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)

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• CGMS metrics [Срок оценки: 3 and 6 months (extension phase)]
• HbA1c [Срок оценки: 3 months and 6 months (extension phase)]

Вторичные конечные точки (10)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Греция · 1 центр

• First Department of Pediatrics, National and Kapodistrian University of Athens, Medical Sc — Athens

Публикации

• 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

Идентификаторы

NCT: NCT06919029 · 6267/14.3.2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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