Telemedicine Monitoring of Nocturnal Incidents

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 1, Hypoglycemia

In brief

Reducing hypoglycemia is an important aspect of management of type 1 diabetes (T1D) in older adults, many of whom have hypoglycemic unawareness, cognitive impairment, or both. Continuous Glucose Monitoring (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. 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 or provision of telemedicine based on clinic notification of hypoglycemic events. This study is a 14 week, single center, pilot study of 10 subjects 65-75 yrs old with type 1 diabetes. The primary aim is to determine the effect of continuous remote CGM reporting coupled with a telemedicine intervention (Tele-CGM program) on rates of hypoglycemia in adults with T1D \>65 years old. Study staff will review Tidepool uploads and 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. Tele-monitoring call will include questions to find out why the event happened and then suggestions on how to trouble shoot to avoid issues in the future. As this is a feasibility study, statistical considerations were not used.

Key facts

Study ID

NCT04328896

Run by

University of Southern California

People needed

10

Starts

2018-06-15

Expected to finish

2018-11-30

Last updated by the study team

2020-04-01

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of type 1 diabetes
• Age >65 years old
• Insulin regimen involves either use of an insulin pump or multiple daily injections of insulin.
• 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

You may not qualify if…

• No serious illnesses where life expectancy is <1 year

Where it is running

• USC Westside Center for Diabetes — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.