Type 2 Diabetes
Conditions
Brief summary
The objective of this study is to evaluate the feasibility and clinical utility of a continuous glucose monitoring device (CGM, Dexcom G6) for the care of patients with type 2 diabetes who are on non-insulin therapies.
Detailed description
The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system. This investigation is a 2-phase sequential study with patients serving as their own controls. The demographics, medical history, anthropometric and laboratory data are collected at baseline for each patient. During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention. During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. Anthropometric and laboratory data (including HB A1c) are collected. Medical providers are also un-blinded and adjust medical recommendations and interventions, in part based on CGM data, as appropriate. All patients will receive usual care which will include individual and virtual lifestyle education, virtual support group, M.D. visits, medication interventions, referrals to support programs outside the scope of CINEMA program and nursing support
Interventions
The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.
Sponsors
DexCom, Inc.
Ian J. Neeland, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
The device is used in blinded mode where both patient and provider are blinded to the data only during Phase 1.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes of any duration * Hb A1c ≥ 7% (no upper limit) * BMI ≥ 30 kg/m2 * Ability to wear CGM (e.g. no dermatological issue precluding device insertion) * Access to a smartphone device
Exclusion criteria
* Any insulin use in the past 3 months * Planned use of insulin in the next 6 months * Presence of a blood disorder (such as sickle cell anemia) making glycosylated hemoglobin measurement inaccurate * Current use of a weight loss medication * Unable or uncomfortable with wearing a CGM device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average Glucose Levels as Measured by Continuous Glucose Monitor | 0, 30, 60, 90 days | Average glucose on CGM |
| Change in Time in Range as Measured by Continuous Glucose Monitor | 0, 30, 60, 90 days | Time in range is the time spent in the acceptable glucose range between 80-180 mg/dl. This time in range is noted as a proportion of time that the blood glucose is in this range out of the total time. So if the person's glucose is in this range 70% of the time (and out of it 30%), then Time in Range is 70%. |
| Change in Glucose Variability as Measured by Continuous Glucose Monitor | 0, 30, 60, 90 days | Glucose variability on CGM is defined as standard deviation of the all recorded glucose values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in High Density Lipoprotein Cholesterol From Blood Test | 0 and 90 days | HDL-C |
| Change in Triglycerides From Blood Test | 0 and 90 days | Triglycerides |
| Change in Body Mass Index From Height and Weight | 0 and 90 days | BMI |
| Change in Systolic Blood Pressure From Automated Cuff | 0 and 90 days | Systolic blood pressure |
| Change in Hemoglobin A1c From Blood Test | 0 and 90 days | Glycosylated hemoglobin |
| Picture Your Plate Dietary Assessment Questionnaire | 0, 90 days | Picture Your PlateTM is a brief (48-question) dietary assessment questionnaire developed to assess how well an individual's eating habits align with current evidence-based recommendations. Picture Your Plate provides a total score ranging from 0 to 96, with a higher score indicating healthier food choice awareness. |
| Type 2 Diabetes Distress Screening Scale (T2-DDAS) | 0, 90 days | The T2-DDAS is a self-report survey that has 29 items. Each item rated on a 1 to 5 scale: Mean score \< 2.0 indicate little or no distress. Mean score between 2.0 and 2.9 indicate moderate distress. Mean score \> 3.0 indicate high distress |
| International Physical Activity Questionnaire (IPAQ) | 0, 90 days | The International Physical Activity Questionnaires (IPAQ) comprises a set of 4 questionnaires. Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. This measure assesses the types of intensity of physical activity that people do as part of their daily lives. The estimate is measured as total physical activity in MET-min/week. Lower scores mean less total amount and intensity of physical activity and higher scores mean greater total amount and intensity of physical activity in a given week. |
| Glucose Monitoring Satisfaction Survey | 90 days | The GMSS is a reliable, valid measure of glucose device satisfaction in its T1D form and in its insulin-using T2D form. It provides a comprehensive profile of sources of device satisfaction for use in clinical care and research. |
| Change in Diastolic Blood Pressure From Automated Cuff | 0 and 90 days | Diastolic blood pressure |
| Change in Total Cholesterol From Blood Test | 0 and 90 days | Total cholesterol |
| Change in Low Density Lipoprotein Cholesterol From Blood Test | 0 and 90 days | LDL-C |
Countries
United States
Participant flow
Pre-assignment details
2 people did not meet eligibility criteria. They were consented but did not participate in the study. A total of 56 participants signed consents and only 47 fully completed both phases of the study.
Participants by arm
| Arm | Count |
|---|---|
| Blinded Followed by Unblinded During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention.
During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase.
