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

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

Tracking Information

• First Submitted Date: May 7, 2012
• First Posted Date: May 8, 2012
• Last Update Posted Date: February 28, 2018
• Study Start Date: June 2012
• Actual Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Basal Bolus vs. Sliding Scale for Treatment of Diabetic Patients in Medical Wards
• 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.
• 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Diabetes Mellitus Type 2

Intervention

• 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

• Active Comparator: sliding scale
  Intervention: Drug: Insulin, regular - act rapid
• Active Comparator: basal bolus
  Intervention: Drug: Insulin glulisine, Insulin glargine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 7, 2016): 36
• Original Enrollment: Not Provided
• Actual Study Completion Date: October 2014
• Actual Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01594060
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: HaEmek Medical Center, Israel
• Study Sponsor: HaEmek Medical Center, Israel
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: HaEmek Medical Center, Israel
• Verification Date: September 2016