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| Name | Class |
|---|---|
| Virta Health | INDUSTRY |
| Abbott Diabetes Care | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Glucose Monitoring (CGM) | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitoring (CGM) | Device | Use of CGM (FreeStyle Libre 2) compared to BGM for glucose monitoring |
|
| 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 |
| 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 |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holly Willis, PhD | HealthPartners Institute dba International Diabetes Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Partners Institute dba International Diabetes Center | Minneapolis | Minnesota | 55416 | United States |
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All participants were required to complete a baseline assessment period prior to beginning the intervention. This included wearing a blinded CGM for up to 14-days along with assessment of HbA1c and completion of several surveys. More participants were enrolled than were randomized. Some participants who enrolled did not complete the required baseline assessment requirements for randomization or they voluntarily withdrew before randomization. This is why N=178 enrolled and N=163 were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Glucose Monitoring (CGM) Arm | Participants in this arm took part in a medically supervised ketogenic diet program. They wore and used a Freestyle Libre 2 continuous glucose monitoring system on thier personal smartphone during the entire intervention period. |
| FG001 | Blood Glucose Monitoring (BGM) Arm | Participants in this arm took part in a medically supervised ketogenic diet program. The BGM arm participants used a Precision Xtra Blood Glucose and Ketone Monitoring System (Abbott Diabetes Care) daily; fingerstick glucose testing was prescribed on an individual basis. Participants in this arm also wore a blinded Freestyle Libre Pro continuous glucose monitoring system during specified intervals throughout the intervention period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Information about the analyzed population matches the number of participants assigned to each arm. Analysis information is presented for N=81 in CGM and N=82 in BGM.
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| ID | Title | Description |
|---|---|---|
| BG000 | Continuous Glucose Monitoring (CGM) Arm | Participants in this arm took part in a medically supervised ketogenic diet program. They wore and used a Freestyle Libre 2 continuous glucose monitoring system on thier personal smartphone during the entire intervention period. |
| BG001 | Blood Glucose Monitoring (BGM) Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Participants with adequate blinded CGM data at baseline and at month 3 were included. | Posted | Mean | 95% Confidence Interval | percentage of time with glucose 70-180 m | Three (3) months |
|
Adverse and Serious adverse events were collected from the time of consent through the end of study completion, this is approximately seven months for each participant when considering the baseline assessment period and the intervention period.
AEs were defined as (1) severe CGM sensor-related reactions/infections requiring in-person medical care, (2) severe hypoglycemia that required assistance of another person due to altered consciousness or (3) severe hyperglycemia if the event involved diabetic ketoacidosis hyperosmolar or hyperglycemic state, as defined by Kitabchi et al. SAEs were defined as anything serious, unexpected, and probably, possibly, or definitely related to the glucose monitoring device or research procedures.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Continuous Glucose Monitoring (CGM) Arm | Participants in this arm took part in a medically supervised ketogenic diet program. They wore and used a Freestyle Libre 2 continuous glucose monitoring system on thier personal smartphone during the entire intervention period. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Holly Willis | HealthPartners Institute | 952-993-3219 | holly.willis@parknicollet.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 3, 2023 | Mar 5, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| 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 |
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) |
Participants in this arm took part in a medically supervised ketogenic diet program. The BGM arm participants used a Precision Xtra Blood Glucose and Ketone Monitoring System (Abbott Diabetes Care) daily; fingerstick glucose testing was prescribed on an individual basis. Participants in this arm also wore a blinded Freestyle Libre Pro continuous glucose monitoring system during specified intervals throughout the intervention period. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Hb1ac | Mean | Standard Deviation | percentage of glycated hemoglobin |
|
| Blood Glucose Monitoring (BGM) Arm |
Participants in this arm took part in a medically supervised ketogenic diet program. The BGM arm participants used a Precision Xtra Blood Glucose and Ketone Monitoring System (Abbott Diabetes Care) daily; fingerstick glucose testing was prescribed on an individual basis. Participants in this arm also wore a blinded Freestyle Libre Pro continuous glucose monitoring system during specified intervals throughout the intervention period. |
|
|
| Secondary | 90-day Mean Blood Ketone Levels | Mean of blood ketone levels from day 0 to day 90 (three months). | Results from general and generalized linear mixed models using all available data | Posted | Mean | 95% Confidence Interval | mmol/L | Three (3) months / 90 days |
|
|
|
| Secondary | 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 | Some data missing at random; used all available and qualifying data | Posted | Number | 95% Confidence Interval | percentage of participants | Three (3) months |
|
|
|
| Secondary | 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 | Some data missing at random; all available and qualifying data were used | Posted | Mean | 95% Confidence Interval | percentage of glycated hemoglobin | Three (3) months |
|
|
|
| Other Pre-specified | 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) | Some data were missing at random; analysis used all available qualifying data | Posted | Mean | 95% Confidence Interval | percent time with glucose >180mg/dL | Three (3) months |
|
|
|
| Other Pre-specified | 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) | some data missing at random; all available and qualifying data were used | Posted | Mean | 95% Confidence Interval | percent time with glucose <70mg/dL | 3 months (baseline to three months) |
|
|
|
| Other Pre-specified | 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) | some data missing at random; all available and qualifying data were used | Posted | Mean | 95% Confidence Interval | percent time with glucose <54 mg/dL | Three (3) months (baseline to three months) |
|
|
|
| Other Pre-specified | 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 | some data missing at random; all available and qualifying data were used | Posted | Mean | 95% Confidence Interval | mg/dL | Three (3) months (baseline to three months) |
|
|
|
| Other Pre-specified | 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) | some data missing at random; all available and qualifying data were used | Posted | Mean | 95% Confidence Interval | percent of coefficient of variation | Three (3) months (baseline to three months) |
|
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| 0 |
| 81 |
| 0 |
| 81 |
| 0 |
| 81 |
| EG001 | Blood Glucose Monitoring (BGM) Arm | Participants in this arm took part in a medically supervised ketogenic diet program. The BGM arm participants used a Precision Xtra Blood Glucose and Ketone Monitoring System (Abbott Diabetes Care) daily; fingerstick glucose testing was prescribed on an individual basis. Participants in this arm also wore a blinded Freestyle Libre Pro continuous glucose monitoring system during specified intervals throughout the intervention period. | 0 | 82 | 0 | 82 | 0 | 82 |
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| D004700 | Endocrine System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |