Dexcom Continuous Glucose Monitoring in Long-term Care

NCT04818242 | Completed Results DMC FDA Device

• 1 other identifier: STUDY00001529
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to determine whether the use of Dexcom Continuous Glucose Monitoring with Glucose Telemetry System (CGM-GTS) with hypoglycemia alarm will facilitate diabetes treatment and reduce the risk of hypoglycemia in insulin and non-insulin treated patients with type 2 diabetes (T2D) in long-term care facilities, when compared to standard of care using capillary point of care testing.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Keywords

Continuous glucose monitoring; Glucose telemetry system; Long term care

Outcome Measures

Primary Outcomes (3)

• Number of Participants Experiencing Hypoglycemia (BG<70 mg/dL)

  The number of participants with hypoglycemia detected, where hypoglycemia is defined as blood glucose (BG) of less than 70 mg/dL.

  During hospitalization (up to 60 days of admission)

• Number of Participants Experiencing Clinically Significant Hypoglycemia (BG<54 mg/dL)

  Clinically significant hypoglycemia is defined as blood glucose levels less than 54 mg/dL.

  During hospitalization (up to 60 days of admission)

• Time in Range (TIR) Between 70-180 mg/dL

  Glycemic control is measured by time that blood glucose levels are in the range of 70 to 180 mg/dL.

  During hospitalization (up to 60 days of admission)

Secondary Outcomes (13)

• Number of Events of Nocturnal Hypoglycemia

  During hospitalization (up to 60 days of admission)

• Number of Hypoglycemia Events

  During hospitalization (up to 60 days of admission)

• Time in Hypoglycemia (BG<70 mg/dL)

  During hospitalization (up to 60 days of admission)

• Percent of Time in Hypoglycemia (BG<54 mg/dL)

  During hospitalization (up to 60 days of admission)

• Percent of Time in Hyperglycemia (BG > 180 mg/dL)

  During hospitalization (up to 60 days of admission)

Study Arms (2)

POC testing with Blinded CGM (Standard of Care)

ACTIVE COMPARATOR

Patients in the standard of care study arm will wear a blinded CGM and receive POC testing before meals and bedtime, with providers adjusting oral agents or insulin dose based on POC results.

Diagnostic Test: POC Blood Glucose Test + Blinded CGM

Dexcom CGM with Glucose Telemetry System (CGM-GTS)

EXPERIMENTAL

Patients in the intervention CGM study arm will have a single daily fasting POC testing and will wear a real-time Dexcom G6 with GTS, and providers will adjust oral or insulin therapy based on CGM-GTS profile information.

Device: Dexcom G6 CGM with GTS

Interventions

Dexcom G6 CGM with GTS DEVICE

CGM sensor will be placed after consent. Glucose values obtained from the CGM sensor will be sent to the CGM transmitter by Bluetooth technology and Dexcom Share2 software application to a smart phone that serves as an intermediate-transmitting (routing) device. Glucose values from the smart phone will be transmitted wirelessly to a table computer (I-Pad) using the Dexcom Follow application. Information on the CGM will activate an alarm in case of hypoglycemia or hyperglycemia events. Hypoglycemia alarm will be set to \< 85 mg/dl (for prevention for low blood glucose levels). Nursing staff will be instructed to provide 15 grams of carbohydrates in response to a hypoglycemia alarm.The hyperglycemia alarm will be set at 300 mg/dl. If this occurs, the nursing staff will assess clinical status and perform a POC glucose testing to confirm glucose values. If blood glucose (BG) \> 300 mg/dl, nursing staff will communicate the high glucose value to the primary care team.

Also known as: Dexcom Glucose Telemetry System

Dexcom CGM with Glucose Telemetry System (CGM-GTS)

POC Blood Glucose Test + Blinded CGM DIAGNOSTIC_TEST

Point of Care (POC) testing before meals and bedtime (standard of care). For the control group, participants will also get a CGM sensor (blinded CGM). CGM alarms are turned off, however if the POC is found to be between \<80 mg/dl by POC, 15 grams of carbohydrates will be given as a preventive measurement for hypoglycemia (standard of care).

Also known as: Standard of care capillary glucose test and blinded CGM

POC testing with Blinded CGM (Standard of Care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females admitted to subacute and long-term skilled nursing care facilities.
• Known history of T2D treated with insulin or insulin secretagogues with or without additional oral antidiabetic agents, short- and long-acting glucagon-like peptide-1 receptor agonists (GLP-1 RA).
• Patients with an expected long-term care facility length-of-stay \> 1 week.

You may not qualify if:

• Patients expected to require MRI procedures during admission.
• Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, end-stage renal disease (dialysis), or anasarca (massive peripheral edema).
• Female subjects who are pregnant or breast-feeding at time of enrollment into the study.

Sponsors & Collaborators

• Emory University: lead
• DexCom, Inc.: collaborator

Study Sites (2)

A.G. Rhodes

Atlanta, Georgia, 30329, United States

Location

Emory Wesley Woods Hospital

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Guillermo E. Umpierrez
• Organization: Emory University

geumpie@emory.edu

(404) 778-1663

Study Officials

• Guillermo Umpierrez

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 26, 2021
• Study Start: April 19, 2021
• Primary Completion: October 21, 2022
• Study Completion: October 21, 2022
• Last Updated: November 13, 2023
• Results First Posted: November 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Individual participant data will be available for sharing beginning 6 months after publication of the results from this study and ending 5 years after the results from this study were published.
• Access Criteria: Proposals should be directed to geumpie@emory.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (2)