Type 2 DiabetesIGNITENCT05516797
IGNITE (Impact of Glucose moNitoring and nutrItion on Time in rangE)
A study testing Continuous Glucose Monitoring (CGM) in people with Type 2 Diabetes, run by HealthPartners Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Continuous Glucose Monitoring (CGM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2022to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Health Partners Institute dba International Diabetes Center
Minneapolis, Minnesota, 55416
About this study
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)
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.
Read the 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
- Being tested
- Continuous Glucose Monitoring (CGM)
- Keywords
- Continuous Glucose Monitoring (CGM), Blood Glucose Monitoring (BGM), Nutrition Therapy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitoring (CGM)Device
Use of CGM (FreeStyle Libre 2) compared to BGM for glucose monitoring
| Study group | Role | What they receive |
|---|---|---|
| Continuous Glucose Monitoring (CGM) | Experimental | Participants in this arm will use the FreeStyle Libre 2 CGM sensor. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Three (3) months
Secondary outcomes (3)
90-day Mean Blood Ketone Levels
Mean of blood ketone levels from day 0 to day 90 (three months).
Measured: 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
Measured: 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
Measured: Three (3) months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start22 Sep 2022
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Virta Health, Abbott Diabetes Care
- Responsible party
- Sponsor
- Investigators
- Holly Willis, PhD, Principal investigator, HealthPartners Institute dba International Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516797
- Sponsor's protocol ID
- A22-076
- Acronym
- IGNITE
- Status last verified
- Mar 2025
- First submitted
- 9 Aug 2022
- Last updated
- 26 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05516797
- Acronym / sponsor ID
- IGNITE / A22-076
- Conditions
- Type 2 Diabetes
- Keywords
- Continuous Glucose Monitoring (CGM), Blood Glucose Monitoring (BGM), Nutrition Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- Virta Health, Abbott Diabetes Care
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 26 Aug 2022 (actual)
- Results
- Posted 26 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Glucose Monitoring (CGM) | Experimental | Device: Continuous Glucose Monitoring (CGM)Participants in this arm will use the FreeStyle Libre 2 CGM sensor. |
| Blood Glucose Monitoring (BGM) | No intervention | –Participants in this arm will use the Precision Xtra fingerstick blood glucose meter throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Glucose Monitoring (CGM)Use of CGM (FreeStyle Libre 2) compared to BGM for glucose monitoring | Device | Continuous Glucose Monitoring (CGM) |
Primary outcome
Difference in Change in 14-day CGM-derived TIR From (3 Months Minus Baseline)
Time frame: Three (3) months
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)
3 secondary outcomes
90-day Mean Blood Ketone Levels
Time frame: Three (3) months / 90 days
Participants Reaching CGM-derived Consensus Targets
Time frame: Three (3) months
Difference in Change in HbA1c
Time frame: Three (3) months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holly Willis, PhD principal investigator
HealthPartners Institute dba International Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitoring (CGM) in people with Type 2 Diabetes, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Change in 14-day CGM-derived TIR From (3 Months Minus Baseline) (time frame: Three (3) months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.