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NCT Number: NCT06919029

Effect of Advanced Hybrid Closed Loop System, MiniMed 780G in Newly Diagnosed Children and Adolescents With Type 1 Diabetes on Glycemic Control and Patient Reported Outcomes Compared to Standard Insulin Therapy Historical Data (AHCL in New Onset T1D Children Study)

The objective of this study is to evaluate glycemic control of users of the AHCL system MiniMed 780G with GS4 calibration-free sensor in children and adolescents with newly diagnosed T1D implemented directly upon T1D diagnosis in combination with continuous glucose monitoring system (CGMS) compared with those treated with MDI retrieved from historical data- in a single- arm open-label prospective observational study, assessed at 3 months. After the initial study period there will be a 3month extension phase of the study.

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Key information

Conditions

Diabetes Mellitus, Type I Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First Department of Pediatrics, National and Kapodistrian University of Athens, Medical School, "Aghia Sophia" Children's Hospital

Athens, 11527, Greece

Location status: Recruiting

Location contact

Alexandra Tsigkri

SUB_INVESTIGATOR

Christina Kanaka- Gantenbein, Professor

PRINCIPAL_INVESTIGATOR

Eleni Angelopoulou

SUB_INVESTIGATOR

Ioanna Gkika

SUB_INVESTIGATOR

Ioanna Tokou

SUB_INVESTIGATOR

Ioannis- Anargyros Vasilakis, PhD

CONTACT

[email protected]

00302107467583

Ioannis- Anargyros Vasilakis, PhD

SUB_INVESTIGATOR

Maria Michou

SUB_INVESTIGATOR

Sophia Sakka, Asst. Prof.

SUB_INVESTIGATOR

Vassia Chioti

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of type 1 diabetes (WHO criteria). Diagnosis of type 1 diabetes is based on international criteria and the investigator's judgment; C peptide level and antibody determinations are not required.
  • Age range 7 to 17 years.
  • Literate in Greek or English.
  • Willing to wear study devices.
  • Willing to follow study-specific instructions.
  • Total daily insulin dose greater than 8.0 units over 1 week period
  • Willing and able (access to internet from home) to download information into the Medtronic CareLink software
  • Clinically eligible to start the AHCL system

Exclusion criteria

  • Type 2 diabetes mellitus or MODY diabetes
  • Any untreated comorbidities of type 1 diabetes
  • Medication affecting metabolic control or interfering in the interpretation of HbA1c
  • Pregnancy
  • Untreated diabetes retinopathy, or other causes that in the investigator's opinion, precludes the individual from participating in the trial.
  • Known or suspected allergy to insulin.
  • Regular use of acetaminophen.
  • Lack of reliable telephone facility for contact.
  • Living alone.
  • Severe visual or hearing impairment.
  • Medically documented allergy to the adhesive of plasters or unable to tolerate tape adhesive around sensor placement.
  • Serious skin lesions at areas of the body used for insertion of the glucose sensor.
  • Illicit drugs abuse.
  • Alcohol abuse.
  • Sickle cell disease, haemoglobinopathy, receiving red blood cell transfusion or erythropoietin within 3 months prior to time of enrollment.
  • Eating disorder including anorexia/bulimia.
  • Milk protein allergy.

Treatment and study plan

Advanced Hybrid Closed Loop from onset of type 1 diabetes in children

Device

The objective of this study is to evaluate glycemic control of users of the AHCL system MiniMed 780G with GS4 calibration-free sensor in children and adolescents with newly diagnosed T1D implemented directly upon T1D diagnosis in combination with continuous glucose monitoring system (CGMS) compared with those treated with MDI retrieved from historical data- in a single- arm open-label prospective observational study, assessed at 3 months. After the initial study period there will be a 3month extension phase of the study.

Primary outcomes

  1. CGMS metrics

    Time frame: 3 and 6 months (extension phase)

    CGMS metrics including Time in Range (70-180 mg/dl) during the 3 months' study period, i.e. from baseline to 3 months (90 days) extracted from the CGMS data from both the study group and children and adolescents in MDI- FGM/CGM group (historical data from age and sex matched children and adolescents followed in the same Diabetes Center). The same metrics will be evaluated in the extension phase of the study, namely at 6-months post initiation of the study.

