The Artificial Pancreas in Very Young Children With T1D (KidsAP02)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03784027|
Recruitment Status : Active, not recruiting
First Posted : December 21, 2018
Last Update Posted : November 12, 2020
The suggested clinical trial is part of the KidsAP project funded by the European Commission's Horizon 2020 Framework Programme with additional funding by JDRF. The project evaluates the use of the Artificial Pancreas (or closed loop system) in very young children with type 1 diabetes (T1D) aged 1 to 7 years. The suggested trial is an outcome study to determine whether 24/7 automated closed loop glucose control will improve glucose control as measured by time in range compared to sensor augmented pump therapy. In the extension phase, the purpose is to evaluate the effect of long-term home use of 24/7 automated hybrid closed loop insulin delivery on glucose control (UK sites only).
The study adopts an open-label, multi-centre, multi-national, randomised, two period, cross-over design study, contrasting a 4 month period during which glucose levels will be controlled either by a closed loop system (intervention group) or by sensor augmented pump therapy (control group).
The two intervention periods will last 4 months each with a 1 to 4 weeks washout period in between. The order of the two interventions will be random. A total of up to 80 young children aged 1 to 7 years with T1D on insulin pump therapy (aiming for 72 randomised subjects) will be recruited through paediatric outpatient diabetes clinics of the investigation centres.
Prior to the use of study devices, participants and parents/guardians will receive appropriate training by the research team on the safe use of the study pump and continuous glucose monitoring device, and the hybrid closed loop insulin delivery system. Carers at nursery or school may also receive training by the study team if required.
During the closed loop study arm, subjects and parents/guardians will use the closed loop system for 4 months under free-living conditions in their home and nursery/school environment without remote monitoring or supervision by research staff.
During the control study arm, subjects and parents/guardians will use sensor augmented pump therapy for 4 months under free-living conditions in their home and nursery/school environment. All subjects will have regular contact with the study team during the home study phase including 24/7 telephone support.
The primary endpoint is time spent in target range, between 3.9 and 10.0 mmol/l as recorded by CGM. Secondary outcomes are the time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Safety evaluation comprises assessment of the frequency and severity of hypoglycaemic episodes and diabetic ketoacidosis (DKA).
During the extension phase, participants will have follow-up contacts every 3 months.
The primary endpoint is time spent in target range, between 3.9 and 10.0 mmol/l as recorded by CGM, over 18 months from the end of the primary phase, as compared to sensor augmented pump therapy during the primary phase. Secondary outcomes as well as safety and utility will be assessed as per primary phase.
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Device: CamAPS FX Other: Sensor augmented therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||
Device: CamAPS FX
The automated closed loop system (CamAPS FX) will consist of:
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Multi-centre, Multi-national, Randomised, 2-period Crossover Study to Assess the Efficacy, Safety and Utility of Closed Loop Insulin Delivery in Comparison With Sensor Augmented Pump Therapy Over 4 Months in Children With Type 1 Diabetes Aged 1 to 7 Years in the Home Setting With Extension to Evaluate the Efficacy of Home Use of Closed Loop Insulin Delivery.|
|Actual Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||December 1, 2021|
Experimental: Automated closed loop insulin delivery (intervention arm)
Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 4 months.
Intervention: Device: CamAPS FX
Device: CamAPS FX
CamAPS FX closed loop system comprises:
Active Comparator: Sensor augmented pump therapy (control arm)
Sensor augmented pump therapy over 4 months
Other: Sensor augmented therapy
Study insulin pump and study CGM.
- Time in target (3.9 to 10.0 mmol/l) (70 to 180 mg/dl) [ Time Frame: 4-month home stay ]Between group difference in time spent with sensor glucose levels between 3.9 to 10.0 mmol/l (70 to 180 mg/dl) during the 4 months intervention period.
- Time spent above target glucose (10.0 mmol/l) (180 mg/dl) [ Time Frame: 4-month home stay ]Percentage of time spent with sensor glucose readings above target glucose (10.0mmol/l) (180mg/dl)
- HbA1c [ Time Frame: 4-month home stay ]
- Average glucose [ Time Frame: 4-month home stay ]Average of sensor glucose levels
- Time spent below target glucose (3.0 mmol/l) (70 mg/dl) [ Time Frame: 4-month home stay ]Percentage of time spent with sensor glucose readings below target glucose (3.9mmol/l)(70mg/dl)
- Standard deviation [ Time Frame: 4-month home stay ]Standard deviation of sensor glucose levels
- Coefficient of variation of glucose levels [ Time Frame: 4-month home stay ]Coefficient of variation of sensor glucose levels
- Time with glucose levels <3.0 mmol/l (54 mg/dl) [ Time Frame: 4-month home stay ]Percentage of time spent with glucose levels < 3.5mmol/l (63 mg/dl)
- Time with glucose levels in significant hyperglycaemia (glucose levels > 16.7 mmol/l) (300 mg/dl) [ Time Frame: 4-month home stay ]Percentage of time spent with glucose levels in significant hyperglycaemia (glucose levels > 16.7mmol/l) (300mg/dl)
- AUC of glucose below 3.5 mmol/l (63 mg/dl) [ Time Frame: 4-month home stay ]Area under the curve of sensor glucose readings below 3.5mmol/l (63mg/dl)
- BMI SDS [ Time Frame: 4-month home stay ]
- Total, basal, and bolus insulin dose [ Time Frame: 4-month home stay ]
- Number of episodes of severe hypoglycaemia [ Time Frame: 4-month home stay ]Safety evaluation
- Number of subjects experiencing severe hypoglycaemia [ Time Frame: 4-month home stay ]Safety evaluation
- Frequency of diabetic ketoacidosis [ Time Frame: 4-month home stay ]Safety evaluation
- Frequency and nature of other adverse events or serious adverse events [ Time Frame: 4-month home stay ]Safety evaluation
- Percentage of time of closed-loop operation [ Time Frame: 4-month home stay ]Utility evaluation
- Percentage of time of CGM availability [ Time Frame: 4-month home stay ]Utility evaluation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03784027
|Medical University of Graz Department of Pediatrics and Adolescent Medicine|
|Graz, Austria, A-8036|
|Medical University of Innsbruck Department of Pediatrics I|
|Innsbruck, Austria, A-6020|
|Medical University of Vienna Department of Pediatrics|
|Wien, Austria, A-1090|
|University of Leipzig Division for Paediatric Diabetology|
|Leipzig, Germany, D-04103|
|Clinique Pédiatrique de Luxembourg Centre Hospitalier de Luxembourg|
|Luxembourg, Luxembourg, L-1210|
|University Department of Paediatrics|
|Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ|
|Wellcome Trust-MRC Institute of Metabolic Science University of Cambridge|
|Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ|
|St James's University Hospital|
|Leeds, United Kingdom, LS9 7TF|
|Study Director:||Roman Hovorka||Wellcome Trust-MRC Institute of Metabolic Science University of Cambridge|