Type 2 Diabetes
Conditions
Keywords
Continuous Glucose Monitoring (CGM), Blood Glucose Monitoring (BGM), Nutrition Therapy
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.
Interventions
DEVICEContinuous Glucose Monitoring (CGM)
Use of CGM (FreeStyle Libre 2) compared to BGM for glucose monitoring
Sponsors
Virta Health
Abbott Diabetes Care
HealthPartners Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Change in 14-day CGM-derived TIR From (3 Months Minus Baseline) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 90-day Mean Blood Ketone Levels | Three (3) months / 90 days | Mean of blood ketone levels from day 0 to day 90 (three months). |
| Participants Reaching CGM-derived Consensus Targets | Three (3) months | 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 |
| Difference in Change in HbA1c | Three (3) months | Change in HbA1c from Baseline to the end of the 3-month Post-Dietary Change period between BGM and CGM arms |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) |
| Difference in Change in the CGM-derived Metric, % Coefficient of Variation, From Baseline to 3-month Post-Dietary Change Period (3 Months Minus Baseline) | Three (3) months (baseline to three months) | Change in % Coefficient of variation from Baseline to 3-month Post-Dietary Change (3 months minus baseline) |
| Difference in Change in the CGM-derived Metric, %Time Below Range <70 mg/dL (3 Months Minus Baseline) | 3 months (baseline to three months) | Change in %Time below range \<70 mg/dL during the Baseline to 3-month Post-Dietary Change period (3 months minus baseline) |
| 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) | Change in % Time with glucose below range \<54 mg/dL from Baseline to 3-month Post-Dietary Change (3 months minus baseline) |
| Difference in Change in the CGM-derived Metric, Mean Sensor Glucose, From Baseline to 3-month Post-Dietary Change Period (3 Months Minus Baseline) | Three (3) months (baseline to three months) | Change in the CGM-derived metric, Mean sensor glucose, from baseline to three months |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 81 |
| 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. | 82 |
| Total | 163 |
Baseline characteristics
| Characteristic | Continuous Glucose Monitoring (CGM) Arm | Blood Glucose Monitoring (BGM) Arm | Total |
|---|---|---|---|
| Age, Continuous | 53.5 years STANDARD_DEVIATION 9.7 | 52.3 years STANDARD_DEVIATION 9.3 | 52.8 years STANDARD_DEVIATION 9.5 |
| Hb1ac | 8.1 percentage of glycated hemoglobin STANDARD_DEVIATION 1.2 | 8.1 percentage of glycated hemoglobin STANDARD_DEVIATION 1.2 | 8.1 percentage of glycated hemoglobin STANDARD_DEVIATION 1.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 13 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) White | 62 Participants | 59 Participants | 121 Participants |
| Sex: Female, Male Female | 41 Participants | 38 Participants | 79 Participants |
| Sex: Female, Male Male | 40 Participants | 44 Participants | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 81 | 0 / 82 |
| other Total, other adverse events | 0 / 81 | 0 / 82 |
| serious Total, serious adverse events | 0 / 81 | 0 / 82 |
Outcome results
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)
Time frame: Three (3) months
Population: Participants with adequate blinded CGM data at baseline and at month 3 were included.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Continuous Glucose Monitoring (CGM) Arm | Difference in Change in 14-day CGM-derived TIR From (3 Months Minus Baseline) | 28 percentage of time with glucose 70-180 m |
| Blood Glucose Monitoring (BGM) Arm | Difference in Change in 14-day CGM-derived TIR From (3 Months Minus Baseline) | 22 percentage of time with glucose 70-180 m |
Secondary
90-day Mean Blood Ketone Levels
Mean of blood ketone levels from day 0 to day 90 (three months).
Time frame: Three (3) months / 90 days
Population: Results from general and generalized linear mixed models using all available data
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Continuous Glucose Monitoring (CGM) Arm | 90-day Mean Blood Ketone Levels | 0.54 mmol/L |
| Blood Glucose Monitoring (BGM) Arm | 90-day Mean Blood Ketone Levels | 0.48 mmol/L |
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
Time frame: Three (3) months
Population: Some data missing at random; all available and qualifying data were used
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Continuous Glucose Monitoring (CGM) Arm | Difference in Change in HbA1c | -1.6 percentage of glycated hemoglobin |
| Blood Glucose Monitoring (BGM) Arm | Difference in Change in HbA1c | -1.5 percentage of glycated hemoglobin |
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
Time frame: Three (3) months
Population: Some data missing at random; used all available and qualifying data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Continuous Glucose Monitoring (CGM) Arm | Participants Reaching CGM-derived Consensus Targets | 81 percentage of participants |
| Blood Glucose Monitoring (BGM) Arm | Participants Reaching CGM-derived Consensus Targets | 66 percentage of participants |
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)
Time frame: Three (3) months
Population: Some data were missing at random; analysis used all available qualifying data
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Continuous Glucose Monitoring (CGM) Arm | Difference in Change in CGM-derived Metric %Time Above Range >180 mg/dL During 3-month Post-Dietary Change Period (3 Month Minus Baseline) | -28 percent time with glucose >180mg/dL |
| Blood Glucose Monitoring (BGM) Arm | Difference in Change in CGM-derived Metric %Time Above Range >180 mg/dL During 3-month Post-Dietary Change Period (3 Month Minus Baseline) | -23 percent time with glucose >180mg/dL |
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)
Time frame: Three (3) months (baseline to three months)
Population: some data missing at random; all available and qualifying data were used
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Continuous Glucose Monitoring (CGM) Arm | Difference in Change in the CGM-derived Metric, % Coefficient of Variation, From Baseline to 3-month Post-Dietary Change Period (3 Months Minus Baseline) | -4 percent of coefficient of variation |
| Blood Glucose Monitoring (BGM) Arm | Difference in Change in the CGM-derived Metric, % Coefficient of Variation, From Baseline to 3-month Post-Dietary Change Period (3 Months Minus Baseline) | -4 percent of coefficient of variation |
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
Time frame: Three (3) months (baseline to three months)
Population: some data missing at random; all available and qualifying data were used
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Continuous Glucose Monitoring (CGM) Arm | Difference in Change in the CGM-derived Metric, Mean Sensor Glucose, From Baseline to 3-month Post-Dietary Change Period (3 Months Minus Baseline) | -48 mg/dL |
| Blood Glucose Monitoring (BGM) Arm | Difference in Change in the CGM-derived Metric, Mean Sensor Glucose, From Baseline to 3-month Post-Dietary Change Period (3 Months Minus Baseline) | -42 mg/dL |
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)
Time frame: Three (3) months (baseline to three months)
Population: some data missing at random; all available and qualifying data were used
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Continuous Glucose Monitoring (CGM) Arm | 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) | -0.01 percent time with glucose <54 mg/dL |
| Blood Glucose Monitoring (BGM) Arm | 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) | 0.04 percent time with glucose <54 mg/dL |
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)
Time frame: 3 months (baseline to three months)
Population: some data missing at random; all available and qualifying data were used
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Continuous Glucose Monitoring (CGM) Arm | Difference in Change in the CGM-derived Metric, %Time Below Range <70 mg/dL (3 Months Minus Baseline) | 0.7 percent time with glucose <70mg/dL |
| Blood Glucose Monitoring (BGM) Arm | Difference in Change in the CGM-derived Metric, %Time Below Range <70 mg/dL (3 Months Minus Baseline) | 1.2 percent time with glucose <70mg/dL |