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This is a prospective, single arm study designed to evaluate the change in hemoglobin A1c after 4 months of participation in the Onduo Virtual Diabetes Clinic (VDC) in individuals with Type 2 diabetes and suboptimal glycemic control.
The Onduo Virtual Diabetes Clinic (VDC) is the suite of diabetes management services accessed via a software application (Onduo App).
Eligible subjects are asked to use the Onduo App and commercially available FDA-regulated medical devices and non-medical devices, for up to 4 months.
Subjects receive a continuous glucose monitor (CGM) and are asked to use the device for up to 6 wear cycles of 10 days each.
Subjects are scheduled for a medical review via a face-to-face telemedicine consultation with a VDC Physician.
Subjects may have their diabetes medications changed by a VDC Physician following their telemedicine visit.
Information provided to a subject in the course of the study is not intended as a substitute for the subject's primary care provider's guidance.
At the completion of the subject's study participation, the Onduo App will be deactivated and there will be no further data collection through the app.
A1c levels and surveys are collected at 1 year follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Diabetes Clinic | Other | The Onduo Virtual Diabetes Clinic (VDC) is the suite of diabetes management services including remote monitoring, diet/lifestyle coaching, medication management accessed via Onduo App and partner apps. Subjects will engage with a Care Lead through the App and will have a medical consultation via telemedicine with an Onduo VDC Physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Onduo App | Device | The Onduo App is a software application which tracks data relevant to diabetes care, such as, but not limited to, medication, meal logs and glucose readings, and activity data. The Onduo App connects wirelessly to a Care Team Console through the Internet. The Onduo App may also connect wirelessly to commercially available FDA-regulated (i.e., cleared and approved) medical devices and non-medical devices through the subject's Smartphone. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Hemoglobin A1c | Mean change in hemoglobin A1c from enrollment to 4 months | 4 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight From Enrollment | Change in weight from enrollment to 4 months | 4 Months |
| Time to First Change in Diabetes Medication or Dosage From Enrollment | Change in diabetes medication or dosage from enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amit Majithia, MD | Onduo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palo Alto Medical Foundation | Palo Alto | California | 94301 | United States | ||
| Premier Medical Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35147501 | Derived | Majithia AR, Erani DM, Kusiak CM, Layne JE, Lee AA, Colangelo FR, Romanelli RJ, Robertson S, Brown SM, Dixon RF, Zisser H. Medication Optimization Among People With Type 2 Diabetes Participating in a Continuous Glucose Monitoring-Driven Virtual Care Program: Prospective Study. JMIR Form Res. 2022 Apr 5;6(4):e31629. doi: 10.2196/31629. | |
| 32856597 |
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There is not a plan to make IPD available.
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| ID | Title | Description |
|---|---|---|
| FG000 | Virtual Diabetes Clinic | The Onduo Virtual Diabetes Clinic (VDC) is the suite of diabetes management services including remote monitoring, diet/lifestyle coaching, medication management accessed via Onduo App and partner apps. Subjects will engage with a Care Lead through the App and will have a medical consultation via telemedicine with an Onduo VDC Physician. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Virtual Diabetes Clinic | The Onduo Virtual Diabetes Clinic (VDC) is the suite of diabetes management services including remote monitoring, diet/lifestyle coaching, medication management accessed via Onduo App and partner apps. Subjects will engage with a Care Lead through the App and will have a medical consultation via telemedicine with an Onduo VDC Physician. |
| 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 | Mean Change in Hemoglobin A1c | Mean change in hemoglobin A1c from enrollment to 4 months | Posted | Mean | Standard Deviation | Percent (%) | 4 Months |
|
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4 months
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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 | Virtual Diabetes Clinic | The Onduo Virtual Diabetes Clinic (VDC) is the suite of diabetes management services including remote monitoring, diet/lifestyle coaching, medication management accessed via Onduo App and partner apps. Subjects will engage with a Care Lead through the App and will have a medical consultation via telemedicine with an Onduo VDC Physician. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Science | Verily Life Sciences | (650) 253-0000 | info@verily.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 | Apr 9, 2019 | May 28, 2021 | 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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|
| 4 Months |
| Change in Mean Glucose From the First Wear Period Versus the Final Wear Period. | Mean glucose was calculated from an initial wear period to a final wear period. | 4 Months |
| Change in Glycemic Variability From the First Wear Period Versus the Final Wear Period. | Coefficient of variation was calculated from an initial wear period to a final wear period. | 4 Months |
| Change in Time Spent in Glycemic Range From the First Wear Period Versus the Final Wear Period. | Percent time in Glycemic Range, 70 to 180 mg/dL, was calculated from an initial wear period to a final wear period. | 4 Months |
| Mean Change in A1c | Mean change in estimated A1c between the first and second CGM wear periods, where estimated A1c is a linear function of average blood glucose. | 4 Months |
| Monroeville |
| Pennsylvania |
| 15146 |
| United States |
| Majithia AR, Kusiak CM, Armento Lee A, Colangelo FR, Romanelli RJ, Robertson S, Miller DP, Erani DM, Layne JE, Dixon RF, Zisser H. Glycemic Outcomes in Adults With Type 2 Diabetes Participating in a Continuous Glucose Monitor-Driven Virtual Diabetes Clinic: Prospective Trial. J Med Internet Res. 2020 Aug 28;22(8):e21778. doi: 10.2196/21778. |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | lb |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| HbA1c | Mean | Standard Deviation | Percent (%) |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| Total Cholesterol | Mean | Standard Deviation | mg/dL |
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| HDL Cholesterol | Mean | Standard Deviation | mg/dL |
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| LDL Cholesterol | Mean | Standard Deviation | mg/dL |
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| Non-HDL Cholesterol | Mean | Standard Deviation | mg/dL |
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| Total Cholesterol/HDL Ratio | Mean | Standard Deviation | Ratio |
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| Triglycerides | Mean | Standard Deviation | mg/dL |
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| Diabetes Medications | Count of Participants | Participants |
|
| Type of Diabetes Medications | Count of Participants | Participants |
|
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| Secondary | Change in Weight From Enrollment | Change in weight from enrollment to 4 months | Posted | Mean | Standard Deviation | lb | 4 Months |
|
|
|
| Secondary | Time to First Change in Diabetes Medication or Dosage From Enrollment | Change in diabetes medication or dosage from enrollment | Not Posted | 4 Months | Participants |
| Secondary | Change in Mean Glucose From the First Wear Period Versus the Final Wear Period. | Mean glucose was calculated from an initial wear period to a final wear period. | Posted | Mean | Standard Deviation | mg/dL | 4 Months |
|
|
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| Secondary | Change in Glycemic Variability From the First Wear Period Versus the Final Wear Period. | Coefficient of variation was calculated from an initial wear period to a final wear period. | Posted | Mean | Standard Deviation | Percent (%) | 4 Months |
|
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| Secondary | Change in Time Spent in Glycemic Range From the First Wear Period Versus the Final Wear Period. | Percent time in Glycemic Range, 70 to 180 mg/dL, was calculated from an initial wear period to a final wear period. | Posted | Mean | Standard Deviation | Percent (%) | 4 Months |
|
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| Secondary | Mean Change in A1c | Mean change in estimated A1c between the first and second CGM wear periods, where estimated A1c is a linear function of average blood glucose. | Not Posted | 4 Months | Participants |
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| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
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| D004700 | Endocrine System Diseases |