Telemedicine Continuous Remote Monitoring of Adults With Uncontrolled Diabetes Mellitus

NCT05161793 | Completed FDA Device

• 1 other identifier: TELE-MONITOR DM
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Keywords

Continuous Glucose Monitoring; Remote Monitoring

Outcome Measures

Primary Outcomes (1)

• CGM - Tele-monitoring effects on HbA1c

  Number of patients with decreased HbA1c as measured by point of care HbA1c level from baseline to 12 months.

  12-months

Secondary Outcomes (7)

• CGM-Tele-monitoring effects on CGM adherence

  12-months

• CGM-Tele-monitoring effects on glucose time in range (TIR)

  12-months

• CGM-Tele-monitoring effects on depression

  12 months

• CGM-Tele-monitoring effects on glucose monitoring satisfaction

  12 months

• CGM-Tele-monitoring effects on diabetes treatment satisfaction

  12 months

Study Arms (2)

CGM-Tele-monitoring Type 1

Tele-CGM-monitoring: Subjects are remotely monitored daily through a continuous glucose monitoring (CGM) system (Libre 2) that communicates via smart phone to a Libreview designed dashboard. Alerts set for: ≥4 hours without CGM signal, ≥2 hours 54-70 mg/dl, and 15 minutes \<54 mg/dl. Libreview dashboard automatically emails daily alerts to the Certified Diabetes Care and Education Specialist (CDCES). If alerts occurred, the CDCES performed telemedicine outreach based on type of alert.

Device: Tele-Monitor DM

CGM-Tele-monitoring Type 2

Tele-CGM-monitoring: Subjects are remotely monitored daily through a continuous glucose monitoring (CGM) system (Libre 2) that communicates via smart phone to a Libreview designed dashboard. Alerts set for: ≥4 hours without CGM signal, ≥2 hours 54-70 mg/dl, and 15 minutes \<54 mg/dl. Libreview dashboard automatically emails daily alerts to the Certified Diabetes Care and Education Specialist (CDCES). If alerts occurred, the CDCES performed telemedicine outreach based on type of alert.

Device: Tele-Monitor DM

Interventions

Tele-Monitor DM DEVICE

Remote monitoring of CGM data to identify, contact, and provide diabetes management for patients who are having episodes of hypoglycemia, hyperglycemia and/or difficulty using their CGM device.

CGM-Tele-monitoring Type 1; CGM-Tele-monitoring Type 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

200 English or Spanish speaking subjects (125 adults with type 2 and 75 with type 1 diabetes)

You may qualify if:

• Diagnosis of type 1 or type 2 diabetes for at least 6 months
• HbA1C \>8% or any episode of level three hypoglycemia or diabetic ketoacidosis (DKA) in the past 6 months or at least once weekly episodes of level 1 or 2 hypoglycemia
• 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.

You may not qualify if:

• Severe tape allergy
• Visual impairment such that CGM data cannot be viewed.
• On dialysis
• 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 is currently pregnant or lactating or plan on becoming pregnant during the course of the study.
• Subject cannot follow instructions due to a medical condition or mental illness.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California Eastside Center for Diabetes

Los Angeles, California, 90022, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 17, 2021
• Study Start: May 1, 2022
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: July 3, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)