Telemedicine Continuous Remote Monitoring of Adults With Uncontrolled Diabetes Mellitus

SUMMARY OF STUDY RATIONAL - Our project focuses on two populations; those with type 1 diabetes (T1D) and those with poorly controlled type 2 diabetes (T2D). Telemedicine Monitoring of Adults with Uncontrolled Diabetes Mellitus (Tele-MONITOR DM) is designed to reduce health care disparities in under resourced populations by enhancing existing telehealth visits for individuals with poorly controlled diabetes through continuous glucose monitoring (CGM) with data automatically transmitted to a clinic dashboard to allow for outreach to patients as needed in between routinely scheduled visits and feedback to primary care providers for medication management.

Few people with diabetes reach their treatment targets. This is particularly true for the under resourced who lack access to medical care who often have very high glucose levels, as well as have a risk for hypoglycemia. For our patients, part of the difficulty in accessing care is the disruption it creates in their schedule to take the time to come in for an office visit. The use of telemedicine due to the COVID pandemic has expanded our ability to reach patients in a convenient manner, based on the patient's preferences rather than a fixed clinic schedule. Use of technology has increased along with this, particularly because Medicare rules for covering technology have expanded. This allows for close monitoring and frequent medication dose adjustment to treat both hyper- and hypo-glycemia. These lessons learned during COVID create a new opportunity to expand the use of technology to underserved areas where uptake has been lagging but where the need is greatest.

Our system of monitoring, which the investigators originally called Tele-CGM will send alerts to our clinic that will allow for outreach to patients who need assistance, rather than waiting for them to contact the clinic. By looking both at the daily alerts as well as weekly data updates on each patient, the investigators should help keep patients safer, start and uptitrate guideline-recommended medications more effectively and work to encourage adherence to lifestyle and medications. Originally, the investigators had hoped to develop our Tele-CGM system to include data from all CGM systems. Unfortunately this is not currently possible. Therefore the investigators plan to work the Freestyle Libre 2. The data will be monitored through the existing LibreView system, with enhanced functionality for population management. The CGM system selected for each patient will be individualized based on the patient's preferences, clinical need for the device and insurance coverage (if available). For those without a CGM, they will be provided with a Freestyle Libre device free of charge.

If our findings prove the utility of our system, it will validate the role of treatment intensification for diabetes management in primary care, using asynchronous data collection from CGM devices by diabetes educators supervised by an endocrinologist. It will also assess the utility of a device-dashboard that will provide near real-time alerts to clinic staff so that they can respond to unusually high and low blood glucose values as well as discontinuation of sensor use.

INTERVENTION Baseline Visit-Visit 1 1. Obtain informed consent 2. Obtain clinical data on patient including diabetes and medical history 3. Administer questionnaires 4. Measure point of care HbA1C 5. Start blinded CGM device (even if using their own CGM) Baseline Blinded CGM wear - Visit 2