N/A
Completed N=74
The Artificial Pancreas in Very Young Children With T1D
Source: ClinicalTrials.gov NCT03784027 ↗Enrolled (actual)
74
Serious AEs
1.4%
Results posted
Mar 2025
Primary outcomePrimary: Time in Target (3.9 to 10.0 mmol/l) (70 to 180 mg/dl) — 71.6; 62.9 Percent of time spent in target range — p=<0.001
Summary
The suggested clinical trial is part of the KidsAP project funded by the European Commission's Horizon 2020 Framework Programme and JDRF. It evaluates the use of the Artificial Pancreas (closed loop system) in very young children with type 1 diabetes (T1D) aged 1-7 years. This outcome study aims to determine whether 24/7 automated closed loop glucose control improves time in range compared to sensor augmented pump therapy. An extension phase will evaluate the effect of long-term home use of the 24/7 automated hybrid closed loop insulin delivery system on glucose control (UK sites only).
The study employs an open-label, multi-centre, multi-national, randomized, two-period, crossover design. Participants undergo a 2-4 week run-in period, followed by two 16-week treatment periods (one for each therapy) separated by a 1-4 week washout. The order of treatments is randomized. Up to 80 young children (with a target of 72 randomized subjects) on insulin pump therapy will be recruited from paediatric outpatient diabetes clinics.
Before using the study devices, participants and their parents/guardians receive training on the safe use of the study pump, continuous glucose monitoring (CGM) device, and hybrid closed loop system. Nursery or school carers may also be trained if needed. During the closed loop arm, subjects use the system for 16 weeks under free-living conditions at home and in nursery/school without remote monitoring. In the control arm, subjects use sensor augmented pump therapy for 16 weeks under similar conditions, with regular contact and 24/7 telephone support from the study team.
The primary endpoint is the time spent in the target glucose range (3.9-10.0 mmol/l) as recorded by CGM. Secondary outcomes include the time spent with glucose levels above and below target and other CGM metrics. Safety assessments include the frequency and severity of hypoglycaemic episodes and diabetic ketoacidosis (DKA). In the extension phase, participants have follow-up contacts every 3 months, with the primary endpoint measured over 18 months from the end of the primary phase and compared to sensor augmented pump therapy during that phase. Secondary outcomes, safety, and utility will be assessed similarly.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time in Target (3.9 to 10.0 mmol/l) (70 to 180 mg/dl) |
71.6; 62.9 | <0.001 sig |
| SECONDARY Key Endpoint: Time Spent Above Target Glucose (10.0 mmol/l) (180 mg/dl) |
22.9; 31.7 | <0.001 sig |
| SECONDARY Key Endpoint: HbA1c |
49.0; 52.8 | <0.001 sig |
| SECONDARY Key Endpoint: Mean Sensor Glucose |
145.8; 158.1 | <0.001 sig |
| SECONDARY Key Endpoint: Time Spent Below Target Glucose (3.9 mmol/l) (70 mg/dl) |
4.9; 4.5 | 0.74 |
| SECONDARY Standard Deviation |
58.6; 64.2 | — |
| SECONDARY Coefficient of Variation (Percentage) of Glucose Levels |
41; 41 | — |
| SECONDARY Time With Glucose Levels <3.0 mmol/l (54 mg/dl) |
1.0; 0.9 | — |
| SECONDARY Time With Glucose Levels in Significant Hyperglycaemia (Glucose Levels > 16.7 mmol/l) (300 mg/dl) |
2.0; 3.1 | — |
| SECONDARY AUC of Glucose Below 3.5 mmol/l (63 mg/dl) |
0.1; 0.1 | — |
| SECONDARY BMI SDS |
71; 70 | 0.75 |
| SECONDARY Total, Basal, and Bolus Insulin Dose |
16.9; 17.6; 8.0; 5.7; 8.6; 11.0 | — |
| SECONDARY Number of Episodes of Severe Hypoglycaemia |
1; 0 | — |
| SECONDARY Number of Subjects Experiencing Severe Hypoglycaemia |
1; 0 | — |
| SECONDARY Frequency of Diabetic Ketoacidosis |
0; 0 | — |
| SECONDARY Frequency and Nature of Other Adverse Events |
53; 56; 15; 12; 5; 6 | — |
| SECONDARY Percentage of Time of CGM Availability |
99; 99 | — |
| SECONDARY Percentage of Time of Closed-loop Operation |
95 | — |
| SECONDARY Frequency and Nature of Other Serious Adverse Events |
0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Age between 1 and 7 years (inclusive) (Luxembourg and Austria)
- Age between 2 and 7 years (inclusive) (Germany and UK)
- Type 1 diabetes as defined by WHO for at least 6 months [WHO definition: 'The aetiological type named type 1 encompasses the majority of cases which are primarily due to beta-cell destruction, and are prone to ketoacidosis. Type 1 includes those cases attributable to an autoimmune process, as well as those with beta-cell destruction for which neither an aetiology nor a pathogenesis is known (idiopathic). It does not include those forms of beta-cell destruction or failure to which specific causes can be assigned (e.g. cystic fibrosis, mitochondrial defects, etc.).']
- Insulin pump user (with or without continuous glucose monitoring or flash glucose monitoring system) for at least 3 months, with subject/carer good knowledge of insulin self-adjustment as judged by the investigator
- On sensor-augmented pump as standard clinical care (extension phase only)
- Treated with rapid or ultra-rapid acting insulin analogue
- Subject/carer is willing to perform regular finger-prick blood glucose monitoring, with at least 2 blood glucose measurements taken every day
- Screening HbA1c ≤ 11% (97mmol/mol) on analysis from local laboratory
- Willing to wear glucose sensor
- Willing to wear closed loop system 24/7 during intervention arm
- The subject/carer is willing to follow study specific instructions
- The subject/carer is willing to upload pump and CGM data at regular intervals
Exclusion Criteria
- Physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
- Untreated coeliac disease or thyroid disease based on local investigations prior to study enrolment
- Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids
- Use of closed loop insulin delivery within the past 2 months
- Known or suspected allergy to insulin
- Carer's lack of reliable telephone facility for contact
- Subject/carer's severe visual impairment
- Subject/carer's severe hearing impairment
- Medically documented allergy towards the adhesive (glue) of plasters or subject is unable to tolerate tape adhesive in the area of sensor placement
- Serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) located in parts of the body which could potentially be used for localisation of the glucose sensor)
- Sickle cell disease, haemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
- Plan to receive red blood cell transfusion or erythropoietin over the course of study participation
- Subject/carer not proficient in English (UK, Germany, Austria, Luxembourg) or German (Germany, Austria, Luxembourg) or French (Luxembourg)
Additional exclusion criteria - Germany only
- Known microvascular diabetes complications (retinopathy, renal disease, neuropathy)
- Eating disorders
- Psychiatric diseases of the parents that would possibly interfere with the ability to comply to study procedures
- Major needle phobia that would complicate to wear pump catheter and sensor
- Congenital malformations that would interfere with diabetes treatment (e.g. congenital heart malformations, lung diseases, renal malformations)
- Growth hormone deficiency
- Combined Hypopituitarism
- Down Syndrome (high risk for comorbidity with coeliac disease, autoimmune thyroiditis)
- Cancer under treatment
- Current participation in other interventional clinical trials
Data sourced from ClinicalTrials.gov (NCT03784027). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.