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.
1 other identifier
interventional
36
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 diabetes-mellitus-type-2
Started Jun 2012
Typical duration for phase_4 diabetes-mellitus-type-2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2012
CompletedFirst Posted
Study publicly available on registry
May 8, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFebruary 28, 2018
September 1, 2016
2.3 years
May 7, 2012
February 27, 2018
Conditions
Study Arms (2)
sliding scale
ACTIVE COMPARATORbasal bolus
ACTIVE COMPARATORInterventions
4 shots of regular insulin: 3 before meals and one at bedtime.
1 shot glargine at bedtime 3 shots glulisine before meals
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2012
First Posted
May 8, 2012
Study Start
June 1, 2012
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
February 28, 2018
Record last verified: 2016-09