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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sliding scale

Group Type ACTIVE_COMPARATOR

Insulin, regular - act rapid

Intervention Type DRUG

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

basal bolus

Group Type ACTIVE_COMPARATOR

Insulin glulisine, Insulin glargine

Intervention Type DRUG

1 shot glargine at bedtime 3 shots glulisine before meals

Interventions

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Insulin, regular - act rapid

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

Intervention Type DRUG

Insulin glulisine, Insulin glargine

1 shot glargine at bedtime 3 shots glulisine before meals

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No