Clinical trial

Comparison of 2 Hyperglycemia-correction Scales in Hospitalized Patients in an Institution in Bogotá, Colombia

Name

HUCSR20161

Description

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.

Trial arms

Trial start

2016-01-01

Estimated PCD

2018-12-31

Trial end

2019-12-31

Status

Completed

Phase

Early phase I

Treatment

Insulin

correction scheme with Rapid Acting Insulin Analogs according with the Umpierrez sensitive correction scheme

Arms:

Umpierrez

Other names:

Umpierrez

insulin

correction scheme with Rapid Acting Insulin Analogs according with the Davidson correction scheme

Arms:

Davidson

Other names:

Davidson

Size

116

Primary endpoint

Number of paticipants with Glicemic control

5 hours

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Unblinded, randomized, controlled clinical trial in patients with hyperglycemia and type 2 diabetes mellitus hospitalized', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 116, 'type': 'ACTUAL'}}

Updated at

2023-03-03

1 organization

2 products

2 indications

Organization

Hospital Universitario Clínica San Rafael

Product

Indication

Indication

Product