Dexcom continuous glucose monitor: The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system. | 56 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Phase 1- Blinded (10 Days) | did not meet eligibility criteria | 2 |
| Phase 1- Blinded (10 Days) | High stress, did not want to continue | 1 |
| Phase 1- Blinded (10 Days) | Technical issues with device | 4 |
| Phase 1- Blinded (10 Days) | Unable to contact | 2 |
Baseline characteristics
| Characteristic | Blinded Followed by Unblinded |
|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 9.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 32 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 47 |
| other Total, other adverse events | 0 / 56 | 0 / 47 |
| serious Total, serious adverse events | 0 / 56 | 0 / 47 |
Outcome results
Primary
Change in Average Glucose Levels as Measured by Continuous Glucose Monitor
Average glucose on CGM
Time frame: 0, 30, 60, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blinded Followed by Unblinded | Change in Average Glucose Levels as Measured by Continuous Glucose Monitor | Day 0 | 184 mg/dl | Standard Deviation 55.7 |
| Blinded Followed by Unblinded | Change in Average Glucose Levels as Measured by Continuous Glucose Monitor | Day 30 | 148.6 mg/dl | Standard Deviation 45.4 |
| Blinded Followed by Unblinded | Change in Average Glucose Levels as Measured by Continuous Glucose Monitor | Day 60 | 144.8 mg/dl | Standard Deviation 45.3 |
| Blinded Followed by Unblinded | Change in Average Glucose Levels as Measured by Continuous Glucose Monitor | Day 90 | 147.2 mg/dl | Standard Deviation 44.7 |
Primary
Change in Glucose Variability as Measured by Continuous Glucose Monitor
Glucose variability on CGM is defined as standard deviation of the all recorded glucose values.
Time frame: 0, 30, 60, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blinded Followed by Unblinded | Change in Glucose Variability as Measured by Continuous Glucose Monitor | Day 0 | 26.2 mg/dl | Standard Deviation 8.9 |
| Blinded Followed by Unblinded | Change in Glucose Variability as Measured by Continuous Glucose Monitor | Day 30 | 24.1 mg/dl | Standard Deviation 7.5 |
| Blinded Followed by Unblinded | Change in Glucose Variability as Measured by Continuous Glucose Monitor | Day 60 | 24.1 mg/dl | Standard Deviation 7.7 |
| Blinded Followed by Unblinded | Change in Glucose Variability as Measured by Continuous Glucose Monitor | Day 90 | 24 mg/dl | Standard Deviation 6.6 |
Primary
Change in Time in Range as Measured by Continuous Glucose Monitor
Time in range is the time spent in the acceptable glucose range between 80-180 mg/dl. This time in range is noted as a proportion of time that the blood glucose is in this range out of the total time. So if the person's glucose is in this range 70% of the time (and out of it 30%), then Time in Range is 70%.
Time frame: 0, 30, 60, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blinded Followed by Unblinded | Change in Time in Range as Measured by Continuous Glucose Monitor | Day 0 | 57.8 percentage of time in range | Standard Deviation 32.5 |
| Blinded Followed by Unblinded | Change in Time in Range as Measured by Continuous Glucose Monitor | Day 30 | 82 percentage of time in range | Standard Deviation 22.7 |
| Blinded Followed by Unblinded | Change in Time in Range as Measured by Continuous Glucose Monitor | Day 60 | 83.8 percentage of time in range | Standard Deviation 23.8 |
| Blinded Followed by Unblinded | Change in Time in Range as Measured by Continuous Glucose Monitor | Day 90 | 82.5 percentage of time in range | Standard Deviation 24.6 |
Secondary
Change in Body Mass Index From Height and Weight
BMI
Time frame: 0 and 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blinded Followed by Unblinded | Change in Body Mass Index From Height and Weight | Day 0 | 37.7 kg/m2 | Standard Deviation 6.1 |
| Blinded Followed by Unblinded | Change in Body Mass Index From Height and Weight | Day 90 | 34.9 kg/m2 | Standard Deviation 5.9 |
Secondary
Change in Diastolic Blood Pressure From Automated Cuff
Diastolic blood pressure
Time frame: 0 and 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blinded Followed by Unblinded | Change in Diastolic Blood Pressure From Automated Cuff | Day 0 | 79.4 mmHg | Standard Deviation 6.7 |
| Blinded Followed by Unblinded | Change in Diastolic Blood Pressure From Automated Cuff | Day 90 | 75.8 mmHg | Standard Deviation 7.3 |
Secondary
Change in Hemoglobin A1c From Blood Test
Glycosylated hemoglobin
Time frame: 0 and 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blinded Followed by Unblinded | Change in Hemoglobin A1c From Blood Test | Day 0 | 8.4 percentage of Glycosylated hemoglobin | Standard Deviation 1.8 |
