Effect of the Use of Continuous Glucose Monitoring Versus Standard Glycemic Control in Hospitalized Patients with Type 2 Diabetes.

Not Applicable

Completed

• Conditions: Diabetes Mellitus Type 2; Hospitalization

• 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.

Study Timeline

• Study Start: 2022-01-10
• Primary Completion: 2023-11-01
• Study Completion: 2024-01-30
• Status Verified: 2024-09
• Study First Submitted: 2024-09-05
• Study First Submitted QC: 2024-09-18
• Last Update Submitted: 2024-09-18
• Study First Posted: 2024-09-23
• Last Update Posted: 2024-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

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.

Trial Locations

Locations (1)

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain