Comparison of 2 Hyperglycemia-correction Scales in Hospitalized Patients

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabete Type 2 Hyperglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Unblinded, randomized, controlled clinical trial in patients with hyperglycemia and type 2 diabetes mellitus hospitalized

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Umpierrez

The Umpierrez sensitive correction scheme correction

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

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

Davidson

Davidson correction factor

Group Type EXPERIMENTAL

insulin

Intervention Type DRUG

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

Interventions

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Insulin

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

Intervention Type DRUG

insulin

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

Intervention Type DRUG

Other Intervention Names

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Umpierrez Davidson

Eligibility Criteria

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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.