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Telemedicine Monitoring of Nocturnal Incidents

NCT04328896 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-04-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

CGM-Tele-monitoring

Baseline Visit-Visit 0 1. Obtain informed consent 2. Administer questionnaires 3. Measure A1C 4. Start study Dexcom CGM device (those already on CGM will change to the study device). 5. The patient will be signed into Tidepool using a research code name and email. Visit 1-2 weeks 1. 14 days worth of data will be downloaded from the patient's CGM device. 2. Systems will be checked to be sure they are functioning 3. Remote monitoring program will be activated. 4. Telemedicine procedure will be discussed with patient; emergency contact numbers will be obtained in case patient cannot be reached Visit 2-14 weeks 1. Administer questionnaires 2. Measure A1C. 3. Collect CGM data and compare to baseline Testing and Assessments: * Continuous glucose monitoring * Tidepool cloud upload * HbA1c * T1D REDEEM diabetes distress questionnaire * Hypoglycemia Fear Survey * Assessment of Severe Hypoglycemia and Diabetic Ketoacidosis

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Principal Investigators

  • Anne Peters, MD · University of Southern California

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-15
Primary Completion
2018-11-30
Completion
2018-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04328896 on ClinicalTrials.gov