N/A
N=100
Dexcom Continuous Glucose Monitoring in Long-term Care
Diabetes · Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT04818242 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Number of Participants Experiencing Hypoglycemia (BG<70 mg/dL) — 4; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dexcom G6 CGM with GTS (Device); POC Blood Glucose Test + Blinded CGM (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Hypoglycemia (BG<70 mg/dL) |
4; 9 | — |
| PRIMARY Number of Participants Experiencing Clinically Significant Hypoglycemia (BG<54 mg/dL) |
0; 1 | — |
| PRIMARY Time in Range (TIR) Between 70-180 mg/dL |
48.8; 53.4 | — |
| SECONDARY Number of Events of Nocturnal Hypoglycemia |
0.42; 0.55; 0.28; 0.19 | — |
| SECONDARY Number of Hypoglycemia Events |
4; 13; 0; 1 | — |
| SECONDARY Time in Hypoglycemia (BG<70 mg/dL) |
1.18; 0.83 | — |
| SECONDARY Percent of Time in Hypoglycemia (BG<54 mg/dL) |
0.6; 0.2 | — |
| SECONDARY Percent of Time in Hyperglycemia (BG > 180 mg/dL) |
49.1; 45.8 | — |
| SECONDARY Percent of Time in Hyperglycemia (BG>250 mg/dL) |
17.8; 16.5 | — |
| SECONDARY Number of Events of Prolonged Hypoglycemia |
0.12; 0.04; 0.12; 0.04 | — |
| SECONDARY Number of Hypoglycemia Events During the Day and Night |
1.04; 1.70; 0.58; 0.64 | — |
| SECONDARY Number of Events of Hyperglycemia > 180 mg/dL |
77; 96 | — |
| SECONDARY Number of Events of Hyperglycemia > 240 mg/dL |
54; 75 | — |
| SECONDARY Percentage of POC BG Readings Within Target BG of 70 and 180 mg/dL |
68; 61 | — |
| SECONDARY Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) |
62.17; 64.03 | — |
| SECONDARY Number of Participants With Problems With Sensor Insertion |
0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04818242). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.