Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00464854
Status:
TERMINATED
Last Update Posted:
2007-04-24
First Post:
2007-04-22
Brief Title:
Glucose Control With Multiple Daily Insulin Injections In Diabetic Patients Hospitalized In A General Medicine Ward
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Assaf-Harofeh Medical Center
Study Overview
Official Title:
Feasiblity Safety And Efficacy Of Glucose Control With Multiple Daily Insulin Injections In Diabetic Patients Hospitalized In A General Medicine Ward
Status:
TERMINATED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was started before the official request for protocol registration
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
At least 20 of patients hospitalized in the general medical and surgical wards at any given time suffer from diabetes It has been demonstrated that poor clinical outcome correlates with the degree of hyperglycemia in these patients Strict glucose control in hospitalized patients improves clinical outcomes in the setting of acute myocardial infarction cardiac surgical procedures infection and critical illness in patients hospitalized in intensive care units if insulin is applied intravenously It is however complex to obtain strict glucose control in the general surgical and medical wards These wards are usually understaffed as compared to intensive care units and therefore are incapable to perform the necessary close monitoring essential in patients treated with intravenous insulin We intend to test the feasibility of glucose control by multiple daily subcutaneous injections with long acting basal glargine insulin and pre-meal insulin analogues If good glucose control can be achieved this would be a valid more convenient and acceptable alternative to intravenous insulin infusions to obtain good glucose control in diabetic patients hospitalized in general internal medicine wards
Detailed Description:
Location of the study
Internal Medicine Wards C of Assaf Harofe Medical Center Zerifin Israel
Inclusion Criteria
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
Exclusion Criteria
Diabetic ketoacidosis
Hyperosmolar state due to hyperglycemia
Pregnancy
Fertile women who do not use oral contraception or IUD
Concurrent medications
The hospital staff will determine the initiation or continuation of oral and intravenous medications as indicated by the patients 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 03 - 08 Ukg 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
Internal Medicine Wards C of Assaf Harofe Medical Center Zerifin Israel
Inclusion Criteria
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
Exclusion Criteria
Diabetic ketoacidosis
Hyperosmolar state due to hyperglycemia
Pregnancy
Fertile women who do not use oral contraception or IUD
Concurrent medications
The hospital staff will determine the initiation or continuation of oral and intravenous medications as indicated by the patients 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 03 - 08 Ukg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None