recent update on September 29th 2022. The trial aims to sign up a total of 150 patients in one test site."
Answered by AI
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