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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06253351
Acronym
BFHado
Enrollment
101
Registered
2024-02-12
Start date
2024-03-13
Completion date
2024-05-06
Last updated
2024-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescents, Type1 Diabetes, Young Adults

Keywords

type 1 diabetes, hybrid closed-loop, adolescents, young adults, HbA1c, TIR

Brief summary

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.

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.

Interventions

* Control IQ : T-Slim pump with Dexcom G6 * Smartguard : Medtronic 780G pump with Guardian G4S * Diabeloop : Kaliedo pump with Dexcom G6

Sponsors

Centre Hospitalier Sud Francilien
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 25 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
HbA1c after HCLat 3 monthsComparison of HbA1c (%) before and after HCL (at least 3 months of use)

Secondary

MeasureTime frameDescription
Use of HCLat 3 monthsPercentage of use of HCL
HCL stopat 3 monthsnumber of HCL stop
Glycemic parameters with CGMat 3 monthspourcentage time In Range (TIR) 70-180 mg/dl
HbA1c after HCLat 6 monthsComparison of HbA1c (%) before and after HCL (at least 3 months of use)
retinopathyat 3 monthsComparison of retinography results before HCL and after HCL
nephropathyat 3 monthsComparison microalbuminuria/creatininuria dosage the year before HCL and after HCL
keto-acidosis and severe hypoglycemiaat 3 monthsComparision of keto-acidose and severe hypoglycemia events the year before HCL and after HCL

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026