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Clinical trialNCT04328896CompletedInterventional

Telemedicine Monitoring of Nocturnal Incidents

SponsorUniversity of Southern CaliforniaEnrollment10Diabetes Mellitus, Type 1Hypoglycemia
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

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Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Usc Westside Center for Diabetes

    Los Angeles, California, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
15 Jun 2018
Primary completion
30 Nov 2018
Completion
30 Nov 2018
Last update posted
1 Apr 2020
Registered enrollment
10
Registry id
NCT04328896

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.