Glucose Control With Multiple Daily Insulin Injections In Diabetic Patients Hospitalized In A General Medicine Ward
|ClinicalTrials.gov Identifier: NCT00464854|
Recruitment Status : Terminated (The study was started before the official request for protocol registration)
First Posted : April 24, 2007
Last Update Posted : April 24, 2007
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus||Drug: Glargine and insulin aspart or lispro|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasiblity, Safety And Efficacy Of Glucose Control With Multiple Daily Insulin Injections In Diabetic Patients Hospitalized In A General Medicine Ward|
|Study Start Date :||July 2005|
|Study Completion Date :||September 2006|
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00464854
|Assaf Harofe Medical Center|
|Zerifin, Israel, 70300|
|Principal Investigator:||Andreas E Buchs, M.D.||Assaf Harofe Medical Center|