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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blinded followed by Unblinded | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom continuous glucose monitor | Device | The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average Glucose Levels as Measured by Continuous Glucose Monitor | Average glucose on CGM | 0, 30, 60, 90 days |
| 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%. | 0, 30, 60, 90 days |
| 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. | 0, 30, 60, 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c From Blood Test | Glycosylated hemoglobin | 0 and 90 days |
| Change in Total Cholesterol From Blood Test | Total cholesterol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Neeland, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38680050 | Derived | Reed J, Dong T, Eaton E, Friswold J, Porges J, Al-Kindi SG, Rajagopalan S, Neeland IJ. Continuous glucose monitoring for glycaemic control and cardiovascular risk reduction in patients with type 2 diabetes not on insulin therapy: A clinical trial. Diabetes Obes Metab. 2024 Jul;26(7):2881-2889. doi: 10.1111/dom.15608. Epub 2024 Apr 28. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexcom G6 Continuous Glucose Monitoring Device | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1- Blinded (10 Days) |
|
| ||||||||||||||||||||||||
| Phase 2- Unblinded (3 Months) |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | Change in Average Glucose Levels as Measured by Continuous Glucose Monitor | Average glucose on CGM | Posted | Mean | Standard Deviation | mg/dl | 0, 30, 60, 90 days |
|
From Baseline through end of the Unblinded Phase, approximately 100 days
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.
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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 | Blinded | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ian Neeland | University Hospitals Cleveland Medical Center | (216)844-5965 | Ian.Neeland@UHhospitals.org |
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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 | Dec 7, 2022 | Apr 19, 2024 | Prot_SAP_000.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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The device is used in blinded mode where both patient and provider are blinded to the data only during Phase 1.
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| 0 and 90 days |
| Change in Low Density Lipoprotein Cholesterol From Blood Test | LDL-C | 0 and 90 days |
| Change in High Density Lipoprotein Cholesterol From Blood Test | HDL-C | 0 and 90 days |
| Change in Triglycerides From Blood Test | Triglycerides | 0 and 90 days |
| Change in Body Mass Index From Height and Weight | BMI | 0 and 90 days |
| Change in Systolic Blood Pressure From Automated Cuff | Systolic blood pressure | 0 and 90 days |
| Change in Diastolic Blood Pressure From Automated Cuff | Diastolic blood pressure | 0 and 90 days |
| 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. | 0, 90 days |
| 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 | 0, 90 days |
| 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. | 0, 90 days |
| 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. | 90 days |
| did not meet eligibility criteria |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 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%. | Posted | Mean | Standard Deviation | percentage of time in range | 0, 30, 60, 90 days |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mg/dl | 0, 30, 60, 90 days |
|
|
|
| Secondary | Change in Hemoglobin A1c From Blood Test | Glycosylated hemoglobin | Posted | Mean | Standard Deviation | percentage of Glycosylated hemoglobin | 0 and 90 days |
|
|
|
| Secondary | Change in Total Cholesterol From Blood Test | Total cholesterol | Posted | Mean | Standard Deviation | mg/dl | 0 and 90 days |
|
|
|
| Secondary | Change in Low Density Lipoprotein Cholesterol From Blood Test | LDL-C | Posted | Mean | Standard Deviation | mg/dl | 0 and 90 days |
|
|
|
| Secondary | Change in High Density Lipoprotein Cholesterol From Blood Test | HDL-C | Posted | Mean | Standard Deviation | mg/dl | 0 and 90 days |
|
|
|
| Secondary | Change in Triglycerides From Blood Test | Triglycerides | Posted | Mean | Standard Deviation | mg/dl | 0 and 90 days |
|
|
|
| Secondary | Change in Body Mass Index From Height and Weight | BMI | Posted | Mean | Standard Deviation | kg/m2 | 0 and 90 days |
|
|
|
| Secondary | Change in Systolic Blood Pressure From Automated Cuff | Systolic blood pressure | Posted | Mean | Standard Deviation | mmHg | 0 and 90 days |
|
|
|
| Secondary | Change in Diastolic Blood Pressure From Automated Cuff | Diastolic blood pressure | Posted | Mean | Standard Deviation | mmHg | 0 and 90 days |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 0, 90 days |
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 0, 90 days |
|
|
|
| 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. | Posted | Mean | Standard Deviation | minutes per week | 0, 90 days |
|
|
|
| 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. | No data was collected. | Posted | 90 days |
|
|
| 0 |
| 56 |
| 0 |
| 56 |
| 0 |
| 56 |
| EG001 | Unblinded | 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. | 0 | 47 | 0 | 47 | 0 | 47 |
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| D004700 | Endocrine System Diseases |
| Title | Measurements |
|---|---|
|
| Day 90 |
|
| Title | Measurements |
|---|---|
|
| Day 90 |
|