NCT04818242

Dexcom Continuous Glucose Monitoring in Long-term Care

Completed NA Results posted Last updated 13 November 2023

What this trial tests

NA trial testing Dexcom G6 CGM with GTS in Diabetes in 100 participants. Completed in 21 October 2022.

Timeline

19 April 2021

Primary endpoint
21 October 2022

21 October 2022

Quick facts

Lead sponsor	Emory University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	100
Start date	19 April 2021
Primary completion	21 October 2022
Estimated completion	21 October 2022
Sites	2 locations across United States

Drugs / interventions tested

• Dexcom G6 CGM with GTS
• POC Blood Glucose Test + Blinded CGM

Conditions studied

• Diabetes — all drugs for Diabetes →
• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Emory University

Who can join

18 and older, any sex, with Diabetes or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Experiencing Hypoglycemia (BG<70 mg/dL) Primary · During hospitalization (up to 60 days of admission)

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

Group	Value	95% CI
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)	4
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)	9

Number of Participants Experiencing Clinically Significant Hypoglycemia (BG<54 mg/dL) Primary · During hospitalization (up to 60 days of admission)

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

Group	Value	95% CI
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)	0
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)	1

Time in Range (TIR) Between 70-180 mg/dL Primary · During hospitalization (up to 60 days of admission)

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

Group	Value	95% CI
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)	48.8	± 28.0
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)	53.4	± 30.2

Number of Events of Nocturnal Hypoglycemia Secondary · During hospitalization (up to 60 days of admission)

The average number of events of nocturnal hypoglycemic events across all participants for BG \< 70 mg/dL and \<54 mg/dL occurring between 22:00 and 06:00.

Blood glucose <70 mg/dL

Group	Value	95% CI
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)	0.42	± 1.23
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)	0.55	± 1.54

Blood glucose <54 mg/dL

Group	Value	95% CI
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)	0.28	± 0.88
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)	0.19	± 0.77

Number of Hypoglycemia Events Secondary · During hospitalization (up to 60 days of admission)

The total number of events of hypoglycemia events (BG \<70 mg/dL and \<54 mg/dL) across participants.

Blood glucose <70 mg/dL

Group	Value	95% CI
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)	4
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)	13

Blood glucose <54 mg/dL

Group	Value	95% CI
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)	0
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)	1

Time in Hypoglycemia (BG<70 mg/dL) Secondary · During hospitalization (up to 60 days of admission)

The percent of time in hypoglycemia, defined as blood glucose level \<70 mg/dL, is assessed.

Group	Value	95% CI
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)	1.18	± 3.5
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)	0.83	± 2.6

Percent of Time in Hypoglycemia (BG<54 mg/dL) Secondary · During hospitalization (up to 60 days of admission)

The percentage of time in hypoglycemia with blood glucose levels less than 54 mg/dL.

Group	Value	95% CI
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)	0.6	± 2.2
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)	0.2	± 0.8

Percent of Time in Hyperglycemia (BG > 180 mg/dL) Secondary · During hospitalization (up to 60 days of admission)

The percentage of time in hyperglycemia with blood glucose levels greater than 180 mg/dL.

Group	Value	95% CI
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)	49.1	± 28.1
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)	45.8	± 30.7

Percent of Time in Hyperglycemia (BG>250 mg/dL) Secondary · During hospitalization (up to 60 days of admission)

The percentage of time in hyperglycemia with blood glucose levels \>250 mg/dL.

Group	Value	95% CI
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)	17.8	± 22.8
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)	16.5	± 19.3

Number of Events of Prolonged Hypoglycemia Secondary · During hospitalization (up to 60 days of admission)

The number of events of prolonged hypoglycemia, defined as \> 1 and 2 hours, as determined by CGM.

Blood glucose <70 mg/dL

Group	Value	95% CI
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)	0.12	± 0.52
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)	0.04	± 0.29

Blood glucose <54 mg/dL

Group	Value	95% CI
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)	0.12	± 0.52
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)	0.04	± 0.29

Number of Hypoglycemia Events During the Day and Night Secondary · During hospitalization (up to 60 days of admission)

The number of hypoglycemia events during the day and night in the POC testing group and the CGM-GTS group.

Blood glucose <70 mg/dL

Group	Value	95% CI
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)	1.04	± 2.72
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)	1.70	± 3.21

Blood glucose <54 mg/dL

Group	Value	95% CI
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)	0.58	± 2.00
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)	0.64	± 1.89

Number of Events of Hyperglycemia > 180 mg/dL Secondary · During hospitalization (up to 60 days of admission)

Number of events of hyperglycemia \> 180 mg/dL during the day and night between POC testing group and CGM-GTS group

Group	Value	95% CI
Point-of-care (POC) Testing With Blinded CGM (Standard of Care Study Arm)	77
Dexcom Continuous Glucose Monitoring (CGM) With Glucose Telemetry System (CGM-GTS)	96

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Models for delivery and co-ordination of primary or secondary health care (or both) to older adults living in aged care facilities.
   Putrik P, Grobler L, Lalor A, Ramsay H, et al · · 2024 · cited 4× · PMID 38426600 · DOI 10.1002/14651858.cd013880.pub2
2. Applications and prospects of biomaterials in diabetes management.
   Guan W, Zhang L. · · 2025 · PMID 40124248 · DOI 10.3389/fbioe.2025.1547343