Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91106, France
NCT Number: NCT06253351
The purpose of this study is to determine the effect of hybrid closed loop on glycemic outcomes in young patients aged between 15 and 25 years old with type 1 diabetes, whatever is their initial metabolic control.
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Notify Me15 year–25 year
All sexes
Observational
Corbeil-Essonnes, 91106, France
Type 1 diabetes (T1D) constitutes a major public health challenge due to acute complications requiring emergency hospitalizations, as well as many chronic complications that need to be managed over the long term. However, these complications can be prevented by maintaining correct glycemic control, according to international guidelines.
For the past few years, the arrival of new technologies as insulin pump and particularly Continuous Glucose Monitoring (CGM) showed a significant improvement on metabolic control.
Nevertheless, adolescents and young adults with type 1 diabetes need a special focus because they still fail to meet glycemic control targets.
At this time, hybrid closed loop, pairing Continuous Glucose Monitoring with insulin pump, enables insulin delivery in a semi-autonomous way thanks to algorithms, and leads to the best metabolic results we've never got in randomized trials and real-world studies.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: at 3 months
Comparison of HbA1c (%) before and after HCL (at least 3 months of use)
Time frame: at 6 months
Comparison of HbA1c (%) before and after HCL (at least 3 months of use)
Time frame: at 12 months
Comparison of HbA1c (%) before and after HCL (at least 3 months of use)
Time frame: at 24 months
Comparison of HbA1c (%) before and after HCL (at least 3 months of use)
Time frame: at 3 months
Percentage of use of HCL
Time frame: at 3 months
number of HCL stop
Time frame: at 3 months
pourcentage time In Range (TIR) 70-180 mg/dl
Time frame: at 3 months
pourcentage time Below Range (TBR) < 70 mg/dl
Time frame: at 3 months
pourcentage Coefficient of Variation (CV)
Time frame: at 3 months
Comparision of keto-acidose and severe hypoglycemia events the year before HCL and after HCL
Time frame: at 3 months
Comparison of retinography results before HCL and after HCL
Time frame: at 3 months
Comparison microalbuminuria/creatininuria dosage the year before HCL and after HCL
Centre Hospitalier Sud Francilien
Other
Acronym: BFHado
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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