Comparison of 2 Hyperglycemia-correction Scales in Hospitalized Patients (CAPADOCIA1)
Primary Purpose
Diabete Type 2, Hyperglycemia
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Insulin
insulin
Sponsored by
About this trial
This is an interventional treatment trial for Diabete Type 2 focused on measuring Diabetes mellitus, hyperglycemia, hospitalization, treatment, hypoglycemia
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Umpierrez
Davidson
Arm Description
The Umpierrez sensitive correction scheme correction
Davidson correction factor
Outcomes
Primary Outcome Measures
Number of paticipants with Glicemic control
Glycemic control defined as glucose levels between 70 and 180 mg/dl measured with a glucometer
Secondary Outcome Measures
Number of participants with hypoglycemia
hypoglycemia defined as glucose levels less than 70 mg/dl measured with a glucometer
Full Information
NCT ID
NCT05752929
First Posted
February 7, 2023
Last Updated
February 21, 2023
Sponsor
Hospital Universitario Clinica San Rafael
1. Study Identification
Unique Protocol Identification Number
NCT05752929
Brief Title
Comparison of 2 Hyperglycemia-correction Scales in Hospitalized Patients
Acronym
CAPADOCIA1
Official Title
Comparison of 2 Hyperglycemia-correction Scales in Hospitalized Patients in an Institution in Bogotá, Colombia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Clinica San Rafael
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabete Type 2, Hyperglycemia
Keywords
Diabetes mellitus, hyperglycemia, hospitalization, treatment, hypoglycemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Unblinded, randomized, controlled clinical trial in patients with hyperglycemia and type 2 diabetes mellitus hospitalized
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Umpierrez
Arm Type
Active Comparator
Arm Description
The Umpierrez sensitive correction scheme correction
Arm Title
Davidson
Arm Type
Experimental
Arm Description
Davidson correction factor
Intervention Type
Drug
Intervention Name(s)
Insulin
Other Intervention Name(s)
Umpierrez
Intervention Description
correction scheme with Rapid Acting Insulin Analogs according with the Umpierrez sensitive correction scheme
Intervention Type
Drug
Intervention Name(s)
insulin
Other Intervention Name(s)
Davidson
Intervention Description
correction scheme with Rapid Acting Insulin Analogs according with the Davidson correction scheme
Primary Outcome Measure Information:
Title
Number of paticipants with Glicemic control
Description
Glycemic control defined as glucose levels between 70 and 180 mg/dl measured with a glucometer
Time Frame
5 hours
Secondary Outcome Measure Information:
Title
Number of participants with hypoglycemia
Description
hypoglycemia defined as glucose levels less than 70 mg/dl measured with a glucometer
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Mora
Organizational Affiliation
Hospital Universitario Clinica San Rafael
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23435159
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 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.
Results Reference
result
PubMed Identifier
22223765
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 guideline. J Clin Endocrinol Metab. 2012 Jan;97(1):16-38. doi: 10.1210/jc.2011-2098.
Results Reference
result
PubMed Identifier
19158048
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.
Results Reference
result
PubMed Identifier
8422838
Citation
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.
Results Reference
result
PubMed Identifier
11889147
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.
Results Reference
result
PubMed Identifier
21228246
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 surgery). Diabetes Care. 2011 Feb;34(2):256-61. doi: 10.2337/dc10-1407. Epub 2011 Jan 12.
Results Reference
result
PubMed Identifier
17513708
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: 10.2337/dc07-0295. Epub 2007 May 18.
Results Reference
result
PubMed Identifier
19719706
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 Study. Diabet Med. 2009 Sep;26(9):864-71. doi: 10.1111/j.1464-5491.2009.02795.x.
Results Reference
result
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Comparison of 2 Hyperglycemia-correction Scales in Hospitalized Patients
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