Telemedicine Continuous Remote Monitoring of Adults With Uncontrolled Diabetes Mellitus (NCT05161793) | Clinical Trial Compass
CompletedNot Applicable
Telemedicine Continuous Remote Monitoring of Adults With Uncontrolled Diabetes Mellitus
United States200 participantsStarted 2022-05-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
. 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.