Comparison of 2 Hyperglycemia-correction Scales in Hospitalized Patients

Phase 4

Completed

• Conditions: Diabete Type 2; Hyperglycemia
• Interventions: Drug: insulin

• Registration Number: NCT05752929
• Lead Sponsor: Hospital Universitario Clinica San Rafael

Brief Summary

Hyperglycemia in the hospital is associated with multiple adverse outcomes. Previously, the mobile insulin scheme was used for its control. However, in the last decade, several studies have shown that the insulin basal-bolus (basal plus) regimen is associated with better glycemic control and a lower risk of hypoglycemia.

Detailed Description

Introduction:

Hyperglycemia in the hospital is associated with multiple adverse outcomes. Previously, the mobile insulin scheme was used for its control. However, in the last decade, several studies have shown that the insulin basal-bolus (basal plus) regimen is associated with better glycemic control and a lower risk of hypoglycemia.

Objective:

To compare the sensitive scheme of Umpierrez and the correction factor suggested by Davidson (1700/total dose of insulin) for the correction of hyperglycemia in patients with type 1 diabetes mellitus.

Methods:

Unblinded, randomized, controlled clinical trial in patients with hyperglycemia and type 2 diabetes mellitus hospitalized at a hospital in Bogotá, Colombia, between 2016 and 2018. A probabilistic sampling with randomly permuted blocks was performed. The Umpierrez sensitive correction scheme and the Davidson correction factor were compared by evaluating glycemic control at 2 and 5 hours, and the presence of hypoglycemia.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2019-12-31
• Status Verified: 2023-02
• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-21
• Last Update Submitted: 2023-02-21
• Study First Posted: 2023-03-03
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• Patients with diabetes mellitus who presented hyperglycemia (above 140 mg/dl) located in the general ward, emergency room or hospitalization and who received a basal or basal bolus insulin scheme.

Exclusion Criteria

• pregnancy, with acute decompensation of diabetes (diabetic ketoacidosis-hyperosmolar state) or type 1 diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Umpierrez	insulin	The Umpierrez sensitive correction scheme correction
Davidson	insulin	Davidson correction factor

Primary Outcome Measures

Name	Time	Method
Number of paticipants with Glicemic control	5 hours	Glycemic control defined as glucose levels between 70 and 180 mg/dl measured with a glucometer

Secondary Outcome Measures

Name	Time	Method
Number of participants with hypoglycemia	6 hours	hypoglycemia defined as glucose levels less than 70 mg/dl measured with a glucometer