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Status unknownNCT01406496Updated Feb 22, 2013

Best Timing of Insulin Bolus Before Meals of Different Contents

An interventional study of insulin in Type 1 Diabetes Mellitus, sponsored by Kaplan Medical Center. Status unknown at 1 site in Israel. Open to participants aged 8 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-02-22.

Sponsored by Kaplan Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
8 Years to 30 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 1 Diabetes Mellitus

Keywords

  • Insulin bolus
  • glucose excursions
  • post-prandial
  • timing
  • meal content
03

In context

Diabetes Mellitus, Type 1

3,521 studies on the registry are indexed under Diabetes Mellitus, Type 1; 576 are open to participants now.

This study's planned enrollment of 24 is below the median of 40 across 2,648 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Kaplan Medical Center is the lead sponsor of 37 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Diabetes patients:

  • Type 1 diabetes
  • Age 8 to 20 years
  • Both genders

Control group:

  • Age 18 to 30 years
  • Both genders

Exclusion criteria

Exclusion Criteria:

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Timing of insulin administration

    Drug: insulin

Interventions

  • Druginsulin

    Three different timings of insulin delivered by a pump

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

06

What researchers measure

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.

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

07

Study locations

1 of 1 sites recruiting
  • Pediatric Endocrinology Unit, Kaplan Medical Center
    Rehovot, 76100, Israel
    • Amnon Zung, MD · Contact · amnon_z@clalit.org.il · 972-8-9441260
    • Amnon Zung, MD · Principal investigator
    • Nitza Vazana, RN · Sub investigator
    • Lilach Hofi, R.Nutr · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01406496
Lead sponsor
Kaplan Medical Center
Responsible party
Amnon Zung (MD, Kaplan Medical Center) — Principal investigator
First posted
Aug 1, 2011
Start date
Aug 2011
Primary completion
Oct 2013 (estimated)
Completion
Dec 2013 (estimated)
Last update
Feb 22, 2013

Study contacts

Amnon Zung, MD
Contact
amnon_z@clalit.org.il
972-8-9441260
Amnon Zung, MD
principal investigator · Pediatric Endocrinology Unit, Kaplan Medical Center, affiliated with the Hebrew University of Jerusalem

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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