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

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.

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin, regular - act rapid

Drug

4 shots of regular insulin: 3 before meals and one at bedtime.

Insulin glulisine, Insulin glargine

Drug

1 shot glargine at bedtime 3 shots glulisine before meals

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Official study 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.

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: May 8, 2012
Registry last updated: Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed