search
Back to results

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
Hospital Universitario Clinica San Rafael
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabete Type 2 focused on measuring Diabetes mellitus, hyperglycemia, hospitalization, treatment, hypoglycemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    February 7, 2023
    Last Updated
    February 21, 2023
    Sponsor
    Hospital Universitario Clinica San Rafael
    search

    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

    Learn more about this trial

    Comparison of 2 Hyperglycemia-correction Scales in Hospitalized Patients

    We'll reach out to this number within 24 hrs