Type 1 Diabetes MellitisNCT06717841
Metabolic Control and Glycemic Variability in Type 1 Diabetes and Celiac Disease
An observational study of Type 1 Diabetes Mellitis and Celiac Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
This is an observational, retrospective study focused on differences of time-in-range and glycemic variability between a cohort of patients with both type 1 diabetes and celiac disease, and a cohort of patients with only type 1 diabetes. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Type 1 Diabetes Mellitis, Celiac Disease
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 9 Oct 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients aged < 18 years at enrollement with type 1 diabetes and celiac disease or with only type 1 diabetes, treated with continuous subcutaneous insulin infusion or multidaily injections and using the continuous glycemic monitoring sensor.
Who may be able to join
- patients < 18 years of age at enrollment;
- patients with type 1 diabetes onset since at least 1 year and celiac disease (COHORT A);
- patients only with type 1 diabetes onset since at least 1 year (COHORT B);
- using the continuous glycemic monitoring sensor;
- being on treatment with continuous subcutaneous insulin infusion or multidaily injections;
- obtaining informed consent from parents/legal guardian of pediatric patients.
Who cannot join
- patients with diabetes other than type1 diabetes;
- patients not using the glycemic monitoring sensor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Time-in-range and Glycemic Variability in Patients With Type 1 Diabates Mellitus and Celiac Disease With a Glycemic Monitoring Sensor
This is an observational, retrospective study focused on differences of time-in-range and glycemic variability between a cohort of patients with both type 1 diabetes and celiac disease, and a cohort of patients with only type 1 diabetes.
Read the detailed description
The study design provides for 2 cohorts of pediatric and adolescent patients using the continuous glycemic monitoring sensor. Cohort A consists of patients with type 1 diabetes and celiace disease, while cohort B consists of patients with only type 1 diabetes.
The primary aim of the study is to assess whether cohort A patients can achieve the same metabolic control and glycemic variability goals (expressed as Time-In-Range and glycemic Variability Coefficient) as cohort B patients.
The secondary aims are: assessing differences in Time-In-Range and glycemic Variability Coefficient between cohort A patients treated with multidaily injections, and those treated with continuous subcutaneous insulin infusion; assessing differences on total daily insulinic intake between cohort A and cohort B.
- Conditions
- Type 1 Diabetes Mellitis, Celiac Disease
- Keywords
- Type 1 Diabetes Mellitus, Celiac disease
- Medical subject headings
- Celiac Disease, Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences on metabolic control between cohort A and B
time-in-range
Measured: in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020
Differences on glycemic variability between cohort A and B
glycemic variability coefficient
Measured: in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020
Secondary outcomes (3)
Differences on metabolic control between patients on different therapeutic regimen
time-in-range
Measured: in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020
Differences on glycemic variability between patients on different therapeutic regimen
glycemic variability coefficient
Measured: in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020
Differences on total daily insulinic intake between cohort A and B
U/kg/die
Measured: in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start9 Oct 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (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 MellitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giulio Maltoni, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717841
- Sponsor's protocol ID
- CELTEC2020
- Status last verified
- Oct 2024
- First submitted
- 1 Dec 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Time-in-range and Glycemic Variability in Patients With Type 1 Diabates Mellitus and Celiac Disease With a Glycemic Monitoring Sensor
- ClinicalTrials.gov ID
- NCT06717841
- Acronym / sponsor ID
- CELTEC2020
- Conditions
- Type 1 Diabetes Mellitis, Celiac Disease
- Keywords
- Type 1 Diabetes Mellitus, Celiac disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Dec 2024 (actual)
- 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.
This is an observational, retrospective study focused on differences of time-in-range and glycemic variability between a cohort of patients with both type 1 diabetes and celiac disease, and a cohort of patients with only type 1 diabetes.
Detailed description
The study design provides for 2 cohorts of pediatric and adolescent patients using the continuous glycemic monitoring sensor. Cohort A consists of patients with type 1 diabetes and celiace disease, while cohort B consists of patients with only type 1 diabetes.
The primary aim of the study is to assess whether cohort A patients can achieve the same metabolic control and glycemic variability goals (expressed as Time-In-Range and glycemic Variability Coefficient) as cohort B patients.
The secondary aims are: assessing differences in Time-In-Range and glycemic Variability Coefficient between cohort A patients treated with multidaily injections, and those treated with continuous subcutaneous insulin infusion; assessing differences on total daily insulinic intake between cohort A and cohort B.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients aged < 18 years at enrollement with type 1 diabetes and celiac disease or with only type 1 diabetes, treated with continuous subcutaneous insulin infusion or multidaily injections and using the continuous glycemic monitoring sensor.
Key inclusion criteria (6 listed)
- patients < 18 years of age at enrollment;
- patients with type 1 diabetes onset since at least 1 year and celiac disease (COHORT A);
- patients only with type 1 diabetes onset since at least 1 year (COHORT B);
- using the continuous glycemic monitoring sensor;
- being on treatment with continuous subcutaneous insulin infusion or multidaily injections;
Key exclusion criteria (2 listed)
- patients with diabetes other than type1 diabetes;
- patients not using the glycemic monitoring sensor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences on metabolic control between cohort A and B
Time frame: in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020
time-in-range
Differences on glycemic variability between cohort A and B
Time frame: in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020
glycemic variability coefficient
3 secondary outcomes
Differences on metabolic control between patients on different therapeutic regimen
Time frame: in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020
Differences on glycemic variability between patients on different therapeutic regimen
Time frame: in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020
Differences on total daily insulinic intake between cohort A and B
Time frame: in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
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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.
Giulio Maltoni, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitis and Celiac Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 6 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2024. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
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?
Differences on metabolic control between cohort A and B (time frame: in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020). 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 5 Dec 2024; AzTrials last refreshed its copy on 29 Oct 2026.