Glucose Control With Multiple Daily Insulin Injections In Diabetic Patients Hospitalized In A General Medicine Ward

Diabetes Mellitus Clinical Trial

Official title:

Feasiblity, Safety And Efficacy Of Glucose Control With Multiple Daily Insulin Injections In Diabetic Patients Hospitalized In A General Medicine Ward

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00464854
• Other study ID #: AH-2323
• Status: Terminated
• Phase: N/A
• First received: April 22, 2007
• Last updated: April 23, 2007
• Start date: July 2005
• Est. completion date: September 2006

Study information

• Verified date: April 2007
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel:Ethics Commission of the ministry of health
• Study type: Interventional

Clinical Trial 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.

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 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Glargine and insulin aspart or lispro

Locations

Country	Name	City	State
Israel	Assaf Harofe Medical Center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement of a fasting blood glucose of 130 mg/dl and a mean daily glucose level of 180 mg/dl during hospitalization
Secondary	Hypoglycemia of < 60 mg% (symptomatic and asymptomatic)