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Clinical Trials/NCT06305377
NCT06305377Not yet recruitingNot Applicable

Turning the Tides: Achieving Rapid, Safe and Sustained Glucose Control in Adolescents With Suboptimally Controlled Type 1 Diabetes Using Advanced Hybrid Closed Loop Systems

Giulio Frontino0 sites20 target enrollmentStarted: March 11, 2024Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
20
Primary Endpoint
Glucometric data
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The rational of this study is to assess if AHCL systems are able to achieve a better metabolic control (better glucometric data) after 2 weeks, 1 months. 6 months and 1 year after the start, in adolescents in not good glycaemic control.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Retrospective

Eligibility Criteria

Ages
12 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •All children met the American Diabetes Association (ADA) criteria for T1D diagnosis with a current HbA1c of ≥8.5%.
  • •Age range 12-17 yrs old

Exclusion Criteria

  • •Patients with a diagnose of genetic form of diabetes will be excluded.

Outcomes

Primary Outcomes

Glucometric data

Time Frame: 3 months

time in range 70-180 mg/dl

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Giulio Frontino
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Giulio Frontino

sub investigator

IRCCS San Raffaele

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