Health Condition 1: E101- Type 1 diabetes mellitus with ketoacidosis
Conditions
Interventions
Intervention1: Early administration of subcutaneous Inj Glargine: Early administration of subcutaneous Inj Glargine 0.3units/kg single dose along with standard of care treatment for DKA which include
Sponsors
Aster Intramural funding
Eligibility
Inclusion criteria
Inclusion criteria: Males or females presenting with a known history of or presumed new onset type 1 diabetes with diabetic ketoacidosis. Diabetic ketoacidosis is defined as serum glucose more than 200 mg/dl, venous pH less than 7.3 or serum bicarbonate less than 15mmol/l, ketonemia which is blood beta-hydroxybutyrate levels more than or equal to 3mmol/l or moderate to large ketonuria
Exclusion criteria
Exclusion criteria: Participants who have begun insulin treatment prior to being approached for enrolment Participants with known diagnosis of type2 diabetes, other specific types such as monogenic diabetes, genetic defects in insulin action, diseases of exocrine pancreas, endocrinopathies, drug or chemical induced insulin resistance and deficiency Other genetic syndromes associated with diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time taken in hours for DKA resolution Number of patients with hypokalemia or serum potassium less than 3.5 meq/l Number of patients hypoglycemia or blood glucose less than 60 mg/dlTimepoint: DKA resolution- time taken in hours from start of IV insulin infusion to reaching a venous pH greater than or equal to 7.35 or venous bicarbonate greater than or equal to 15mmol/l Hypokalemia- from start of IV insulin till 24 hours post discontinuation Hypoglycemia- from start of IV insulin till 12 hours post discontinuation | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with rebound hyperglycemia defined as blood glucose greater than 180mg/dl Number of patients with rebound ketogenesis defined as blood beta-hydroxybutyrate greater than 1.5mmol/l Evaluation of CGM and point of care (POC) glucose monitoring during DKA treatmentTimepoint: Rebound hyperglycemia- within 12 hours after discontinuation of IV insulin Recurrent ketogenesis-within 12 hours after discontinuation of IV insulin Evaluation of CGM and POC glucose monitoring- during treatment of DKA and upto 1 week follow up after discharge | — |
Countries
India
Contacts
Public ContactDr Namratha Upadhya P Y
Aster CMI Hospital
Outcome results
None listed