Pacients receiving enteral nutrition and who present hyperglycemia.
Conditions
Interventions
Trade Name: Apidra SoloStar
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: INSULIN GLULISINE
CAS Number: 207748-29-6
Concentration unit: IU/ml international unit(s)
Sponsors
Endocrinology and Nutrition Unit. Hospital Universitari Bellvitge.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients who receive tube feeding as the only way of nutrition. -Patients presenting hyperglycemia (> 140 mg / dl) on two consecutive occasions and in less than or equal to 48 hours. -Patients aged over 18 years. -Signing of informed consent by the patient and, if not possible, by the family and/or legal representative. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: -Patients in critical phase (admitted to the ICU, recovery unit, coronary care unit or stroke unit) -Patients who present creatinine over 200 mcmol/L -Patients with comorbidities that determine the use of a specific enteral formula (eg, cirrhosis, malabsorption syndrome) -Patients with type 1 diabetes mellitus. -Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare in terms of safety the use of insulin analogues versus human insulin in stable patients hospitalized outside intensive care units who require enteral nutrition, based on the development of hypoglycemia. To compare the efficacy of insulin analogues versus human insulin in this group of patients in glycemic control of patients.;Secondary Objective: 1.To compare the efficacy and safety of insulin analogues vs. human insulin in the first 72 hours after the first dose of insulin received after randomization. 2.To evaluate the differentiating characteristics for efficacy and safety between the following subgroups: -Obese patients (BMI> 30 kg/m2) versus non-obese (BMI <30 kg/m2). -Patients with previous known diabetes mellitus with respect to patients with undiagnosed diabetes -Patients on concomitant treatment with glucocorticoid vs patients without glucocorticoids. 3.To compare nutritional evolution of patients in both study groups, in patients receiving insulin treatment after randomization for a period equal to or greater than one week. 4.To compare glycemic variability in patients with insulin analogues compared with patients receiving human insulins. 5.To compare the frequency of metabolic complications in both groups.;Primary end point(s): The main assessment of safety is measured by the percentage of patients in both groups with at least one hypoglycemia (<70mg/dl) during the intervention period and by the rate of hypoglycemias/day of each group, defined as the addition of the number of hypoglycemia (<70mg/dl) of the patients divided by the number of days of monitoring. The main efficacy assessment will be measured by the proportion of glycemic control, defined for each patient as the ratio between the number of measurements of glucose within the desired range and the total number of measurements taken during the intervention period of the patient. The desired range is defined as: - Intermittent enteral nutrition (NEI): - Pri | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety: -Percentage of patients with severe hypoglycemia (<40 mg/dl). -Total number of hypoglycemia (<70mg/dl) per group and per patient. -Number of severe hypoglycemia (<40mg/dl) per group and per patient. -Severe hypoglycemia rate, defined as the number of severe hypoglycemia (<40mg/dl) of the patient divided by the number of days of monitoring. -Presence of metabolic complications: Infectious, Gastrointestinal, Cardiovascular, Other, death. Efficacy: -Total number of capillary blood glucose within the desired range by group and patient. - Rate of glycemic control/day, defined as the number of patient blood glucose within the range divided by the number of days of monitoring. -Mean daily glucose. -Glycemic variability (MAGE) -Insulin dose during admission -Nutritional assessment of the patient: malnutrition will be classified in caloric, proteic or mixed and in each one there will be three categories: mild, moderate or severe. -Time to stabilization of glycemic control. -Percentage of patients in both groups who are discharged within 14 days after randomization.;Timepoint(s) of evaluation of this end point: Last visit. | — |
Countries
Spain
Contacts
Public ContactMaria Núria Virgili Casas
Endocrinology and Nutrition Unit. Hospital Universitari Bellvitge.
Outcome results
None listed