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)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type I
• Intervention / Treatment: Device: Advanced Hybrid Closed Loop from onset of type 1 diabetes in children

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Christina Kanaka- Gantenbein, Professor; Phone Number: 00302132013244; Email: ckanaka@med.uoa.gr

Study Locations

• Greece
  • Athens, Greece, 11527
    • Recruiting
    • First Department of Pediatrics, National and Kapodistrian University of Athens, Medical School, "Aghia Sophia" Children's Hospital
    • Contact: Ioannis- Anargyros Vasilakis, PhD; Phone Number: 00302107467583; Email: vasilakisioan.pedendo@gmail.com
    • Contact: Christina Kanaka- Gantenbein, Professor
    • Contact: Ioannis- Anargyros Vasilakis, PhD
    • Contact: Eleni Angelopoulou
    • Contact: Sophia Sakka, Asst. Prof.
    • Contact: Alexandra Tsigkri
    • Contact: Ioanna Gkika
    • Contact: Ioanna Tokou
    • Contact: Vassia Chioti
    • Contact: Maria Michou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CGMS metrics	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.	3 and 6 months (extension phase)
HbA1c	HbA1c	3 months and 6 months (extension phase)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance of AHCL	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.	3 months
TAR (Time Above Range) (>180mg/dl)	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 months and 6 months (extension phase)
TBR (Time Below Range) (<70mg/dl)	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.	3 and 6 months (extension phase)
AHCL use	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.	3 and 6 months (extension phase)
Total daily insulin requirements	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.	3 and 6 months (extension phase)
Hypoglycemia Fear Survey for Children and Parents (HFS-C & P)	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)"	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	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	baseline, 3 months and 6 months (extension phase)
Brief Illness Perception Questionnaire	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"	baseline, 3 months and 6 months (extension phase)
Fasting c-peptide, ΒΜΙ-SDS from baseline to 3 and 6 months	Assess the change in fasting c-peptide from baseline to 3 and 6 months	baseline, 3 months and 6 months (extension phase)
ΒΜΙ-SDS	Assess the change in ΒΜΙ-SDS from baseline to 3 and 6 months	baseline, 3 months and 6 months (extension phase)

Collaborators and Investigators

• Sponsor: National and Kapodistrian University of Athens
• Collaborators: Aghia Sophia Children's Hospital of Athens

Publications and helpful links

General 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. 2024 Aug 1;47(8):1441-1448. doi: 10.2337/dc24-0360.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: type 1 diabetes; advanced hybrid closed loop; diabetes onset
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 6267/14.3.2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes