Menu
Recruiting 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)

— Observational Diabetes Mellitus, Type I

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Advanced Hybrid Closed Loop from onset of type 1 diabetes in children.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type I. Basic parameters: 7 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

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

Primary outcome measures

  • CGMS metrics [Time frame: 3 and 6 months (extension phase)]
  • HbA1c [Time frame: 3 months and 6 months (extension phase)]
Secondary outcome measures (10)
  • Acceptance of AHCL [Time frame: 3 months]
  • TAR (Time Above Range) (>180mg/dl) [Time frame: 3 months and 6 months (extension phase)]
  • TBR (Time Below Range) (<70mg/dl) [Time frame: 3 and 6 months (extension phase)]
  • AHCL use [Time frame: 3 and 6 months (extension phase)]
  • Total daily insulin requirements [Time frame: 3 and 6 months (extension phase)]
  • Hypoglycemia Fear Survey for Children and Parents (HFS-C & P) [Time frame: baseline, 3 months and 6 months (extension phase)]
  • 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)]
  • Brief Illness Perception Questionnaire [Time frame: baseline, 3 months and 6 months (extension phase)]
  • Fasting c-peptide, ΒΜΙ-SDS from baseline to 3 and 6 months [Time frame: baseline, 3 months and 6 months (extension phase)]
  • ΒΜΙ-SDS [Time frame: baseline, 3 months and 6 months (extension phase)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Greece · 1 center
  • First Department of Pediatrics, National and Kapodistrian University of Athens, Medical Sc — Athens

Publications

  • Ware J, Boughton CK, Allen JM, Wilinska ME, Hartnell S, Thankamony A, Randell T, Ghatak A, Besser REJ, Elleri D, Trevelyan N, Campbell FM, Sibayan J, Bailey R, Calhoun P, Dunseath G, Hovorka R; CLOuD Consortium. Effect of 48 Months of Closed-Loop Insulin Delivery on Residual C-Peptide Secretion and Glycemic Control in Newly Diagnosed Youth With Type 1 Diabetes: A Randomized Trial. Diabetes Care. 2 PMID 38924772
  • Michaels VR, Boucsein A, Watson AS, Frewen CM, Sanders OJ, Haszard JJ, Jones SD, Milford-Hughes PJ, de Bock MI, Wheeler BJ. Glucose and Psychosocial Outcomes 12 Months Following Transition from Multiple Daily Injections to Advanced Hybrid Closed Loop in Youth with Type 1 Diabetes and Suboptimal Glycemia. Diabetes Technol Ther. 2024 Jan;26(1):40-48. doi: 10.1089/dia.2023.0334. Epub 2023 Nov 7. PMID 37823890
  • Petrovski G, Al Khalaf F, Campbell J, Day E, Almajaly D, Hussain K, Pasha M, Umer F, Hamdan M, Khalifa A. Glycemic outcomes of Advanced Hybrid Closed Loop system in children and adolescents with Type 1 Diabetes, previously treated with Multiple Daily Injections (MiniMed 780G system in T1D individuals, previously treated with MDI). BMC Endocr Disord. 2022 Mar 29;22(1):80. doi: 10.1186/s12902-022-00 PMID 35351095
  • Boucsein A, Watson AS, Frewen CM, Sanders OJ, Haszard JJ, Jones SD, Milford-Hughes PJ, de Bock MI, Wheeler BJ. Impact of Advanced Hybrid Closed Loop on Youth With High-Risk Type 1 Diabetes Using Multiple Daily Injections. Diabetes Care. 2023 Mar 1;46(3):628-632. doi: 10.2337/dc22-1971. PMID 36689621

Identifiers

NCT: NCT06919029 · 6267/14.3.2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