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Completed

NCT Number: NCT06253351

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

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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Key information

Age range

15 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hybrid closed loop (HCL)

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

Primary outcomes

  1. HbA1c after HCL

    Time frame: at 3 months

    Comparison of HbA1c (%) before and after HCL (at least 3 months of use)

Secondary outcomes

  1. HbA1c after HCL

    Time frame: at 6 months

    Comparison of HbA1c (%) before and after HCL (at least 3 months of use)

  2. HbA1c after HCL

    Time frame: at 12 months

    Comparison of HbA1c (%) before and after HCL (at least 3 months of use)

  3. HbA1c after HCL

    Time frame: at 24 months

    Comparison of HbA1c (%) before and after HCL (at least 3 months of use)

  4. Use of HCL

    Time frame: at 3 months

    Percentage of use of HCL

  5. HCL stop

    Time frame: at 3 months

    number of HCL stop

  6. Glycemic parameters with CGM

    Time frame: at 3 months

    pourcentage time In Range (TIR) 70-180 mg/dl

  7. Glycemic parameters with CGM

    Time frame: at 3 months

    pourcentage time Below Range (TBR) < 70 mg/dl

  8. Glycemic parameters with CGM

    Time frame: at 3 months

    pourcentage Coefficient of Variation (CV)

  9. keto-acidosis and severe hypoglycemia

    Time frame: at 3 months

    Comparision of keto-acidose and severe hypoglycemia events the year before HCL and after HCL

  10. retinopathy

    Time frame: at 3 months

    Comparison of retinography results before HCL and after HCL

  11. nephropathy

    Time frame: at 3 months

    Comparison microalbuminuria/creatininuria dosage the year before HCL and after HCL

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Acronym: BFHado

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 12, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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