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

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.

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus Type 2
• Intervention / Treatment: Drug: Insulin, regular - act rapid; Drug: Insulin glulisine, Insulin glargine

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: May 7, 2012
• First Submitted That Met QC Criteria: May 7, 2012
• First Posted (Estimate): May 8, 2012

Study Record Updates

• Last Update Posted (Actual): February 28, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin glulisine
• Other Study ID Numbers: 0042-12-EMC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No