Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000957493
Ethics application status
Approved
Date submitted
24/06/2025
Date registered
1/09/2025
Date last updated
1/09/2025
Date data sharing statement initially provided
1/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the Rabbit2 regimen vs. the “Total Insulin Dose-Based Correction Factor” for the administration of corrective insulin in type 2 diabetic patients hospitalized in the general ward.
Scientific title
Comparison of efficacy and safety between the Rabbit2 regimen vs. the "Total Insulin Dose-Based Correction Factor" for the administration of corrective insulin in type 2 diabetic patients hospitalized in the general ward.
Secondary ID [1] 314728 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 2 diabetes 337930 0
Condition category
Condition code
Metabolic and Endocrine 334253 334253 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
“Total Insulin Dose-Based Correction Factor” for the administration of corrective insulin in type 2 diabetic patients hospitalized.
A specific ward will be selected in the SES Hospitalization Department. Upon identifying a patient who meets the inclusion criteria, the first step will be to discontinue oral antidiabetic medications.
In patients without prior insulin treatment, the protocol will be initiated if their fasting or preprandial blood glucose level is >140 mg/dL. The total insulin dose to be administered will depend on the initial blood glucose level:
- 0.4 U/kg/day if the blood glucose level on admission is between 140 and 200 mg/dL and 0.5 U/kg/day if the blood glucose level on admission is between 201 and 400 mg/dL.
The total insulin dose will be divided into 50% insulin glargine and 50% insulin glulisine, distributed between the three main meals. Both insulins will be administered via subcutaneous injection by the nursing staff.
A patient with a previous insulin regimen will only be adjusted if their total insulin dose is > 0.4 U/kg/day, in which case the dose will be reduced by 10%.
The Correction Factor will then be estimated as follows: Divide 1700 by the total insulin dose (TID).
The corrective insulin bolus should be calculated as (blood glucose level (mg/dL) – target glucose level (120) / correction factor).
- If the value is less than or equal to 0.5, apply the nearest number below (e.g., 4.5u = 4.0u).
- If the value is greater than or equal to 0.6, apply the nearest number above (e.g., 4.6u = 5.0u).
Administer the programmed bolus plus the corrective bolus via DTI by subcutaneous injection.
The insulin scale using TID will be adjusted:
- If the pre-meal or bedtime plasma glucose is persistently greater than 140 mg/dL on two or more measurements in the absence of hypoglycemia the previous day, recalculate by 1500.
- If a patient develops hypoglycemia (blood glucose less than 60 mg/dL), recalculate by 2000.
Patients will receive 3 meals with a fixed carbohydrate diet in each segment (breakfast, lunch, and dinner) tailored to the patient's needs. Snacks will consist of hydration with water, tea, or aromatic herbs, or less than 15 to 20 grams of carbohydrates.
The minimum intervention time is 3 days to a maximum of 14 days. The duration of the intervention will begin at the time of patient enrollment to the study and will continue throughout the patient's hospitalization, up to a maximum of 14 days.
Intervention code [1] 331333 0
Treatment: Drugs
Comparator / control treatment
The Basal-Bolus Regimen (RABBIT) will be used, which begins with the discontinuation of all oral or injectable antidiabetic medications other than insulin upon patient admission.
In patients without prior insulin treatment, the protocol will be initiated if their fasting or preprandial blood glucose level is >140 mg/dL. The total insulin dose to be administered will depend on the initial blood glucose level:
- 0.4 U/kg/day if the blood glucose level on admission is between 140 and 200 mg/dL and 0.5 U/kg/day if the blood glucose level on admission is between 201 and 400 mg/dL.
The total insulin dose will be divided into 50% insulin glargine and 50% insulin glulisine, distributed between the three main meals. Both insulins will be administered via subcutaneous injections by the nursing staff. The dose of basal glargine administered will be the same as the RABBIT regimen.
A patient with a previous insulin regimen will only be adjusted if their total insulin dose is > 0.4 U/kg/day, in which case the dose will be reduced by 10%.
In patients over 70 years of age or with serum creatinine greater than or equal to 2.0 mg/dL, a reduced dose of 0.3 U/kg is recommended.
If the patient is unable to eat, insulin glulisine should be discontinued.
Additionally, supplemental insulin glulisine is used according to a sliding scale if glucose exceeds 140 mg/dL. If the patient is adequately fed, supplemental insulin is administered before each meal and at bedtime, following the "usual" scale. If the patient cannot eat, the dose is administered every 6 hours, following the "sensitive" scale. The correction scale includes three categories: sensitive, habitual, and resistant, with progressively higher doses depending on the estimated degree of insulin resistance.
The daily adjustment of the insulin total daily dose is based on fasting glucose levels. If the glucose is between 100-140 mg/dL and there is no prior hypoglycemia, no changes are made. If it is between 140-180 mg/dL, the dose is increased by 10%; if it is greater to 180 mg/dL, it is increased by 20%. Conversely, if it is between 70-99 mg/dL, it is reduced by 10%, and if hyperglycemia is present (140 mg/dL on two or more occasions without hypoglycemia), the patient is switched to a more intensive titration. If hypoglycemia occurs (<60 mg/dL), the patient is switched back to a less intensive titration.
Treatment of hypoglycemia in conscious patients consists of administering 15 to 20 grams of rapidly absorbed carbohydrates, repeating the blood glucose test in 15 to 20 minutes, and continuing the cycle until levels exceed 70 mg/dL.
Insulins will be administered subcutaneously by the nursing staff. Basal insulin (glargine) will be administered once a day, while insulin glargine will be administered three times daily with meals, or every six hours if the patient cannot eat. The minimum duration of the intervention is three days, and the maximum is 14 days. The duration of the intervention will begin at the time of patient enrollment to the study and will continue throughout the patient's hospitalization, up to a maximum of 14 days.
Control group
Active

Outcomes
Primary outcome [1] 341924 0
Glycemic control
Timepoint [1] 341924 0
minimum intervention time of 3 days to a maximum of 14 days after randomisation
Secondary outcome [1] 449022 0
Glycemic variability
Timepoint [1] 449022 0
minimum intervention time of 3 days to a maximum of 14 days after randomisation
Secondary outcome [2] 449023 0
Hypoglycemia
Timepoint [2] 449023 0
minimum intervention time of 3 days to a maximum of 14 days after randomisation

Eligibility
Key inclusion criteria
• Age: Adult patients 18 years of age or older.
• Known history of type 2 diabetes mellitus for at least 3 months prior to hospitalization.
• Hospitalized in the general ward of the SES (Medical Center of the University Hospital of Caldas).
• Not expected to require admission to the intensive care unit (ICU) at the start of hospitalization.
• Capillary or plasma glucose between 140 and 400 mg/dL at the time of inclusion in the study.
• Previous treatment with: Diet and exercise only. Oral antidiabetic agents, either monotherapy or in combination. Low-dose insulin therapy (less than or equal to 0.6 units/kg/day).
• Capacity to Consent: Patients who can provide informed consent themselves or, if applicable, through a legally authorized representative.
• Estimated Hospital Stay: The patient is expected to be hospitalized for at least 72 hours after inclusion in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with type 1 diabetes mellitus or specific forms of diabetes other than type 2.
• Stress hyperglycemia without a prior diagnosis of diabetes.
• Patients scheduled for surgery.
• Treatment with systemic corticosteroids or their use is expected during hospitalization.
• Serum creatinine greater than or equal to 3.0 mg/dL or patients on renal replacement therapy (hemodialysis or peritoneal dialysis).
• Severe liver disease (e.g., cirrhosis with ascites, encephalopathy).
• Pregnant or breastfeeding women.
• Cognitive or psychiatric disorders that prevent understanding or following the study protocol, or providing informed consent.
• Allergies or Severe Adverse Reactions to Insulin: Known history of severe allergic reactions to human insulin or insulin analogues used in the study.
• Substance Use: Active alcohol or illicit drug abuse that may interfere with treatment adherence or monitoring.
• Terminal Illness or Limited Prognosis: Diagnosis of an unrelated terminal illness that limits life expectancy to less than 6 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization sequence will be generated using permuted blocks of size 4, using the "Random Permutation Generator" application from randomization.org.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
1/06/2026
Actual
Date of last data collection
Anticipated
1/10/2026
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 27137 0
Colombia
State/province [1] 27137 0
Caldas

Funding & Sponsors
Funding source category [1] 319280 0
Charities/Societies/Foundations
Name [1] 319280 0
"Asociación Colombiana de Endocrinología"
Country [1] 319280 0
Colombia
Primary sponsor type
University
Name
Universidad de Caldas
Address
Country
Colombia
Secondary sponsor category [1] 321754 0
Hospital
Name [1] 321754 0
SES Hospital de Caldas
Address [1] 321754 0
Country [1] 321754 0
Colombia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317857 0
Comités de Ética de la Investigación e Investigaciones de Servicios Especiales de Salud Hospital Universitario de Caldas
Ethics committee address [1] 317857 0
Ethics committee country [1] 317857 0
Colombia
Date submitted for ethics approval [1] 317857 0
30/09/2024
Approval date [1] 317857 0
06/02/2025
Ethics approval number [1] 317857 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142374 0
Dr Edwin Mora Garzón
Address 142374 0
Universidad de Caldas, Carrera 25 No. 48-57, Manizales, Caldas poscode 170004
Country 142374 0
Colombia
Phone 142374 0
+57 3002687942
Fax 142374 0
Email 142374 0
[email protected]
Contact person for public queries
Name 142375 0
Jorge Luis Cortés Navarro
Address 142375 0
Universidad de Caldas, Carrera 25 No. 48-57, Manizales, Caldas poscode 170004
Country 142375 0
Colombia
Phone 142375 0
+57 3103632591
Fax 142375 0
Email 142375 0
[email protected]
Contact person for scientific queries
Name 142376 0
Jorge Luis Cortés Navarro
Address 142376 0
Universidad de Caldas, Carrera 25 No. 48-57, Manizales, Caldas poscode 170004
Country 142376 0
Colombia
Phone 142376 0
+57 3103632591
Fax 142376 0
Email 142376 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.