Clinical trial 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)
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus, Type I
Keywords: type 1 diabetes
advanced hybrid closed loop
diabetes onset
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
Collaborators: name: Aghia Sophia Children's Hospital of Athens
First posted: 2025-04-09
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is a single-center open-label, single arm, trial, comparing advanced hybrid closed-loop (AHCL) insulin delivery and standard insulin therapy with multiple daily injections (MDI) (historical data- control) over a period of 3 months in newly diagnosed type 1 diabetes children and adolescents hospitalized and followed at the Diabetes center of the First Department of Pediatrics of the Medical School of the National and Kapodistrian University of Athens, Athens, Greece. After the initial 3 months, there will be an extension phase of the study, for another 3 months (total 6 months).

A total of 30-35 individuals (aged 7-17 years) will be enrolled to reach 25-30 individuals who will complete the 3-months' study. The expected number of participants is based on the last 3 years data of our Diabetes Center, where the total number of newly diagnosed children/ adolescents with T1D (and those over 7 years of age) in our Center was as follows, in 2022: 56 (36), in 2023: 63 (47), in 2024.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Age range 7 to 17 years.
3. Literate in Greek or English.
4. Willing to wear study devices.
5. Willing to follow study-specific instructions.
6. Total daily insulin dose greater than 8.0 units over 1 week period
7. Willing and able (access to internet from home) to download information into the Medtronic CareLink software
8. 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.

Primary outcomes:
measure: CGMS metrics
timeFrame: 3 and 6 months (extension phase)
measure: HbA1c
timeFrame: 3 months and 6 months (extension phase)
Secondary outcomes:
measure: Acceptance of AHCL
timeFrame: 3 months
measure: TAR (Time Above Range) (>180mg/dl)
timeFrame: 3 months and 6 months (extension phase)
measure: TBR (Time Below Range) (<70mg/dl)
timeFrame: 3 and 6 months (extension phase)
measure: AHCL use
timeFrame: 3 and 6 months (extension phase)
measure: Total daily insulin requirements
timeFrame: 3 and 6 months (extension phase)
measure: Hypoglycemia Fear Survey for Children and Parents (HFS-C & P)
timeFrame: baseline, 3 months and 6 months (extension phase)
measure: 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
timeFrame: baseline, 3 months and 6 months (extension phase)
measure: Brief Illness Perception Questionnaire
timeFrame: baseline, 3 months and 6 months (extension phase)
measure: Fasting c-peptide, ΒΜΙ-SDS from baseline to 3 and 6 months
timeFrame: baseline, 3 months and 6 months (extension phase)
measure: ΒΜΙ-SDS
timeFrame: baseline, 3 months and 6 months (extension phase)
Other outcomes:
Locations:
city: Athens
country: Greece
facility: First Department of Pediatrics, National and Kapodistrian University of Athens, Medical School, "Aghia Sophia" Children's Hospital
Study officials:
References:
citation: 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. 2024 Aug 1;47(8):1441-1448. doi: 10.2337/dc24-0360.
citation: 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.
citation: 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/s12902-022-00996-7.
citation: 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.