  2. HbA1c

    Time frame: 3 months and 6 months (extension phase)

    HbA1c

Secondary outcomes

  1. Acceptance of AHCL

    Time frame: 3 months

    Assess the percentage of the study participants willing to continue their therapy with AHCL as shown by prescribing the 780G insulin pump after the 3 months' time of their participation to the study.

  2. TAR (Time Above Range) (>180mg/dl)

    Time frame: 3 months and 6 months (extension phase)

    Time Above Range (>180mg/dl) from baseline to 3 months (90 days) extracted from the CGMS data from both the study group and children and adolescents in MDI- FGM/CGM group (historical data from age and sex matched children and adolescents followed in the same Diabetes Center). The same metrics will be evaluated in the extension phase of the study, namely at 6-months post initiation of the study.

  3. TBR (Time Below Range) (<70mg/dl)

    Time frame: 3 and 6 months (extension phase)

    TBR (Time Below Range) during the 3 months' study period, i.e. from baseline to 3 months (90 days) extracted from the CGMS data from both the study group and children and adolescents in MDI- FGM/CGM group (historical data from age and sex matched children and adolescents followed in the same Diabetes Center). The same metrics will be evaluated in the extension phase of the study, namely at 6-months post initiation of the study.

  4. AHCL use

    Time frame: 3 and 6 months (extension phase)

    Advanced Hybrid Closed Loop use during the 3 months' study period, i.e. from baseline to 3 months (90 days) extracted from AHCL data. The same metric will be evaluated in the extension phase of the study, namely at 6-months post initiation of the study.

  5. Total daily insulin requirements

    Time frame: 3 and 6 months (extension phase)

    Total daily insulin requirements during the 3 months' study period, i.e. from baseline to 3 months (90 days) extracted from the CGMS data from both the study group and children and adolescents in MDI- FGM/CGM group (historical data from age and sex matched children and adolescents followed in the same Diabetes Center). The same metrics will be evaluated in the extension phase of the study, namely at 6-months post initiation of the study.

  6. Hypoglycemia Fear Survey for Children and Parents (HFS-C & P)

    Time frame: baseline, 3 months and 6 months (extension phase)

    QoL of the study participants before, 3 months and 6 months after initiation of the study, with the use of the questionnaire "Hypoglycemia Fear Survey for Children and Parents (HFS-C & P)"

  7. PedsQL 3.0 Diabetes Module [Child (8-12 years of age) and Parent-Proxy Report for Children (ages 8-12), Adolescent (13-18 years of age), where appropriate

    Time frame: baseline, 3 months and 6 months (extension phase)

    QoL of the study participants before, 3 months and 6 months after initiation of the study, with the use of questionnaire "PedsQL 3.0 Diabetes Module [Child (8-12 years of age) and Parent-Proxy Report for Children (ages 8-12), Adolescent (13-18 years of age), where appropriate

  8. Brief Illness Perception Questionnaire

    Time frame: baseline, 3 months and 6 months (extension phase)

    QoL of the study participants before, 3 months and 6 months after initiation of the study, with the use of questionnaire "Brief Illness Perception Questionnaire"

  9. Fasting c-peptide, ΒΜΙ-SDS from baseline to 3 and 6 months

    Time frame: baseline, 3 months and 6 months (extension phase)

    Assess the change in fasting c-peptide from baseline to 3 and 6 months

  10. ΒΜΙ-SDS

    Time frame: baseline, 3 months and 6 months (extension phase)

    Assess the change in ΒΜΙ-SDS from baseline to 3 and 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Kanaka- Gantenbein, Professor

CONTACT

[email protected]

00302132013244

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Collaborators

  • Aghia Sophia Children's Hospital of Athens

Registry information

Official study title

Assessing the Effect of Advanced Hybrid Closed Loop System, MiniMed 780G With GS4 Glucose Sensor in Newly Diagnosed Children and Adolescents With Type 1 Diabetes on Glycemic Control and Patient Reported Outcomes Compared to Standard Insulin Therapy Historical Data (AHCL in New Onset T1D Children Study): a Single Arm Open- Label Prospective Observational Study Protocol

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 9, 2025
Registry last updated
Apr 9, 2025

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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