Comparison of 2 Hyperglycemia-correction Scales in Hospitalized Patients

NCT05752929 | Completed Phase 4

• 1 other identifier: HUCSR20161
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabete Type 2; Hyperglycemia

Keywords

Diabetes mellitus; hyperglycemia; hospitalization; treatment; hypoglycemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants with hypoglycemia

  6 hours

Study Arms (2)

Umpierrez

ACTIVE COMPARATOR

The Umpierrez sensitive correction scheme correction

Drug: Insulin

Davidson

EXPERIMENTAL

Davidson correction factor

Drug: insulin

Interventions

insulin DRUG

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

Also known as: Umpierrez

Umpierrez

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitario Clinica San Rafael: lead

Related Publications (8)

• 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 the hospital management of medical and surgical patients with type 2 diabetes: basal plus trial. Diabetes Care. 2013 Aug;36(8):2169-74. doi: 10.2337/dc12-1988. Epub 2013 Feb 22.

  PMID: 23435159 RESULT

• 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 guideline. J Clin Endocrinol Metab. 2012 Jan;97(1):16-38. doi: 10.1210/jc.2011-2098.

  PMID: 22223765 RESULT

• 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.

  PMID: 19158048 RESULT

• 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.

  PMID: 8422838 RESULT

• 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.

  PMID: 11889147 RESULT

• 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 surgery). Diabetes Care. 2011 Feb;34(2):256-61. doi: 10.2337/dc10-1407. Epub 2011 Jan 12.

  PMID: 21228246 RESULT

• 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: 10.2337/dc07-0295. Epub 2007 May 18.

  PMID: 17513708 RESULT

• 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 Study. Diabet Med. 2009 Sep;26(9):864-71. doi: 10.1111/j.1464-5491.2009.02795.x.

  PMID: 19719706 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia; Diabetes Mellitus; Hypoglycemia

Interventions

Insulin; Connor-Davidson Resilience Scale

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Javier Mora

  Hospital Universitario Clinica San Rafael

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, cinical professor in internal medicine

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

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: March 3, 2023
• Study Start: January 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2019
• Last Updated: March 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share