Metabolic Control and Glycemic Variability in Type 1 Diabetes and Celiac Disease

December 1, 2024 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • patients with diabetes other than type1 diabetes;
  • patients not using the glycemic monitoring sensor.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020
glycemic variability coefficient
in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
time-in-range
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
glycemic variability coefficient
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
U/kg/die
in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Giulio Maltoni, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2020

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 1, 2024

First Submitted That Met QC Criteria

December 1, 2024

First Posted (Estimated)

December 5, 2024

Study Record Updates

Last Update Posted (Estimated)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 1, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CELTEC2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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