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

Hospital General Universitario Gregorio Marañon

Status: Completed

Conditions: Hospitalization; Diabetes Mellitus Type 2

Treatments: Device: Experimental (Decision making guided by CGM)

Study type: Interventional

Funder types: Other

Identifiers

NCT06607224

ENDO2021-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Decision making guided by CGM

Experimental group

Description:

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

Treatment:

Device: Experimental (Decision making guided by CGM)

Decision making guided by CG

No Intervention group

Description:

Hospitalized patients with T2D admitted in non-critical medical and surgical wards. The participants use FreeStyle 2-CGM with deactivated alarms. Blind will be applied for patients, nurses and physicians in charge of the investigation. Concomitant 6-point CG controls will be performed (before each meal and two hours after meals) with Abbott FreeStyle Optium Neo glucometer. Insulin therapy adjustments will be carried out by GC only. The CGM values in this group will be evaluated a posteriori. Basal-bolus schedule with basal insulin Glargine U-100 and prandial insulin Aspart will be used. Daily adjustments will be made based on protocols of our department according to the international guidelines.