At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Controlled Trial To Assess the Benefits of Dexcom Continuous Glucose Monitoring With Glucose Telemetry System for the Management of Diabetes in Long-term Care Setting: The CGM-GTS in Long-term Care
In Brief
A clinical study evaluating Dexcom G6 CGM with GTS and POC Blood Glucose Test + Blinded CGM for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 100 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.
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).