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

This study has been terminated.
(The study was started before the official request for protocol registration)
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00464854
First received: April 22, 2007
Last updated: April 23, 2007
Last verified: April 2007
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus
 Drug: Glargine and insulin aspart or lispro

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasiblity, Safety And Efficacy Of Glucose Control With Multiple Daily Insulin Injections In Diabetic Patients Hospitalized In A General Medicine Ward

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • 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:
  • Hypoglycemia of < 60 mg% (symptomatic and asymptomatic)

Estimated Enrollment: 100
Study Start Date: July 2005
Study Completion Date: September 2006
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00464854

Locations
Israel
Assaf Harofe Medical Center
Zerifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Andreas E Buchs, M.D. Assaf Harofe Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00464854     History of Changes
Other Study ID Numbers: AH-2323
Study First Received: April 22, 2007
Last Updated: April 23, 2007
Health Authority: Israel:Ethics Commission of the ministry of health

Keywords provided by Assaf-Harofeh Medical Center:
Glucose control
Subcutaneous insulin treatment
Multiple daily injections

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
 Glargine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013