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

April 23, 2007 updated by: Assaf-Harofeh Medical Center

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 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

Enrollment

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Zerifin, Israel, 70300
        • Assaf Harofe Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Hypoglycemia of < 60 mg% (symptomatic and asymptomatic)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Investigators

  • Principal Investigator: Andreas E Buchs, M.D., Assaf Harofe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

April 22, 2007

First Submitted That Met QC Criteria

April 23, 2007

First Posted (Estimate)

April 24, 2007

Study Record Updates

Last Update Posted (Estimate)

April 24, 2007

Last Update Submitted That Met QC Criteria

April 23, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AH-2323

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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