Diabete Type 2, Hyperglycemia
Conditions
Keywords
Diabetes mellitus, hyperglycemia, hospitalization, treatment, hypoglycemia
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.
Interventions
DRUGInsulin
correction scheme with Rapid Acting Insulin Analogs according with the Umpierrez sensitive correction scheme
DRUGinsulin
correction scheme with Rapid Acting Insulin Analogs according with the Davidson correction scheme
Sponsors
Hospital Universitario Clinica San Rafael
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Unblinded, randomized, controlled clinical trial in patients with hyperglycemia and type 2 diabetes mellitus hospitalized
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of paticipants with Glicemic control | 5 hours | Glycemic control defined as glucose levels between 70 and 180 mg/dl measured with a glucometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with hypoglycemia | 6 hours | hypoglycemia defined as glucose levels less than 70 mg/dl measured with a glucometer |
Outcome results
None listed