| Blinded Followed by Unblinded | Change in Hemoglobin A1c From Blood Test | Day 90 | 6.9 percentage of Glycosylated hemoglobin | Standard Deviation 1.2 |
Secondary
Change in High Density Lipoprotein Cholesterol From Blood Test
HDL-C
Time frame: 0 and 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blinded Followed by Unblinded | Change in High Density Lipoprotein Cholesterol From Blood Test | Day 0 | 45.5 mg/dl | Standard Deviation 12.4 |
| Blinded Followed by Unblinded | Change in High Density Lipoprotein Cholesterol From Blood Test | Day 90 | 43.9 mg/dl | Standard Deviation 10.5 |
Secondary
Change in Low Density Lipoprotein Cholesterol From Blood Test
LDL-C
Time frame: 0 and 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blinded Followed by Unblinded | Change in Low Density Lipoprotein Cholesterol From Blood Test | Day 0 | 82.8 mg/dl | Standard Deviation 37 |
| Blinded Followed by Unblinded | Change in Low Density Lipoprotein Cholesterol From Blood Test | Day 90 | 73.6 mg/dl | Standard Deviation 38.5 |
Secondary
Change in Systolic Blood Pressure From Automated Cuff
Systolic blood pressure
Time frame: 0 and 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blinded Followed by Unblinded | Change in Systolic Blood Pressure From Automated Cuff | Day 0 | 134.8 mmHg | Standard Deviation 16.3 |
| Blinded Followed by Unblinded | Change in Systolic Blood Pressure From Automated Cuff | Day 90 | 126.0 mmHg | Standard Deviation 15.2 |
Secondary
Change in Total Cholesterol From Blood Test
Total cholesterol
Time frame: 0 and 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blinded Followed by Unblinded | Change in Total Cholesterol From Blood Test | Day 0 | 162.6 mg/dl | Standard Deviation 45.6 |
| Blinded Followed by Unblinded | Change in Total Cholesterol From Blood Test | Day 90 | 143.6 mg/dl | Standard Deviation 45.2 |
Secondary
Change in Triglycerides From Blood Test
Triglycerides
Time frame: 0 and 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blinded Followed by Unblinded | Change in Triglycerides From Blood Test | Day 0 | 173.3 mg/dl | Standard Deviation 110.4 |
| Blinded Followed by Unblinded | Change in Triglycerides From Blood Test | Day 90 | 131.2 mg/dl | Standard Deviation 69.7 |
Secondary
Glucose Monitoring Satisfaction Survey
The GMSS is a reliable, valid measure of glucose device satisfaction in its T1D form and in its insulin-using T2D form. It provides a comprehensive profile of sources of device satisfaction for use in clinical care and research.
Time frame: 90 days
Population: No data was collected.
Secondary
International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaires (IPAQ) comprises a set of 4 questionnaires. Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. This measure assesses the types of intensity of physical activity that people do as part of their daily lives. The estimate is measured as total physical activity in MET-min/week. Lower scores mean less total amount and intensity of physical activity and higher scores mean greater total amount and intensity of physical activity in a given week.
Time frame: 0, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blinded Followed by Unblinded | International Physical Activity Questionnaire (IPAQ) | Day 0 | 2864.8 minutes per week | Standard Deviation 3329 |
| Blinded Followed by Unblinded | International Physical Activity Questionnaire (IPAQ) | Day 90 | 3445.4 minutes per week | Standard Deviation 3040 |
Secondary
Picture Your Plate Dietary Assessment Questionnaire
Picture Your PlateTM is a brief (48-question) dietary assessment questionnaire developed to assess how well an individual's eating habits align with current evidence-based recommendations. Picture Your Plate provides a total score ranging from 0 to 96, with a higher score indicating healthier food choice awareness.
Time frame: 0, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blinded Followed by Unblinded | Picture Your Plate Dietary Assessment Questionnaire | Day 0 | 61 score on a scale | Standard Deviation 12.4 |
| Blinded Followed by Unblinded | Picture Your Plate Dietary Assessment Questionnaire | Day 90 | 65.5 score on a scale | Standard Deviation 17.7 |
Secondary
Type 2 Diabetes Distress Screening Scale (T2-DDAS)
The T2-DDAS is a self-report survey that has 29 items. Each item rated on a 1 to 5 scale: Mean score \< 2.0 indicate little or no distress. Mean score between 2.0 and 2.9 indicate moderate distress. Mean score \> 3.0 indicate high distress
Time frame: 0, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blinded Followed by Unblinded | Type 2 Diabetes Distress Screening Scale (T2-DDAS) | Day 0 | 2.4 score on a scale | Standard Deviation 0.9 |
| Blinded Followed by Unblinded | Type 2 Diabetes Distress Screening Scale (T2-DDAS) | Day 90 | 1.6 score on a scale | Standard Deviation 0.5 |