Achieving Rapid, Safe and Sustained Glucose Control in Adolescents With Suboptimally Controlled Type 1 Diabetes Using Advanced Hybrid Closed Loop Systems
Turning the Tides: Achieving Rapid, Safe and Sustained Glucose Control in Adolescents With Suboptimally Controlled Type 1 Diabetes Using Advanced Hybrid Closed Loop Systems
1 other identifier
observational
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2024
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2024
CompletedStudy Start
First participant enrolled
March 11, 2024
CompletedFirst Posted
Study publicly available on registry
March 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2024
CompletedMarch 13, 2024
March 1, 2024
19 days
March 5, 2024
March 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Glucometric data
time in range 70-180 mg/dl
3 months
Interventions
Use of Tandem control IQ in a group of diabetic adolescents in not good glicaemic control
Eligibility Criteria
diabetics adolescents in not good glicaemic control
You may qualify if:
- 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
You may not qualify if:
- Patients with a diagnose of genetic form of diabetes will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Giulio Frontinolead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Riccardo Bonfanti, MD
IRCCS San Raffaele
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- sub investigator
Study Record Dates
First Submitted
March 5, 2024
First Posted
March 12, 2024
Study Start
March 11, 2024
Primary Completion
March 30, 2024
Study Completion
March 30, 2024
Last Updated
March 13, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share