Glucose Control With Multiple Daily Insulin Injections In Diabetic Patients Hospitalized In A General Medicine Ward
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Feasiblity, Safety And Efficacy Of Glucose Control With Multiple Daily Insulin Injections In Diabetic Patients Hospitalized In A General Medicine Ward|
- Achievement of a fasting blood glucose of 130 mg/dl and a mean daily glucose level of 180 mg/dl during hospitalization
- Hypoglycemia of < 60 mg% (symptomatic and asymptomatic)
|Study Start Date:||July 2005|
|Study Completion Date:||September 2006|
Location of the study:
Internal Medicine Wards C of Assaf Harofe Medical Center, Zerifin, Israel:
- Adult (<18 years) Male and female T1 & T2DM patients who can sign an informed consent.
- Insulin treatment (at least one injection a day) prior to hospitalization for at least half a year.
- Diabetic ketoacidosis.
- Hyperosmolar state due to hyperglycemia.
- Fertile women who do not use oral contraception or IUD
· The hospital staff will determine the initiation or continuation of oral and intravenous medications as indicated by the patient’s medical status.
Admission Blood tests:
- Routine: CBC, Creatinine, Urea, Na, K, GOT, GPT, Alp, Albumin, Glu
- HbA1C & Fructosamine.
Initiation and Titration of Insulin dosage:
- Glargine insulin will be initiated as a function of the first fasting glucose level and the patients body weight (0.3 - 0.8 U/kg). Up- or down titration will occur every morning by 10 - 20% according to capillary am fasting glucose (goal 130 mg%). The dosage of premeal insulin analogues will be based according to a sliding scale and calculated as a percentage of the amount of am glargine.
- Capillary blood glucose levels were measured seven times a day: before and two hours after breakfast, lunch and dinner and at bedtime. Additional measurements were performed according to clinical needs such as suspected hypoglycemia or unexplained deterioration of clinical condition
Please refer to this study by its ClinicalTrials.gov identifier: NCT00464854
|Assaf Harofe Medical Center|
|Zerifin, Israel, 70300|
|Principal Investigator:||Andreas E Buchs, M.D.||Assaf Harofe Medical Center|