N/A
Completed N=60
Onduo Virtual Diabetes Clinic Study
Source: ClinicalTrials.gov NCT03865381 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcomePrimary: Mean Change in Hemoglobin A1c — -1.6 Percent (%)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Hemoglobin A1c |
-1.6 | — |
| SECONDARY Change in Weight From Enrollment |
-9.0 | — |
| SECONDARY Time to First Change in Diabetes Medication or Dosage From Enrollment |
— | — |
| SECONDARY Change in Mean Glucose From the First Wear Period Versus the Final Wear Period. |
-14.6 | — |
| SECONDARY Change in Glycemic Variability From the First Wear Period Versus the Final Wear Period. |
-1.6 | — |
| SECONDARY Change in Time Spent in Glycemic Range From the First Wear Period Versus the Final Wear Period. |
10.2 | — |
| SECONDARY Mean Change in A1c |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03865381). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.