Trial Outcomes & Findings for Onduo Virtual Diabetes Clinic Study (NCT NCT03865381)
NCT ID: NCT03865381
Last Updated: 2021-09-24
Results Overview
Mean change in hemoglobin A1c from enrollment to 4 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
4 Months
Results posted on
2021-09-24
Participant Flow
Participant milestones
| Measure |
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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|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
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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|---|---|
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Overall Study
Protocol Violation/Non-Compliance
|
3
|
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Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Onduo Virtual Diabetes Clinic Study
Baseline characteristics by cohort
| Measure |
Virtual Diabetes Clinic
n=55 Participants
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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|---|---|
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Age, Continuous
|
57.3 Years
STANDARD_DEVIATION 11.6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
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Race/Ethnicity, Customized
White
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35 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White, American Indian or Alaska Native, Other
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
No, not of Hispanic, Latino/a, or Spanish origin
|
51 Participants
n=99 Participants
|
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Race/Ethnicity, Customized
Yes, of Hispanic, Latino/a, or Spanish origin
|
4 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
55 Participants
n=99 Participants
|
|
Weight
|
218.7 lb
STANDARD_DEVIATION 59.7 • n=99 Participants
|
|
BMI
|
33.7 kg/m^2
STANDARD_DEVIATION 7.2 • n=99 Participants
|
|
HbA1c
|
8.9 Percent (%)
STANDARD_DEVIATION 1.0 • n=99 Participants
|
|
Systolic Blood Pressure
|
132.1 mmHg
STANDARD_DEVIATION 15.8 • n=99 Participants
|
|
Diastolic Blood Pressure
|
80.7 mmHg
STANDARD_DEVIATION 10.4 • n=99 Participants
|
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Total Cholesterol
|
168.3 mg/dL
STANDARD_DEVIATION 42.8 • n=99 Participants
|
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HDL Cholesterol
|
40.4 mg/dL
STANDARD_DEVIATION 9.1 • n=99 Participants
|
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LDL Cholesterol
|
100.1 mg/dL
STANDARD_DEVIATION 36.5 • n=99 Participants
|
|
Non-HDL Cholesterol
|
128.0 mg/dL
STANDARD_DEVIATION 42.70 • n=99 Participants
|
|
Total Cholesterol/HDL Ratio
|
4.4 Ratio
STANDARD_DEVIATION 1.4 • n=99 Participants
|
|
Triglycerides
|
236.7 mg/dL
STANDARD_DEVIATION 194.3 • n=99 Participants
|
|
Diabetes Medications
0
|
0 Participants
n=99 Participants
|
|
Diabetes Medications
1
|
6 Participants
n=99 Participants
|
|
Diabetes Medications
2
|
21 Participants
n=99 Participants
|
|
Diabetes Medications
>=3
|
28 Participants
n=99 Participants
|
|
Type of Diabetes Medications
Alpha glucosidase inhibitor
|
1 Participants
n=99 Participants
|
|
Type of Diabetes Medications
Biguanide
|
46 Participants
n=99 Participants
|
|
Type of Diabetes Medications
DPP-4 inhibitor
|
10 Participants
n=99 Participants
|
|
Type of Diabetes Medications
GLP-1 analogue
|
14 Participants
n=99 Participants
|
|
Type of Diabetes Medications
Insulin
|
20 Participants
n=99 Participants
|
|
Type of Diabetes Medications
SGLT2 inhibitor
|
20 Participants
n=99 Participants
|
|
Type of Diabetes Medications
Sulfonylurea
|
30 Participants
n=99 Participants
|
|
Type of Diabetes Medications
Thiazolidinedione
|
2 Participants
n=99 Participants
|
|
Type of Diabetes Medications
Lipid-lowering medications
|
44 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 4 MonthsMean change in hemoglobin A1c from enrollment to 4 months
Outcome measures
| Measure |
Virtual Diabetes Clinic
n=55 Participants
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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Mean Change in Hemoglobin A1c
|
-1.6 Percent (%)
Standard Deviation 1
|
SECONDARY outcome
Timeframe: 4 MonthsChange in weight from enrollment to 4 months
Outcome measures
| Measure |
Virtual Diabetes Clinic
n=54 Participants
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.
|
|---|---|
|
Change in Weight From Enrollment
|
-9.0 lb
Standard Deviation 10.4
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SECONDARY outcome
Timeframe: 4 MonthsChange in diabetes medication or dosage from enrollment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 MonthsMean glucose was calculated from an initial wear period to a final wear period.
Outcome measures
| Measure |
Virtual Diabetes Clinic
n=43 Participants
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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Change in Mean Glucose From the First Wear Period Versus the Final Wear Period.
|
-14.6 mg/dL
Standard Deviation 27.5
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SECONDARY outcome
Timeframe: 4 MonthsCoefficient of variation was calculated from an initial wear period to a final wear period.
Outcome measures
| Measure |
Virtual Diabetes Clinic
n=43 Participants
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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Change in Glycemic Variability From the First Wear Period Versus the Final Wear Period.
|
-1.6 Percent (%)
Standard Deviation 4.5
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SECONDARY outcome
Timeframe: 4 MonthsPercent time in Glycemic Range, 70 to 180 mg/dL, was calculated from an initial wear period to a final wear period.
Outcome measures
| Measure |
Virtual Diabetes Clinic
n=43 Participants
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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Change in Time Spent in Glycemic Range From the First Wear Period Versus the Final Wear Period.
|
10.2 Percent (%)
Standard Deviation 20.5
|
SECONDARY outcome
Timeframe: 4 MonthsMean change in estimated A1c between the first and second CGM wear periods, where estimated A1c is a linear function of average blood glucose.
Outcome measures
Outcome data not reported
Adverse Events
Virtual Diabetes Clinic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place