Real-world Use of Hybrid Closed Loop in Adolescents and Young Adults 15-25 Years of Age With Type 1 Diabetes (BFHado)

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.

Study Overview

• Status: Recruiting
• Conditions: Type1 Diabetes; Adolescents; Young Adults
• Intervention / Treatment: Device: Hybrid closed loop (HCL)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Caroline TOURTE; Phone Number: 01 61 69 31 50; Email: caroline.tourte@chsf.fr
• Study Contact Backup: Name: Juliette EROUKHMANOFF, MD; Phone Number: 01 61 69 33 89; Email: juliette.eroukhmanoff@chsf.fr

Study Locations

• France
  • Corbeil-essonnes Cedex, France, 91106
    • Recruiting
    • Centre Hospitalier Sud Francilien
    • Contact: Juliette EROUKHMANOFF; Phone Number: 01 61 69 33 89; Email: juliette.eroukhmanoff@chsf.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Tertiary care center from Centre Hospitalier Sud Francilien

Description

Inclusion Criteria:

• Patient aged between 15 and 25 years old
• Type 1 diabetes since at least 1 year at the moment of instauring HCL
• At least 3 months of HCL use

Exclusion Criteria:

• Informed patient that have been opposed for their data collect

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group1; Patients between 15 and 25 years old with type 1 diabetes and treated by hybrid closed loop	Device: Hybrid closed loop (HCL); Control IQ : T-Slim pump with Dexcom G6; Smartguard : Medtronic 780G pump with Guardian G4S; Diabeloop : Kaliedo pump with Dexcom G6

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c after HCL	Comparison of HbA1c (%) before and after HCL (at least 3 months of use)	at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c after HCL	Comparison of HbA1c (%) before and after HCL (at least 3 months of use)	at 6 months
HbA1c after HCL	Comparison of HbA1c (%) before and after HCL (at least 3 months of use)	at 12 months
HbA1c after HCL	Comparison of HbA1c (%) before and after HCL (at least 3 months of use)	at 24 months
Use of HCL	Percentage of use of HCL	at 3 months
HCL stop	number of HCL stop	at 3 months
Glycemic parameters with CGM	pourcentage time In Range (TIR) 70-180 mg/dl	at 3 months
Glycemic parameters with CGM	pourcentage time Below Range (TBR) < 70 mg/dl	at 3 months
Glycemic parameters with CGM	pourcentage Coefficient of Variation (CV)	at 3 months
keto-acidosis and severe hypoglycemia	Comparision of keto-acidose and severe hypoglycemia events the year before HCL and after HCL	at 3 months
retinopathy	Comparison of retinography results before HCL and after HCL	at 3 months
nephropathy	Comparison microalbuminuria/creatininuria dosage the year before HCL and after HCL	at 3 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Sud Francilien
• Investigators: Principal Investigator: Juliette EROUKHMANOFF, MD, Centre Hospitalier Sud Francilien

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 2, 2024
• First Submitted That Met QC Criteria: February 9, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: HbA1c; adolescents; young adults; type 1 diabetes; hybrid closed-loop; TIR
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2023/0060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No