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

NCT00464854 | Terminated

• 1 other identifier: AH-2323
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Glucose control; Subcutaneous insulin treatment; Multiple daily injections

Outcome Measures

Primary Outcomes (1)

• Achievement of a fasting blood glucose of 130 mg/dl and a mean daily glucose level of 180 mg/dl during hospitalization

Secondary Outcomes (1)

• Hypoglycemia of < 60 mg% (symptomatic and asymptomatic)

Interventions

Glargine and insulin aspart or lispro DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Diabetic ketoacidosis.
• Hyperosmolar state due to hyperglycemia.
• Pregnancy
• Fertile women who do not use oral contraception or IUD

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Assaf Harofe Medical Center

Ẕerifin, 70300, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Glargine; Insulin Aspart; Insulin Lispro

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Study Officials

• Andreas E Buchs, M.D.

  Assaf Harofe Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 22, 2007
• First Posted: April 24, 2007
• Study Start: July 1, 2005
• Study Completion: September 1, 2006
• Last Updated: April 24, 2007

Record last verified: 2007-04

Locations

IL (1)