Dexcom CGM in Long-term Care

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

Diabetes is prevalent in adults admitted to subacute rehab (SAR) and long-term care (LTC) skilled nursing care facilities. Management of diabetes in these facilities is challenging due to number of older adults with higher prevalence of other diseases, functional disability, and altered nutritional intake, which increase the risk of hypoglycemia (low blood sugars). The investigators propose to conduct this randomized controlled trial to determine whether the use of Dexcom CGM with Glucose Telemetry System (CGM-GTS) with hypoglycemia alarm compared to standard of care using capillary POC testing, will facilitate diabetes treatment and reduce the risk of hypoglycemia in patients with T2D in LTC facilities. Participants in the standard of care group will also wear a CGM (blinded one). The results of this study have great potential to impact and facilitate care and to change current clinical guidelines in the management of older adults with diabetes in SAR and LTC facilities.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Intervention / Treatment: Diagnostic test: POC BG + Blinded CGM; Device: Dexcom G6 CGM with CTS

Detailed Description

Diabetes is prevalent in adults admitted to subacute rehab (SAR) and long-term care (LTC) skilled nursing care facilities.

Management of diabetes in these facilities is challenging due to number of older adults with higher prevalence of other diseases, functional disability, and altered nutritional intake, which increase the risk of hypoglycemia (low blood sugars).

Many Clinical guidelines recommend the use of insulin, as the preferred therapy for glycemic (sugar) control for most patients with type 2 diabetes (T2D). The use of insulin is effective in improving glycemic control, but associated with high rates of hypoglycemia in LTC residents with T2D. This high rate of hypoglycemia is concerning, because hypoglycemia has been associated with many complications and mortality.

The bedside capillary point of care (POC) glucose monitoring is the standard of care to assess glycemic control in the hospital and in LTC facilities. POC testing is usually performed before meals and at bedtime. Continuous Glucose Monitoring (CGM) measures glucose every 5-15 minutes, thus provides a more complete glycemic profile during 24-hours when compared to POC testing.

The investigators propose to conduct a randomized controlled trial to determine whether the use of Dexcom CGM with Glucose Telemetry System (CGM-GTS) with hypoglycemia alarm compared to standard of care using capillary POC testing, will facilitate diabetes treatment and reduce the risk of hypoglycemia in patients with T2D in LTC facilities. Participants in the standard of care group will also wear a CGM (blinded one).

Potential Participants will be identified from electronic medical records and enrolled during admission to subacute rehabilitation (SAR)and long-term care (LTC) skilled nursing care facilities and will be followed up for up to sixty (60) days or discharge (whichever comes sooner). Subjects will be compensated for their participation.

