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

NCT ID: NCT06717841

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-09

Study Completion Date

2024-12-31

Brief Summary

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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

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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

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Type 1 Diabetes Mellitis Celiac Disease

Keywords

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Type 1 Diabetes Mellitus Celiac disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giulio Maltoni, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, , Italy

Site Status

Countries

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Italy

Other Identifiers

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CELTEC2020

Identifier Type: -

Identifier Source: org_study_id