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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2024-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Examining The Role of CGM in T2DM

NCT01614262

DIABETES MELLITUS, NONINSULIN-DEPENDENT, 2 (Disorder)

COMPLETED NA

Increasing CGM Use Among Patients With T2D

NCT06638099

Diabetes Diabetes Mellitus Diabetes Mellitus Type 2 +1 more

RECRUITING NA

Effect of Switching From Intermittently Scanned to Real-time Continuous Glucose Monitoring on Diabetes Management in Adults With Type 2 Diabetes (Switch CGM T2D)

NCT06805786

Type 2 Diabetes

RECRUITING

Professional Continuous Glucose Monitoring as an Adjuvant Educational Tool for Improving Glycemic Control in Patients With Type 2 Diabetes.

NCT04667728

Diabetes Mellitus, Type 2

COMPLETED NA

Continuous Glucose Monitoring (CGM) in Subjects With Type 2 Diabetes

NCT01341067

Type 2 Diabetes Mellitus

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus Type 2 Hospitalization

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Experimental (Decision making guided by CGM)

Intervention Type DEVICE

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.

Decision making guided by CG

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CGM

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No