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

NCT06607224 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-09-23

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus Type 2
  • Hospitalization

Interventions

DEVICE

Experimental (Decision making guided by CGM)

Patients use FSL2 and a smartphone. Libreview app will be used to assess interstitial glucose, alarms, and trend arrows, and LibreLinkUp app for research team. Concurrently, CG will be performed using the FreeStyle Optium Neo glucometer from Abbott. The nursing staff will be trained to manage and respond to alarms and trend arrows according to established protocols. The basal insulin adjustment protocol establishes with fasting and premeal targets between 140-180 mg/dL. For prandial insulin, corrective guidelines set according to each patient sensitivity factor, with additional adjustments for the intervention group based on trend arrows. The hypoglycemia alarm sets below 85 mg/dL. If activated, nursing staff will confirm the value via CG. If values are below 70 mg/dL, follow hypoglycemia protocol and if below 100 mg/dL with a descending trend arrow, 15 grams of slow-acting carbs. The hyperglycemia alarm will be set above 300 mg/dL and nurse inform investigators to make decisions.

Sponsors & Collaborators

  • Hospital General Universitario Gregorio Marañon

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-10
Primary Completion
2023-11-01
Completion
2024-01-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06607224 on ClinicalTrials.gov