Telemedicine Monitoring of Nocturnal Incidents

NCT04328896 | Completed

• 1 other identifier: TELE-MONITOR
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Diabetes Mellitus, Type 1; Hypoglycemia

Keywords

Remote Daily Monitoring; Continuous Glucose Monitoring; Tele-Medicine

Outcome Measures

Primary Outcomes (1)

• CGM-Tele-monitoring effects on hypoglycemia

  Number of patients with lower incidents of hypoglycemia as assessed by CGM data and self report from baseline to 14 weeks.

  14 weeks

Secondary Outcomes (6)

• CGM-Tele-monitoring effects on CGM adherence

  14 weeks

• CGM-Tele-monitoring effects on hypoglycemic fear

  14 weeks

• CGM-Tele-monitoring effects on diabetes distress

  14 weeks

• CGM - Tele-monitoring effects on diabetes knowledge

  14 weeks

• CGM - Tele-monitoring effects on diabetic ketoacidosis

  14 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Tele-CGM-monitoring: Subjects are remotely monitored daily through a continuous glucose monitoring (CGM) system (Dexcom G5/6) that communicates via smart phone to a Tidepool designed dashboard. Alerts set for: ≥4 hours without CGM signal, ≥2 hours 54-70 mg/dl, and 15 minutes \<54 mg/dl. Tidepool dashboard automatically emails daily alerts to the Certified Diabetes Educator (CDE). If alerts occurred, the CDE performed telemedicine outreach based on type of alert.

Other: CGM-Tele-monitoring

Interventions

CGM-Tele-monitoring OTHER

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

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

USC Westside Center for Diabetes

Los Angeles, California, 90211, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Anne Peters, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Medicine

Model Details: This study is a 14 week, single center, pilot study of 10 subjects 65-75 yrs old with type 1 diabetes.

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: April 1, 2020
• Study Start: June 15, 2018
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: April 1, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)