The results of this study have great potential to impact and facilitate care and to change current clinical guidelines in the management of older adults with diabetes in SAR and LTC facilities.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Saumeth Cardona, MD; Phone Number: 404-251-8957; Email: scardon@emory.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Recruiting
      • A.G. Rhodes
      • Contact: Emmelin Moreno; Phone Number: 404-686-7397; Email: emmelin.marie.moreno@emory.edu
    • Atlanta, Georgia, United States, 30329
      • Recruiting
      • Emory Wesley Woods Hospital
      • Contact: Emmelin Moreno; Phone Number: 404-686-7397; Email: emmelin.marie.moreno@emory.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and females admitted to subacute and long-term skilled nursing care facilities.
• Known history of T2D treated with insulin (glargine, detemir, degludec, NPH, premixed insulin) or sliding scale regular insulin) or insulin secretagogues (sulfonylureas, repaglinide, nateglinide) with or without additional oral antidiabetic agents (alpha-glucosidase inhibitors, thiazolidinedione, SGLT2- inhibitors, DPP4-inhibitors), short- and long-acting GLP1-RA (exenatide, liraglutide, dulaglutide, semaglutide).
• Patients with an expected LTC 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: POC testing with Blinded CGM Group (Standard of Care Group); Patients in the standard of care group 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 BG + Blinded CGM; 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).; Other Names: Standard of care capillary glucose test and blinded CGM
Experimental: Dexcom CGM with Glucose Telemetry System Group (CGM-GTS Group); Patients in the intervention CGM group 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 CTS; 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 BG > 300 mg/dl, nursing staff will communicate the high glucose value to the primary care team.; Other Names: Dexcom Glucose Telemetry System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of events of Hypoglycemia <70 mg/dl	Number of events of Hypoglycemia <70 mg/dl between POC testing group and CGM-GTS group (safety outcome)	During hospitalization (up to 60 days of admission)
Number of events of clinically significant hypoglycemia <54 mg/dl	Number of events of clinically significant hypoglycemia <54 mg/dl between POC testing group and CGM-GTS group (safety outcome)	During hospitalization (up to 60 days of admission)
Time in range (TIR) between 80-180 mg/dl	Glycemic control will be measured by time in range (TIR) between 80-180 mg/dl during admission (efficacy outcome)	During hospitalization (up to 60 days of admission)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of events of nocturnal hypoglycemia < 70 mg/dL and <54 mg/dL between POC testing group and CGM-GTS group	Number of events of nocturnal hypoglycemic events for BGs < 70 mg/dl and <54 mg/dL will be recorded between 22:00 and 06:00	During hospitalization (up to 60 days of admission)
Number of hypoglycemia events	Number of events of hypoglycemia <70 mg/dl and <54 mg/dl between POC testing group and CGM-GTS group	During hospitalization (up to 60 days of admission)
Time in hypoglycemia (<70 mg/dl) in minutes	Time in hypoglycemia (<70 mg/dl) in minutes between POC testing group and CGM-GTS group	During hospitalization (up to 60 days of admission)
Time in hyperglycemia (>240 mg/dl) in minutes	Time in hyperglycemia (>240 mg/dl) in minutes between POC testing group and CGM-GTS group	During hospitalization (up to 60 days of admission)
Number of prolonged hypoglycemia > 1 and 2 hours by CGM	Number of participants with prolonged hypoglycemia > 1 and 2 hours by CGM between POC testing group and CGM-GTS group	During hospitalization (up to 60 days of admission)
Number of hypoglycemia events during the day and night	Number of hypoglycemia events during the day and night between POC testing group and CGM-GTS group	During hospitalization (up to 60 days of admission)
Time in hypoglycemia (minutes)	Time in hypoglycemia (minutes) during the day and night between POC testing group and CGM-GTS group	During hospitalization (up to 60 days of admission)
Number of events of hyperglycemia > 240 mg/dl	Number of events of hyperglycemia > 240 mg/dl during the day and night between POC testing group and CGM-GTS group	During hospitalization (up to 60 days of admission)
Time in hyperglycemia > 240 mg/dl (minutes)	Time in hyperglycemia > 240 mg/dl (minutes) during the day and night	During hospitalization (up to 60 days of admission)
Percentage of BG readings within target BG of 70 and 180 mg/dl	Percentage of BG readings within target BG of 70 and 180 mg/dl of all BG readings	During hospitalization (up to 60 days of admission)
Glycemic variability calculated by Mean amplitude of glycemic excursions (MAGE)	Mean amplitude of glycemic excursions (MAGE), together with mean and SD, is the parameter for assessing glycemic variability and is calculated based on the arithmetic mean of differences between consecutive peaks and nadirs of differences greater than one SD of mean glycemia. It is designated to assess major glucose swings and exclude minor ones.	During hospitalization (up to 60 days of admission)
Number of sensor removed	Number of sensor removed for procedures/imaging, sensors failures, sensors dislodgments	During hospitalization (up to 60 days of admission)

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: DexCom, Inc.
• Investigators: Principal Investigator: Guillermo Umpierrez, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 6, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Continuous glucose monitoring; Long term care; Glucose telemetry system
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: STUDY00001529

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices) will be shared to Researchers who provide a methodologically sound proposal, to achieve the aims in the approved proposal.
• IPD Sharing Time Frame: Start 6 months after publication End 5 years after publication
• IPD Sharing Access Criteria: Proposals should be directed to geumpie@emory.edu. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No