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TerminatedNCT00464854Updated Apr 24, 2007

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

An interventional study of Glargine and insulin aspart or lispro in Diabetes Mellitus, sponsored by Assaf-Harofeh Medical Center. Terminated at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-04-24.

Sponsored by Assaf-Harofeh Medical Center · Not applicable, Interventional, and Treatment

Why this study was terminated
The study was started before the official request for protocol registration
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Diabetes Mellitus

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Keywords

  • Glucose control
  • Subcutaneous insulin treatment
  • Multiple daily injections
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 100 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Assaf-Harofeh Medical Center is the lead sponsor of 258 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Diabetic ketoacidosis.
  • Hyperosmolar state due to hyperglycemia.
  • Pregnancy
  • Fertile women who do not use oral contraception or IUD
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants

Interventions

  • DrugGlargine and insulin aspart or lispro
06

What researchers measure

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)

07

Study locations

1 site
  • Assaf Harofe Medical Center
    Zerifin, 70300, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00464854
Lead sponsor
Assaf-Harofeh Medical Center
First posted
Apr 24, 2007
Start date
Jul 2005
Completion
Sep 2006
Last update
Apr 24, 2007

Study contacts

Andreas E Buchs, M.D.
principal investigator · Assaf Harofe Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

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