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

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ClinicalTrials.gov Identifier: NCT01594060
Recruitment Status : Completed
First Posted : May 8, 2012
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel

Tracking Information
First Submitted Date  ICMJE May 7, 2012
First Posted Date  ICMJE May 8, 2012
Last Update Posted Date February 28, 2018
Study Start Date  ICMJE June 2012
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Basal Bolus vs. Sliding Scale for Treatment of Diabetic Patients in Medical Wards
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus Type 2
Intervention  ICMJE
  • Drug: Insulin, regular - act rapid
    4 shots of regular insulin: 3 before meals and one at bedtime.
  • Drug: Insulin glulisine, Insulin glargine
    1 shot glargine at bedtime 3 shots glulisine before meals
Study Arms  ICMJE
  • Active Comparator: sliding scale
    Intervention: Drug: Insulin, regular - act rapid
  • Active Comparator: basal bolus
    Intervention: Drug: Insulin glulisine, Insulin glargine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September¬†7,¬†2016)
36
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01594060
Other Study ID Numbers  ICMJE 0042-12-EMC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party HaEmek Medical Center, Israel
Study Sponsor  ICMJE HaEmek Medical Center, Israel
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account HaEmek Medical Center, Israel
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP