Best Timing of Insulin Bolus Before Meals of Different Contents

NCT01406496 | Unknown DMC

• 1 other identifier: PP1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Post-meal glucose excursions may contribute to the development of diabetes-related complications. These glucose excursions are affected by the food content of the meal and the timing of insulin injection (or insulin pump-bolus) before meal. The best timing for insulin bolus (by pump) is controversial. The aim of the study is to examine three different timings of insulin bolus in three types of breakfast meals that contain carbohydrates, carbohydrates + proteins and carbohydrate+ fat. The 3h post-meal glucose excursions will be recorded by continuous glucose monitoring system. The results obtained in the diabetic patients will be compared to those obtained in a group of healthy individuals that will consume similar meals.

Conditions

Type 1 Diabetes Mellitus

Keywords

Insulin bolus; glucose excursions; post-prandial; timing; meal content

Outcome Measures

Primary Outcomes (1)

• Post-prandial blood glucose excursions following three different meals and three different timings of insulin bolus.

  Each diabetes patient will be assigned for one of three breakfast meals, differed by their content: carbohydrates, carbohydrates + proteins or carbohydrates + fat. Post-meal blood glucose excursions will be recoded by continuous blood glucose monitoring at three different days. In each day insulin bolus will be administrated at a different timing before meal. Each healthy participant will consume the three types of breakfast meals at three different days, and post-meal blood glucose excursions will be recoded by continuous blood glucose monitoring.

  outcome measures will be assessed for each particiapant after a week; the overall timeframe for all participants is 18 months

Study Arms (1)

Timing of insulin administration

EXPERIMENTAL

Drug: insulin

Interventions

insulin DRUG

Three different timings of insulin delivered by a pump

Also known as: Insulin Humalog (generic name Lispro), By Elli Lilly, USA

Timing of insulin administration

Eligibility Criteria

• Age: 8 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diabetes patients:
• Type 1 diabetes
• Age 8 to 20 years
• Both genders
• Control group:
• Age 18 to 30 years
• Both genders

You may not qualify if:

• Diabetes patients:
• Less than a year from the diagnosis of type 1 diabetes
• Less than 6 months from the time of insulin pump introduction
• Control group:
• Pregnancy
• Any diagnosed or suspected chronic diseases
• Current or recent (within 1 month) use of drugs (not including oral contraceptives and inhaled steroids for asthma).

Sponsors & Collaborators

• Kaplan Medical Center: lead

Study Sites (1)

Pediatric Endocrinology Unit, Kaplan Medical Center

Rehovot, 76100, Israel

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Amnon Zung, MD

  Pediatric Endocrinology Unit, Kaplan Medical Center, affiliated with the Hebrew University of Jerusalem

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amnon Zung, MD

CONTACT

972-8-9441260; amnon_z@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: August 1, 2011
• Study Start: August 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 22, 2013

Record last verified: 2013-02

Locations

IL (1)