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NCT05161793 · ClinicalTrials.gov registry record
Telemedicine Continuous Remote Monitoring of Adults With Uncontrolled Diabetes Mellitus
A clinical trial, sponsored by University of Southern California.
- Completed
- Registry status
- 200
- Enrollment target
NCT05161793: Completed study, sponsored by University of Southern California.
NCT05161793 is a clinical trial that has completed, run by University of Southern California. The registered enrollment target is 200 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05161793 has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- 200 participants
- Enrollment target
Study Summary
The purpose of this single center observational study is to determine the effect of continuous remote continuous glucose monitor (CGM) reporting coupled with a telemedicine intervention (Tele-CGM program) on levels of HbA1C in adults with poorly controlled type 1 or type 2 diabetes. The investigators will follow 200 English and Spanish speaking adults (125 type 2 and 75 type 1 patients) who have an HbA1C \>8% over 12 months. The primary analysis will follow the intention-to-treat principle; participants will all be offered the intervention. The primary trial outcome of HbA1c/Glucose Management Indicator (GMI) at 6 and 12 months will be compared from baseline using a linear regression model. The primary independent variable will be the HbA1C from baseline to 6 and 12 months. Patients will serve as their own control. Results will be summarized as group-specific mean, standard deviation (SD) HbA1c, along with a mean treatment difference and 95% confidence interval. Model assumptions including normality and homoscedasticity of residuals will be evaluated; normalizing transformations or rank-based non-parametric procedures will be used as needed. The complete evaluation of HbA1c, including baseline, 6-month and 12 month measurements will be analyzed with mixed effects linear regression, specifying a random participant-level intercept and an unstructured covariance matrix, to accommodate the repeatedly measured data. The secondary trial outcomes of time in range (TIR; CGM glucose levels 70-180) and questionnaires will be compared from baseline to 6 and 12 months using linear regression procedures as detailed above.
Primary Outcome
Number of patients with decreased HbA1c as measured by point of care HbA1c level from baseline to 12 months.
Interventions
- DEVICE Tele-Monitor DM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2022-05-01 |
| Est. Completion | 2025-05-31 |
What the finished NCT05161793 record still lists
NCT05161793 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Tele-Monitor DM is the first listed.
NCT05161793 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05161793 about?
NCT05161793 is a clinical study titled "Telemedicine Continuous Remote Monitoring of Adults With Uncontrolled Diabetes Mellitus". The purpose of this single center observational study is to determine the effect of continuous remote continuous glucose monitor (CGM) reporting coupled with a telemedicine intervention (Tele-CGM program) on levels of HbA1C in adults with poorly controlled type 1 or type 2 diabetes. The investigator...
What is the current status of trial NCT05161793?
This trial is currently completed. The enrollment target is 200 participants. The study started on 2022-05-01. Estimated completion is 2025-05-31.
What interventions are being tested in trial NCT05161793?
The interventions under investigation include: Tele-Monitor DM (DEVICE).
Who is sponsoring clinical trial NCT05161793?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
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