Telemedicine Monitoring of Nocturnal Incidents of Treatment-Requiring Hypoglycemia in Older Adults With Type 1 Diabetes Miletus - A Feasibility Study

SUMMARY OF STUDY RATIONAL - Reducing hypoglycemia is an important aspect of management of T1D in older adults, many of whom have hypoglycemic unawareness, cognitive impairment, or both. CGM offers the opportunity to reduce hypoglycemia and its related complications such as fractures from falls and hospitalizations and improve QOL including reducing hypoglycemic fear and diabetes distress. Despite these potential benefits, CGM is used by only a small proportion of older adults with T1D (19% in the T1D Exchange registry). Previous studies assessing CGM efficacy have included only a small number of adults ≥ 60 years of age, excluded patients most prone to severe hypoglycemia (SH), focused on improving HbA1c rather than hypoglycemia, and used older generation CGM sensors. These studies are not generalizable to the population of older adults with T1D. The potential benefit of CGM in reducing hypoglycemia in the older adult population has not been well studied. Prior and on-going trials compare CGM to self-monitoring of blood glucose levels, but none look at remote daily monitoring of CGM data. Moreover, in none of the studies is education standardized. The follow-up of patients is done only at routine clinic visits, without any particular oversight of glucose values on an on-going basis. In some cases individual patients may share their data with a family member, but these are generally not trained medical personnel and the Dexcom provided by Medicare has the "share" feature disabled.

INTERVENTION Baseline Visit: Participants will sign informed consent, complete questionnaires, measure HbA1C, start new CGM sensor and be signed in to the Tidepool application for TeleMonitoring.

Visit 1- will occur at Week @ 2 where 14 days of CGM data will be downloaded from participants' device, systems will be checked for functioning status, remote monitoring program will be activated, telemedicine procedure will be discussed with patient; emergency contact numbers will be obtained in case patient cannot be reached.

TeleMonitoring -This will consist of an out going call/email to the patient if one of the following occur has occurred in the past 24 hours: ≥4 hours without CGM signal, ≥2 hours 54 - 70 mg/dl and/or 15 minutes <54 mg/dl. The study coordinator will be alerted each morning though the Tidepool program to patients who fit these criteria. The outgoing call/email will consist of questions to find out why the event happened and then suggestions on how to trouble shoot to avoid issues in the future. If needed the patient will be seen in person for an education/training session. If the patient cannot be reached within 6 hours, the patient's emergency contact will be notified if the PI feels that such out reach is warranted.

Visit 2 - will occur at 14 weeks. Questionnaires will be administered, A1C measured and CGM data and compare to baseline.