Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEOnduo App
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.
Sponsors
Verily Life Sciences LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and Female; 18 years of age or older * Confirmed diagnosis of Type 2 diabetes mellitus * Willing to use CGM and BGM * A1c result ≥8.0% and ≤12.0% * Receive their diabetes care from Premier Medical Associates or the Palo Alto Medical Foundation * Own a Smartphone with a data plan and be the primary user of that smartphone * Smartphone must use a supported Android OS or iOS
Exclusion criteria
* Pregnant or breastfeeding * Use of an insulin pump * Any condition or situation that the Sponsor or Investigator determines as inappropriate for study inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Hemoglobin A1c | 4 Months | Mean change in hemoglobin A1c from enrollment to 4 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight From Enrollment | 4 Months | Change in weight from enrollment to 4 months |
| Time to First Change in Diabetes Medication or Dosage From Enrollment | 4 Months | Change in diabetes medication or dosage from enrollment |
| Change in Mean Glucose From the First Wear Period Versus the Final Wear Period. | 4 Months | Mean glucose was calculated from an initial wear period to a final wear period. |
| Change in Glycemic Variability From the First Wear Period Versus the Final Wear Period. | 4 Months | Coefficient of variation was calculated from an initial wear period to a final wear period. |
| Change in Time Spent in Glycemic Range From the First Wear Period Versus the Final Wear Period. | 4 Months | Percent time in Glycemic Range, 70 to 180 mg/dL, was calculated from an initial wear period to a final wear period. |
| Mean Change in A1c | 4 Months | Mean change in estimated A1c between the first and second CGM wear periods, where estimated A1c is a linear function of average blood glucose. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 55 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation/Non-Compliance | 3 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Virtual Diabetes Clinic |
|---|---|
| Age, Continuous | 57.3 Years STANDARD_DEVIATION 11.6 |
| BMI | 33.7 kg/m^2 STANDARD_DEVIATION 7.2 |
| Diabetes Medications 0 | 0 Participants |
| Diabetes Medications 1 | 6 Participants |
| Diabetes Medications 2 | 21 Participants |
| Diabetes Medications >=3 | 28 Participants |
| Diastolic Blood Pressure | 80.7 mmHg STANDARD_DEVIATION 10.4 |
| HbA1c | 8.9 Percent (%) STANDARD_DEVIATION 1 |
| HDL Cholesterol | 40.4 mg/dL STANDARD_DEVIATION 9.1 |
| LDL Cholesterol | 100.1 mg/dL STANDARD_DEVIATION 36.5 |
| Non-HDL Cholesterol | 128.0 mg/dL STANDARD_DEVIATION 42.7 |
| Race/Ethnicity, Customized Asian | 9 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants |
| Race/Ethnicity, Customized No, not of Hispanic, Latino/a, or Spanish origin | 51 Participants |
| Race/Ethnicity, Customized Other | 4 Participants |
| Race/Ethnicity, Customized White | 35 Participants |
| Race/Ethnicity, Customized White, American Indian or Alaska Native, Other | 1 Participants |
| Race/Ethnicity, Customized Yes, of Hispanic, Latino/a, or Spanish origin | 4 Participants |
| Region of Enrollment United States | 55 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 33 Participants |
| Systolic Blood Pressure | 132.1 mmHg STANDARD_DEVIATION 15.8 |
| Total Cholesterol | 168.3 mg/dL STANDARD_DEVIATION 42.8 |
| Total Cholesterol/HDL Ratio | 4.4 Ratio STANDARD_DEVIATION 1.4 |
| Triglycerides | 236.7 mg/dL STANDARD_DEVIATION 194.3 |
| Type of Diabetes Medications Alpha glucosidase inhibitor | 1 Participants |
| Type of Diabetes Medications Biguanide | 46 Participants |
| Type of Diabetes Medications DPP-4 inhibitor | 10 Participants |
| Type of Diabetes Medications GLP-1 analogue | 14 Participants |
| Type of Diabetes Medications Insulin | 20 Participants |
| Type of Diabetes Medications Lipid-lowering medications | 44 Participants |
| Type of Diabetes Medications SGLT2 inhibitor | 20 Participants |
| Type of Diabetes Medications Sulfonylurea | 30 Participants |
| Type of Diabetes Medications Thiazolidinedione | 2 Participants |
| Weight | 218.7 lb STANDARD_DEVIATION 59.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 55 |
| other Total, other adverse events | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 |
Outcome results
Primary
Mean Change in Hemoglobin A1c
Mean change in hemoglobin A1c from enrollment to 4 months
Time frame: 4 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Diabetes Clinic | Mean Change in Hemoglobin A1c | -1.6 Percent (%) | Standard Deviation 1 |
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.
Time frame: 4 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Diabetes Clinic | Change in Glycemic Variability From the First Wear Period Versus the Final Wear Period. | -1.6 Percent (%) | Standard Deviation 4.5 |
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.
Time frame: 4 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Diabetes Clinic | Change in Mean Glucose From the First Wear Period Versus the Final Wear Period. | -14.6 mg/dL | Standard Deviation 27.5 |
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.
Time frame: 4 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Diabetes Clinic | 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
Change in Weight From Enrollment
Change in weight from enrollment to 4 months
Time frame: 4 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Diabetes Clinic | Change in Weight From Enrollment | -9.0 lb | Standard Deviation 10.4 |
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.
Time frame: 4 Months
Secondary
Time to First Change in Diabetes Medication or Dosage From Enrollment
Change in diabetes medication or dosage from enrollment
Time frame: 4 Months