NCT05161793Completed
Telemedicine Continuous Remote Monitoring of Adults With Uncontrolled Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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 type 1 or type 2 diabetes. The investigators will follow 200 English and Spanish speaking adults (125 type 2 and 75 type 1 patients) 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. Once completed, study participants will have the opportunity to enter a study extension for an additional 12 months.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 230 (actual)
- First submitted
- 3 Dec 2021
- Start date
- 1 May 2022
- Primary completion date
- 31 Jan 2025
- Lead sponsor
- University of Southern California
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT05161793
What you commit to
- Study type: Observational
- Participants enrolled: 230
- From 1 May 2022 to the primary completion date, 31 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe tape allergy
- Visual impairment such that CGM data cannot be viewed.
- History of an adverse reaction to wearing CGM in the past (e.g., increased anxiety and/or an increase in acute diabetes complications such as DKA/severe hypoglycemia).
- Subject cannot follow instructions due to a medical condition or mental illness.
Other
- Subject is currently pregnant or lactating or plan on becoming pregnant during the course of the study.
Who the study is looking for
- Diagnosis of type 1 or type 2 diabetes for at least 6 months
- Age \>18 years old
- On medication for treatment of diabetes-any oral or injectable agents on a stable dose of medication for at least 3 months.
- If on insulin performing blood glucose monitoring (BGM) at least 3 times per week
- Patients may be current continuous glucose monitor (CGM) users, prior CGM users or naïve to CGM.
- No serious illnesses where life expectancy is \<1 year
- Understand the study requirements and agree to comply with all study visits and procedures, including the use of the study CGM.
- Fluent in English or Spanish
- Must have a smart phone or access to a computer that can connect to LibreView.
- Under the care of a Los Angeles County + University of Southern California provider who can prescribe diabetes medications and make dose adjustments/medication intensification as needed.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Southern California Eastside Center for Diabetes Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.