Dexcom Continuous Glucose Monitoring in Long-term Care
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About
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.
Full 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.
Enrollment
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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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
100 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Saumeth Cardona, MD; Guillermo Umpierrez, MD
Data sourced from clinicaltrials.gov
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