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

Phase 4

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: Insulin glulisine, Insulin glargine; Drug: Insulin, regular - act rapid

• Registration Number: NCT01594060
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-07
• Study First Submitted QC: 2012-05-07
• Study First Posted: 2012-05-08
• Study Start: 2012-06
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2016-09
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
basal bolus	Insulin glulisine, Insulin glargine	-
sliding scale	Insulin, regular - act rapid	-