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

Diabetes Mellitus Type 2 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01594060
• Other study ID #: 0042-12-EMC
• Status: Completed
• Phase: Phase 4
• First received: May 7, 2012
• Last updated: February 27, 2018
• Start date: June 2012
• Est. completion date: October 2014

Study information

• Verified date: September 2016
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin, regular - act rapid
4 shots of regular insulin: 3 before meals and one at bedtime.
• Insulin glulisine, Insulin glargine
1 shot glargine at bedtime 3 shots glulisine before meals

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel