None listed
Conditions
Brief summary
Diabetes mellitus is a highly prevalent disease worldwide and is considered a public health priority. It presents a higher risk of hospitalization compared to the general population, with a higher rate of complications and death. In hospitalization, poor metabolic control, whether due to hyperglycemia or hypoglycemia, and glycemic variability, is associated with adverse outcomes, including infections, prolonged hospital stay, intensive care unit admission, early readmission (less than 30 days), and death. Given this, we propose a randomized, controlled, open-label clinical trial in patients with type 2 diabetes in a general ward. We aim to compare the effectiveness and safety of supplemental insulin administration based on the total insulin dose with a correction factor for individual patient needs versus the regimen proposed by the Rabbit 2 studies.
Interventions
“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
“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.
Sponsors
Universidad de Caldas
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed