Type 1 DiabetesGLUTNCT01978704
Glycaemic Load and Pre-meal Insulin Doses in Type 1 Diabetes Patients
A study testing Adjustment of pre-prandial insulin doses on the bases of glycaemic load of the meal and Adjustment of pre-prandial insulin doses on the bases of carbohydrates content of the meal in people with Type 1 Diabetes, run by Federico II University.
Trial summary
The aim of this study is to compare the feasibility and the efficacy on short-term glucose control of pre-meal insulin doses adjustment made on the bases of the glycemic load or of the carbohydrates content of the meal in patients with type 1 diabetes mellitus treated with insulin pump Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Adjustment of pre-prandial insulin doses on the bases of glycaemic load of the meal and Adjustment of pre-prandial insulin doses on the bases of carbohydrates content of the meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Aug 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 18 to 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- Type 1 diabetes treated by insulin pump
Who cannot join
- Preganncy
- HbA1c > 9%
- Any serious acute or chronic illness a part diabetes
About this study
Official title: Use of the Glycemic Load for the Adjustment of the Dose of Preprandial Insulin in Patients With Type 1 Diabetes Mellitus in Insulin Pump Therapy
The aim of this study is to compare the feasibility and the efficacy on short-term glucose control of pre-meal insulin doses adjustment made on the bases of the glycemic load or of the carbohydrates content of the meal in patients with type 1 diabetes mellitus treated with insulin pump
- Conditions
- Type 1 Diabetes
- Being tested
- Adjustment of pre-prandial insulin doses on the bases of glycaemic load of the meal, Adjustment of pre-prandial insulin doses on the bases of carbohydrates content of the meal
- 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.
Adjustment of pre-prandial insulin doses on the bases of glycaemic load of the mealOther
Adjustment of pre-prandial insulin doses on the bases of carbohydrates content of the mealOther
| Study group | Role | What they receive |
|---|---|---|
| Glycaemic load | Experimental | Not described Receives: Other: Adjustment of pre-prandial insulin doses on the bases of glycaemic load of the meal |
| Carbohydrates content | Active comparator | Not described Receives: Other: Adjustment of pre-prandial insulin doses on the bases of carbohydrates content of the meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
daily plasma glucose excursion
Measured: 1 week
mean plasma glucose concentrations
Measured: 1 week
Secondary outcomes (1)
postprandial plasma glucose concentrations
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rivellese angela, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978704
- Sponsor's protocol ID
- 37/13
- Acronym
- GLUT
- Status last verified
- Nov 2013
- First submitted
- 1 Nov 2013
- Last updated
- 7 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Glycemic Load for the Adjustment of the Dose of Preprandial Insulin in Patients With Type 1 Diabetes Mellitus in Insulin Pump Therapy
- ClinicalTrials.gov ID
- NCT01978704
- Acronym / sponsor ID
- GLUT / 37/13
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 7 Nov 2013 (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.
The aim of this study is to compare the feasibility and the efficacy on short-term glucose control of pre-meal insulin doses adjustment made on the bases of the glycemic load or of the carbohydrates content of the meal in patients with type 1 diabetes mellitus treated with insulin pump
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glycaemic load | Experimental | Other: Adjustment of pre-prandial insulin doses on the bases of glycaemic load of the meal |
| Carbohydrates content | Active comparator | Other: Adjustment of pre-prandial insulin doses on the bases of carbohydrates content of the meal |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 1 diabetes treated by insulin pump
Key exclusion criteria (3 listed)
- Preganncy
- HbA1c > 9%
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 |
|---|---|---|
| Adjustment of pre-prandial insulin doses on the bases of glycaemic load of the meal | Other | Glycaemic load |
| Adjustment of pre-prandial insulin doses on the bases of carbohydrates content of the meal | Other | Carbohydrates content |
Primary outcome
daily plasma glucose excursion
Time frame: 1 week
mean plasma glucose concentrations
Time frame: 1 week
1 secondary outcome
postprandial plasma glucose concentrations
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Adjustment of pre-prandial insulin doses on the bases of glycaemic load of the meal and Adjustment of pre-prandial insulin doses on the bases of carbohydrates content of the meal in people with Type 1 Diabetes, run by Federico II University.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 7 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
daily plasma glucose excursion (time frame: 1 week). The study lists 2 primary outcomes in all. 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 7 Nov 2013; AzTrials last refreshed its copy on 6 Nov 2026.