Type 1 Diabetes MellitusNCT01406496
Best Timing of Insulin Bolus Before Meals of Different Contents
A study testing insulin in people with Type 1 Diabetes Mellitus, run by Kaplan Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Diabetes patients:
- Type 1 diabetes
- Age 8 to 20 years
- Both genders
- Control group:
- Age 18 to 30 years
- Both genders
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Pediatric Endocrinology Unit, Kaplan Medical Center
Rehovot, 76100
Amnon Zung, MD, 972-8-9441260, amnon_z@clalit.org.il
Amnon Zung, MD
About this study
Official title: The Effect of Food Content and Optimal Timing of Pre-meal Insulin Bolus on the Postprandial Glycemic Control in Children With Type 1 Diabetes
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
- Being tested
- insulin
- Keywords
- Insulin bolus, glucose excursions, post-prandial, timing, meal content
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulinDrug
Also called Insulin Humalog (generic name Lispro), By Elli Lilly, USA
Three different timings of insulin delivered by a pump
| Study group | Role | What they receive |
|---|---|---|
| Timing of insulin administration | Experimental | Not described Receives: Drug: insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: outcome measures will be assessed for each particiapant after a week; the overall timeframe for all participants is 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amnon Zung, Kaplan Medical Center
- Investigators
- Amnon Zung, MD, Principal investigator, Pediatric Endocrinology Unit, Kaplan Medical Center, affiliated with the Hebrew University of Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406496
- Sponsor's protocol ID
- PP1
- Status last verified
- Feb 2013
- First submitted
- 16 Jun 2011
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Food Content and Optimal Timing of Pre-meal Insulin Bolus on the Postprandial Glycemic Control in Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01406496
- Acronym / sponsor ID
- PP1
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Insulin bolus, glucose excursions, post-prandial, timing, meal content
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 1 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Timing of insulin administration | Experimental | Drug: insulin |
Who may qualify
- Ages
- 8 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Type 1 diabetes
- Age 8 to 20 years
- Both genders
- Age 18 to 30 years
- Both genders
Key exclusion criteria (7 listed)
- Less than a year from the diagnosis of type 1 diabetes
- Less than 6 months from the time of insulin pump introduction
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insulinAlso: Insulin Humalog (generic name Lispro), By Elli Lilly, USAThree different timings of insulin delivered by a pump | Drug | Timing of insulin administration |
Primary outcome
Post-prandial blood glucose excursions following three different meals and three different timings of insulin bolus.
Time frame: outcome measures will be assessed for each particiapant after a week; the overall timeframe for all participants is 18 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amnon Zung, MD principal investigator
Pediatric Endocrinology Unit, Kaplan Medical Center, affiliated with the Hebrew University of Jerusalem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing insulin in people with Type 1 Diabetes Mellitus, run by Kaplan Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amnon Zung, MD (972-8-9441260, amnon_z@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-prandial blood glucose excursions following three different meals and three different timings of insulin bolus. (time frame: outcome measures will be assessed for each particiapant after a week; the overall timeframe for all participants is 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2013.