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Basal Bolus vs. Sliding Scale for Treatment of Diabetic Patients in Medical Wards

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ClinicalTrials.gov Identifier: NCT01594060
Recruitment Status : Completed
First Posted : May 8, 2012
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel

Brief Summary:
A comparison of two treatment approaches for hyperglycemia in diabetic patients hospitalized in the medical department. The first approach is called basal-bolus in which 4 insulin shots are given daily ( 3 short acting before meals and one long acting before bed time). The second approach is called sliding scale in which short acting insulin alone is given before meals and before bed time according to the patient's glucose values. The aim is to keep fasting glucose between 140-180 mg/dl.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: Insulin, regular - act rapid Drug: Insulin glulisine, Insulin glargine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Comparative Study of Basal-bolus Insulin Versus Conventional Sliding-scale Regular Insulin Therapy in Management of Non-critically Ill Patients Hospitalized in the Medical Ward.
Study Start Date : June 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: sliding scale Drug: Insulin, regular - act rapid
4 shots of regular insulin: 3 before meals and one at bedtime.
Active Comparator: basal bolus Drug: Insulin glulisine, Insulin glargine
1 shot glargine at bedtime 3 shots glulisine before meals




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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients admitted to internal medicine ward with blood glucose (BG) between 140-400 mg/dl.
  • Known history (>6months) of diabetes.
  • Aged 18-80 years old.
  • Previous therapy including either diet alone or any combination of oral hypoglycemia agents, glucagon-like peptide 1 (GLP-1) analogs and long acting insulin analogs or Neutral Protamine Hagedorn (NPH).

Exclusion Criteria:

  • Pregnancy
  • Patients with ketoacidosis
  • Patients with unknown history of diabetes
  • Patients with type 1 diabetes mellitus
  • Patients with clinically relevant hepatic disease or renal impairment ( serum creatinine≥2.5 mg/dl)
  • Use of corticosteroid therapy
  • Patient with any mental disorder preventing him to cooperate and give informed consent.
  • Patients on multiple daily doses of insulin regimen.

Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01594060     History of Changes
Other Study ID Numbers: 0042-12-EMC
First Posted: May 8, 2012    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: September 2016

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin glulisine
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs