A Study Comparing Dexcom Continuous Glucose Monitoring to Point of Care Glucose Testing for the Management of Hospital and Post-Discharge Subjects With Type 1 Diabetes

Официальное название

A Randomized Controlled Trial Comparing Dexcom Continuous Glucose Monitoring to Point of Care Glucose Testing for the Management of Hospital and Post-Discharge Subjects With Type 1 Diabetes

Обзор

This study aims to compare inpatient glycemic control by measuring the percentage of time in the range of 70-180 mg/dl and the frequency of hypoglycemia between Dexcom G7 Continuous Glucose Monitoring (CGM) and Point of Care (POC) Blood Glucose Testing in poorly controlled subjects with Type 1 Diabetes Mellitus. The main question it aims to answer is: -Whether there is a difference between POC testing (standard of care) and Real-time CGM in glycemic control and hypoglycemic events during hospitalization:

Подробное описание

The CDC reports that 1.6 million U.S. adults (5.7%) have type 1 diabetes (T1D), with hospitalization rates three times higher than the general population, primarily due to diabetes-related complications such as ketoacidosis and cardiovascular disease. A study at Emory University found that hospitalized T1D patients are younger, experience longer stays and more admissions, and face worse glycemic control and higher rates of hypoglycemia compared to type 2 diabetes (T2D) patients.

Point-of-care (POC) capillary glucose testing is the standard for monitoring hospitalized diabetes patients, but continuous glucose monitoring (CGM) offers more detailed glycemic profiles. Research, including trials using Dexcom CGM systems, has demonstrated CGM's superior ability to detect hypo- and hyperglycemia, reduce hypoglycemic events, and improve insulin therapy adjustments in T2D patients. However, no randomized controlled studies have evaluated the best glucose monitoring system for hospitalized T1D patients.

The proposed study aims to compare POC testing with Dexcom G7 CGM for guiding insulin therapy in hospitalized T1D patients. Researchers hypothesize that CGM will better prevent hypoglycemia and improve glycemic management during hospital stays, addressing a critical gap in evidence regarding glucose control's impact on T1D hospital outcomes.

Вмешательства

• Устройство Dexcom G7 rtCGM
  The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 CGM System or G7) is a glucose monitoring system that continuously measures glucose in the interstitial fluid. It aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments
• Диагностический тест Capillary Blood glucose Testing (POC)
  POC glucose meters measure whole blood and convert the results to plasma glucose concentrations, which is the standardized form used in clinical practice.

Первичные конечные точки

• Glycemic control [Срок оценки: Through study completion (Day 10 or the length of admission)]
• Clinically significant hypoglycemia <54 mg/dl [Срок оценки: Through study completion (Day 10 or the length of admission)]

Вторичные конечные точки (10)

• Time above range [Срок оценки: Through study completion (Day 10 or the length of admission)]
• Time below range [Срок оценки: Through study completion (Day 10 or the length of admission)]
• Glycemic Variability [% Coefficient of Variation (%CV) [Срок оценки: Through study completion (Day 10 or the length of admission)]
• Hypoglycemic events [Срок оценки: Through study completion (Day 10 or the length of admission)]
• Hyperglycemic events [Срок оценки: Through study completion (Day 10 or the length of admission)]
• Nocturnal hypoglycemia [Срок оценки: Through study completion (Day 10 or the length of admission)]
• Prolonged hypoglycemia [Срок оценки: Through study completion (Day 10 or the length of admission)]
• Hospital Complications [Срок оценки: Through study completion (Day 10 or the length of admission)]
• Recurrent hypoglycemia [Срок оценки: Through study completion (Day 10 or the length of admission)]
• Recurrent hyperglycemia [Срок оценки: Through study completion (Day 10 or the length of admission)]

Критерии участия

Критерии включения

• Known history of T1D treated with insulin therapy (human regular or rapid-acting analogs or ultra-rapid analogs \[lispro, aspart, glulisine, fast-acting insulin aspart, insulin lispro\]), intermediate-acting (NPH and premixed formulations) or long-acting basal (glargine, detemir, degludec) formulations.
• Admission diagnosis of T1D with poorly controlled diabetes (blood glucose > 180 mg/dl, HbA1c > 7%), including diabetic ketoacidosis (DKA) and hyperglycemic hyperosmolar state (HHS).
• Expected length of hospital stay > three days at the time of randomization

Критерии исключения

• Patients admitted to the ICU
• Subjects using CGM technology before admission
• Subjects with type 2 diabetes
• Treatment with systemic immunosuppressive agents
• Cystic fibrosis
• Prisoners
• Patients expected to require MRI procedures during hospitalization.
• Female subjects who are pregnant or breastfeeding at enrollment into the study.
• Subjects not willing to wear a CGM device
• Subjects with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension) and end-stage kidney disease (eGFR< 30 ml/min), or terminal illness.
• Subjects with a history of cognitive impairment, dementia, or mental condition rendering the subject unable to understand the nature and consequences of the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Grady Memorial Hospital — Atlanta

Идентификаторы

NCT: NCT06752928 · STUDY00008724

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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