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 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.
• 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.