Effect of the Use of Continuous Glucose Monitoring Versus Standard Glycemic Control in Hospitalized Patients with Type 2 Diabetes.
- Conditions
- Diabetes Mellitus Type 2Hospitalization
- Interventions
- Device: Experimental (Decision making guided by CGM)
- Registration Number
- NCT06607224
- Lead Sponsor
- Hospital General Universitario Gregorio Marañon
- Brief Summary
Type 2 diabetes (T2D) is a common pathology in hospitalized patients and is associated with multiple comorbidities. Moreover, it is widely known that glycemic excursions increase hospital stay, infections, morbidity and mortality. Likewise, asymptomatic hypoglycemia and stress hyperglycemia in hospitalized patients is more frequent due to intercurrent pathology, medication, alteration of counter-regulatory hormones. Therefore, the use of continuous glucose monitoring (CGM) systems would be very useful as it allows early recognition of glycemic excursions and thus improve the management of insulin therapy. The primary objective is to demonstrate the increase in time in range (TIR) with the use of CGM for insulin therapy adjustment in hospitalized patients with T2D during their admission. The investigators randomized, parallel group, 2-arm, 40 participants; 20 in each group, patients with diagnosis of T2D prior to admission.
- Detailed Description
Over the past few decades advances in diabetes technology have revolutionized patient care and metabolic control. The use of CGM has demonstrated substantial benefits on glycemic control in ambulatory patients compared to standard capillary blood glucose (CG) monitoring. However, in hospitalized patients, limitations on its use persist due to the lack of standardization of the data provided by CGM.
The use of CG has been the mainstay for monitoring and adjusting the treatment of hospitalized patients with diabetes. In the management for inpatients this test is commonly performed 3 to 4 times a day. However, this provides significant limitations due to its intermittent nature and the associated time burden for hospital nursing and ancillary staff for its determination.
Several studies have demonstrated that CGM detects more hyperglycemia and hypoglycemia in critically ill and non-critically ill patients. These studies have provided important information on patterns of glycemic control, with emphasis on early detection of glycemic excursions. However, there is still a need for further research to determine the efficacy of their use in glycemic adjustment, reliability in the hospital setting, and standardized protocols for their implementation and decision-making.
HYPOTHESIS The use of CGM allows an increase in TIR and improves the detection of clinically significant hypoglycemia and hyperglycemia in patients with T2D hospitalized on basal-bolus insulin therapy versus standard CG.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Over 18 years old
- Admitted to medical or surgical wards with an expected hospitalization duration of more than 72 hours
- Requiring basal-bolus insulin therapy during hospitalization.
- Pregnant women
- Severe mental illnesses
- Chronic use of high doses of ascorbic acid (equivalent to more than 500mg/day)
- Patients hospitalized in Intensive Care Units
- Severe cognitive impairment
- Prior outpatient CGM use
- Refusal of informed consent
- Patients on prolonged absolute diets or receiving artificial nutrition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Decision making guided by CGM Experimental (Decision making guided by CGM) Hospitalized patients with T2D in non-critical medical and surgical wards. The participants use FreeStyle 2-CGM and therapeutic decisions will be made based on CGM and GC parameters; with the presence of alarms for hypoglycemia or hyperglycemia activated for timely action. Blinded will be applied to patients; while the data will be open to the physicians in charge of the research in order to make daily modifications of insulin therapy. The CG controls will be of 6 points (before each meal and two hours after meals) with a standard Abbott FreeStyle Optium Neo glucometer. Basal-bolus scheme with basal insulin Glargine U-100 and prandial insulin Aspart will be used. Daily adjustments will be made based on protocol based of our department according to the international guidelines and previous research
- Primary Outcome Measures
Name Time Method The primary objective is to demonstrate the increase in TIR with the use of CGM for insulin therapy adjustment in hospitalized patients with T2D during their admission. The days of sensor use during hospitalization (from 3 to 14 days). -Time in range (TIR) reported at the end of sensor use: results will be expressed in percentages and levels greater than 70% will be considered good glycemic control.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain