Dexcom CGM in Long-term Care
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dexcom G6 CGM with CTS
POC BG + Blinded CGM
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes focused on measuring Continuous glucose monitoring, Glucose telemetry system, Long term care
Eligibility Criteria
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.
Sites / Locations
- A.G. RhodesRecruiting
- Emory Wesley Woods HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
POC testing with Blinded CGM Group (Standard of Care Group)
Dexcom CGM with Glucose Telemetry System Group (CGM-GTS Group)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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)
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)
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)
Secondary Outcome Measures
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
Number of hypoglycemia events
Number of events of hypoglycemia <70 mg/dl and <54 mg/dl between POC testing group and CGM-GTS group
Time in hypoglycemia (<70 mg/dl) in minutes
Time in hypoglycemia (<70 mg/dl) in minutes between POC testing group and CGM-GTS group
Time in hyperglycemia (>240 mg/dl) in minutes
Time in hyperglycemia (>240 mg/dl) in minutes between POC testing group and CGM-GTS group
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
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
Time in hypoglycemia (minutes)
Time in hypoglycemia (minutes) during the day and night between POC testing group and CGM-GTS group
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
Time in hyperglycemia > 240 mg/dl (minutes)
Time in hyperglycemia > 240 mg/dl (minutes) during the day and night
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
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.
Number of sensor removed
Number of sensor removed for procedures/imaging, sensors failures, sensors dislodgments
Full Information
NCT ID
NCT04818242
First Posted
March 24, 2021
Last Updated
May 6, 2021
Sponsor
Emory University
Collaborators
DexCom, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04818242
Brief Title
Dexcom CGM in Long-term Care
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
DexCom, Inc.
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2
Keywords
Continuous glucose monitoring, Glucose telemetry system, Long term care
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
POC testing with Blinded CGM Group (Standard of Care Group)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Dexcom CGM with Glucose Telemetry System Group (CGM-GTS Group)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Dexcom G6 CGM with CTS
Other Intervention Name(s)
Dexcom Glucose Telemetry System
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
POC BG + Blinded CGM
Other Intervention Name(s)
Standard of care capillary glucose test and blinded CGM
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of events of Hypoglycemia <70 mg/dl
Description
Number of events of Hypoglycemia <70 mg/dl between POC testing group and CGM-GTS group (safety outcome)
Time Frame
During hospitalization (up to 60 days of admission)
Title
Number of events of clinically significant hypoglycemia <54 mg/dl
Description
Number of events of clinically significant hypoglycemia <54 mg/dl between POC testing group and CGM-GTS group (safety outcome)
Time Frame
During hospitalization (up to 60 days of admission)
Title
Time in range (TIR) between 80-180 mg/dl
Description
Glycemic control will be measured by time in range (TIR) between 80-180 mg/dl during admission (efficacy outcome)
Time Frame
During hospitalization (up to 60 days of admission)
Secondary Outcome Measure Information:
Title
Number of events of nocturnal hypoglycemia < 70 mg/dL and <54 mg/dL between POC testing group and CGM-GTS group
Description
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
Time Frame
During hospitalization (up to 60 days of admission)
Title
Number of hypoglycemia events
Description
Number of events of hypoglycemia <70 mg/dl and <54 mg/dl between POC testing group and CGM-GTS group
Time Frame
During hospitalization (up to 60 days of admission)
Title
Time in hypoglycemia (<70 mg/dl) in minutes
Description
Time in hypoglycemia (<70 mg/dl) in minutes between POC testing group and CGM-GTS group
Time Frame
During hospitalization (up to 60 days of admission)
Title
Time in hyperglycemia (>240 mg/dl) in minutes
Description
Time in hyperglycemia (>240 mg/dl) in minutes between POC testing group and CGM-GTS group
Time Frame
During hospitalization (up to 60 days of admission)
Title
Number of prolonged hypoglycemia > 1 and 2 hours by CGM
Description
Number of participants with prolonged hypoglycemia > 1 and 2 hours by CGM between POC testing group and CGM-GTS group
Time Frame
During hospitalization (up to 60 days of admission)
Title
Number of hypoglycemia events during the day and night
Description
Number of hypoglycemia events during the day and night between POC testing group and CGM-GTS group
Time Frame
During hospitalization (up to 60 days of admission)
Title
Time in hypoglycemia (minutes)
Description
Time in hypoglycemia (minutes) during the day and night between POC testing group and CGM-GTS group
Time Frame
During hospitalization (up to 60 days of admission)
Title
Number of events of hyperglycemia > 240 mg/dl
Description
Number of events of hyperglycemia > 240 mg/dl during the day and night between POC testing group and CGM-GTS group
Time Frame
During hospitalization (up to 60 days of admission)
Title
Time in hyperglycemia > 240 mg/dl (minutes)
Description
Time in hyperglycemia > 240 mg/dl (minutes) during the day and night
Time Frame
During hospitalization (up to 60 days of admission)
Title
Percentage of BG readings within target BG of 70 and 180 mg/dl
Description
Percentage of BG readings within target BG of 70 and 180 mg/dl of all BG readings
Time Frame
During hospitalization (up to 60 days of admission)
Title
Glycemic variability calculated by Mean amplitude of glycemic excursions (MAGE)
Description
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.
Time Frame
During hospitalization (up to 60 days of admission)
Title
Number of sensor removed
Description
Number of sensor removed for procedures/imaging, sensors failures, sensors dislodgments
Time Frame
During hospitalization (up to 60 days of admission)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillermo Umpierrez, MD
Phone
404-778-1665
Email
geumpie@emory.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Saumeth Cardona, MD
Phone
404-251-8957
Email
scardon@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo Umpierrez
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
A.G. Rhodes
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmelin Moreno
Phone
404-686-7397
Email
emmelin.marie.moreno@emory.edu
Facility Name
Emory Wesley Woods Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmelin Moreno
Phone
404-686-7397
Email
emmelin.marie.moreno@emory.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Dexcom CGM in Long-term Care
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