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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05752929
Other study ID # HUCSR20161
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 1, 2016
Est. completion date December 31, 2019

Study information

Verified date February 2023
Source Hospital Universitario Clinica San Rafael
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date December 31, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Insulin
correction scheme with Rapid Acting Insulin Analogs according with the Umpierrez sensitive correction scheme
insulin
correction scheme with Rapid Acting Insulin Analogs according with the Davidson correction scheme

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitario Clinica San Rafael

References & Publications (8)

Aschner P, King H, Triana de Torrado M, Rodriguez BM. Glucose intolerance in Colombia. A population-based survey in an urban community. Diabetes Care. 1993 Jan;16(1):90-3. doi: 10.2337/diacare.16.1.90. — View Citation

Davidson PC, Hebblewhite HR, Steed RD, Bode BW. Analysis of guidelines for basal-bolus insulin dosing: basal insulin, correction factor, and carbohydrate-to-insulin ratio. Endocr Pract. 2008 Dec;14(9):1095-101. doi: 10.4158/EP.14.9.1095. — View Citation

Escobedo J, Buitron LV, Velasco MF, Ramirez JC, Hernandez R, Macchia A, Pellegrini F, Schargrodsky H, Boissonnet C, Champagne BM; CARMELA Study Investigators. High prevalence of diabetes and impaired fasting glucose in urban Latin America: the CARMELA Stu — View Citation

Umpierrez GE, Hellman R, Korytkowski MT, Kosiborod M, Maynard GA, Montori VM, Seley JJ, Van den Berghe G; Endocrine Society. Management of hyperglycemia in hospitalized patients in non-critical care setting: an endocrine society clinical practice guidelin — View Citation

Umpierrez GE, Isaacs SD, Bazargan N, You X, Thaler LM, Kitabchi AE. Hyperglycemia: an independent marker of in-hospital mortality in patients with undiagnosed diabetes. J Clin Endocrinol Metab. 2002 Mar;87(3):978-82. doi: 10.1210/jcem.87.3.8341. — View Citation

Umpierrez GE, Smiley D, Hermayer K, Khan A, Olson DE, Newton C, Jacobs S, Rizzo M, Peng L, Reyes D, Pinzon I, Fereira ME, Hunt V, Gore A, Toyoshima MT, Fonseca VA. Randomized study comparing a Basal-bolus with a basal plus correction insulin regimen for t — View Citation

Umpierrez GE, Smiley D, Jacobs S, Peng L, Temponi A, Mulligan P, Umpierrez D, Newton C, Olson D, Rizzo M. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes undergoing general surgery (RABBIT 2 sur — View Citation

Umpierrez GE, Smiley D, Zisman A, Prieto LM, Palacio A, Ceron M, Puig A, Mejia R. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes (RABBIT 2 trial). Diabetes Care. 2007 Sep;30(9):2181-6. doi: 10. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Number of participants with hypoglycemia hypoglycemia defined as glucose levels less than 70 mg/dl measured with a glucometer 6 hours
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