Diabetes Mellitus, Type INCT06919029
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)
An observational study of Diabetes Mellitus, Type I, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Diabetes Mellitus, Type I
- What is being tested?
- Advanced Hybrid Closed Loop from onset of type 1 diabetes in children
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- Apr 2025to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
First Department of Pediatrics, National and Kapodistrian University of Athens, Medical School, "Aghia Sophia" Children's Hospital
Athens, 11527
Ioannis- Anargyros Vasilakis, PhD, 00302107467583, vasilakisioan.pedendo@gmail.com
Christina Kanaka- Gantenbein, Professor
About this 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
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.
- Conditions
- Diabetes Mellitus, Type I
- Being tested
- Advanced Hybrid Closed Loop from onset of type 1 diabetes in children
- Keywords
- type 1 diabetes, advanced hybrid closed loop, diabetes onset
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced Hybrid Closed Loop from onset of type 1 diabetes in childrenDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 and 6 months (extension phase)
HbA1c
HbA1c
Measured: 3 months and 6 months (extension phase)
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)"
Measured: 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
Measured: 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"
Measured: 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
Measured: baseline, 3 months and 6 months (extension phase)
ΒΜΙ-SDS
Assess the change in ΒΜΙ-SDS from baseline to 3 and 6 months
Measured: baseline, 3 months and 6 months (extension phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type IStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Aghia Sophia Children's Hospital of Athens
- Responsible party
- Principal investigator, Christina Kanaka-Gantenbein, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919029
- Sponsor's protocol ID
- 6267/14.3.2025
- Status last verified
- Apr 2025
- First submitted
- 2 Apr 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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.
PubMed 38924772Michaels 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.
PubMed 37823890Petrovski 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.
PubMed 35351095Boucsein 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.
PubMed 36689621
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06919029
- Acronym / sponsor ID
- 6267/14.3.2025
- Conditions
- Diabetes Mellitus, Type I
- Keywords
- type 1 diabetes, advanced hybrid closed loop, diabetes onset
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Collaborators
- Aghia Sophia Children's Hospital of Athens
- Study start
- Apr 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced Hybrid Closed Loop from onset of type 1 diabetes in childrenThe 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. | Device | – |
Primary outcome
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.
HbA1c
Time frame: 3 months and 6 months (extension phase)
HbA1c
10 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Background: PubMed 38924772Ware 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.
- Background: PubMed 37823890Michaels 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.
- Background: PubMed 35351095Petrovski 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.
- Background: PubMed 36689621Boucsein 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type I, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Kanaka- Gantenbein, Professor (00302132013244, ckanaka@med.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CGMS metrics (time frame: 3 and 6 months (extension phase)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06919029, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.