An interventional study of Experimental (Decision making guided by CGM) in Diabetes Mellitus Type 2 and Hospitalization, sponsored by Hospital General Universitario Gregorio Marañon. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-23.
Sponsored by Hospital General Universitario Gregorio Marañon · Not applicable, Interventional, and Treatment
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 40 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
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
Device: Experimental (Decision making guided by CGM)
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.
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.
Also known as: CGM
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.
-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.
Time frame: The days of sensor use during hospitalization (from 3 to 14 days).
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Hospital General Universitario Gregorio Marañon