Clinical trial NCT04818242: Dexcom Continuous Glucose Monitoring 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Diabetes Mellitus, Type 2
Keywords: Continuous glucose monitoring
Glucose telemetry system
Long term care
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2021-03-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: The prevalence of diabetes increases with age, and it is estimated that more than 20% of older adults aged 65-75 years and 40% of adults over 80 years of age have diabetes. The prevalence of diabetes in older adults is expected to increase due to longer life expectancy and improvements in care. The estimated prevalence of diabetes in subacute and long-term skilled nursing care facilities is reported to be around 20% to 34% and, in parallel to the increasing geriatric population, the number of long-term care (LTC) admissions is expected to rise.

The goals of diabetes care in older adults and patients in subacute and long-term skilled nursing care facilities include control of hyperglycemia and its symptoms, prevention and treatment of diabetic complications, and maintenance or improvement of general health status. Studies in hospitalized patients with diabetes have shown that improvement in glucose control can reduce complications and are cost savings, however, no prospective studies have determined the impact of improving glucose control on clinical outcome in subacute and long-term skilled nursing care facilities. The management of diabetes in LTC residents is similar to that recommended for ambulatory patients with diabetes, however, several factors complicate the management of hyperglycemia in this population. LTC residents tend to be older and to have higher rates of comorbidities associated with aging such as functional disability, hypertension, coronary artery disease, cerebrovascular events, depression, cognitive impairment, urinary incontinence, and higher risk of falls. In addition, they often experience changes in nutritional intake, which increase the risk of hypoglycemia.

Current guidelines and position statements on diabetes management in older adults are based on consensus opinions or from extrapolations from studies involving middle-aged patients with diabetes. The American Diabetes Association guidelines recommend that older adults who are functional, cognitively intact, and have longer life expectancy should receive diabetes care with goals similar to those developed for younger adults. In these subjects, a HbA1c level \<7.5%, a fasting glucose between 90-130 mg/dl, and a random glucose \<180 mg/dl is recommended. Less intensive goals are recommended for patients with advanced complications, life-limiting comorbid illness, or cognitive impairment. Other organizations including the American Geriatric Society, European Diabetes Working Party for Older People guidelines, International Association of Gerontology and Geriatrics, the European Diabetes Working Party for Older People recommend a target HbA1c of \<7.5% for patients without major comorbidities while a higher target of 7.6-8.5% is proposed for frail patients with high risk of hypoglycemia. These guidelines highlight the importance of improved glucose control and avoidance of side effects and hypoglycemia, as they are associated with increased risk of complications and mortality in patients with diabetes.

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 interstitial glucose every 5-15 minutes, thus providing a more complete glycemic profile during 24-hours than POC testing. This study is a randomized clinical trial to assess the impact of glucose control and hypoglycemia reduction with the use of real time CGM with an alarm system to prevent hypoglycemia and facilitate the care of insulin and non-insulin treated patients with T2D in subacute and long-term skilled nursing care facilities. 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 subacute and LTC facilities.

Residents with T2D in subacute and long-term skilled nursing care facilities treated with insulin and/or insulin-secretagogues will be randomized to a standard of care group with POC testing or to real time Dexcom CGM with GTS until discharge or for up to 60 days of admission (whichever comes sooner). Participants 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. Participants 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.

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.

Primary outcomes:
measure: Number of Participants Experiencing Hypoglycemia (BG<70 mg/dL)
timeFrame: During hospitalization (up to 60 days of admission)
measure: Number of Participants Experiencing Clinically Significant Hypoglycemia (BG<54 mg/dL)
timeFrame: During hospitalization (up to 60 days of admission)
measure: Time in Range (TIR) Between 70-180 mg/dL
timeFrame: During hospitalization (up to 60 days of admission)
Secondary outcomes:
measure: Number of Events of Nocturnal Hypoglycemia
timeFrame: During hospitalization (up to 60 days of admission)
measure: Number of Hypoglycemia Events
timeFrame: During hospitalization (up to 60 days of admission)
measure: Time in Hypoglycemia (BG<70 mg/dL)
timeFrame: During hospitalization (up to 60 days of admission)
measure: Percent of Time in Hypoglycemia (BG<54 mg/dL)
timeFrame: During hospitalization (up to 60 days of admission)
measure: Percent of Time in Hyperglycemia (BG > 180 mg/dL)
timeFrame: During hospitalization (up to 60 days of admission)
measure: Percent of Time in Hyperglycemia (BG>250 mg/dL)
timeFrame: During hospitalization (up to 60 days of admission)
measure: Number of Events of Prolonged Hypoglycemia
timeFrame: During hospitalization (up to 60 days of admission)
measure: Number of Hypoglycemia Events During the Day and Night
timeFrame: During hospitalization (up to 60 days of admission)
measure: Number of Events of Hyperglycemia > 180 mg/dL
timeFrame: During hospitalization (up to 60 days of admission)
measure: Number of Events of Hyperglycemia > 240 mg/dL
timeFrame: During hospitalization (up to 60 days of admission)
measure: Percentage of POC BG Readings Within Target BG of 70 and 180 mg/dL
timeFrame: During hospitalization (up to 60 days of admission)
measure: Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE)
timeFrame: During hospitalization (up to 60 days of admission)
measure: Number of Participants With Problems With Sensor Insertion
timeFrame: During hospitalization (up to 60 days of admission)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: A.G. Rhodes
state: Georgia
city: Atlanta
country: United States
facility: Emory Wesley Woods Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Guillermo Umpierrez
role: PRINCIPAL_INVESTIGATOR
References: