Comparison of 2 Hyperglycemia-correction Scales in Hospitalized Patients

Study Overview
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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.

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.

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

Conditions
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Diabete Type 2, Hyperglycemia

Intervention / Treatment
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* Drug: Insulin
* Drug: insulin


Participation Criteria
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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. Exclusion Criteria: pregnancy, with acute decompensation of diabetes (diabetic ketoacidosis-hyperosmolar state) or type 1 diabetes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Unblinded, randomized, controlled clinical trial in patients with hyperglycemia and type 2 diabetes mellitus hospitalized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Umpierrez<br>The Umpierrez sensitive correction scheme correction | Drug: Insulin<br>* correction scheme with Rapid Acting Insulin Analogs according with the Umpierrez sensitive correction scheme<br>* Other names: Umpierrez;|
| Experimental: Davidson<br>Davidson correction factor | Drug: insulin<br>* correction scheme with Rapid Acting Insulin Analogs according with the Davidson correction scheme<br>* Other names: Davidson;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of paticipants with Glicemic control | Glycemic control defined as glucose levels between 70 and 180 mg/dl measured with a glucometer | 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with hypoglycemia | hypoglycemia defined as glucose levels less than 70 mg/dl measured with a glucometer | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes mellitus, hyperglycemia, hospitalization, treatment, hypoglycemia