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O estudo clínico NCT03671915 (DBL4K) para Closed Loop, Diabetes mellitus tipo 1, Young Children (6 to 12 Years Old ) está concluído. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Diabeloop for Kids (DBL4K) 21 Randomizado Estudo cruzado Estudo aberto Remoto
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O estudo clínico NCT03671915 (DBL4K) foi um estudo intervencionista para Closed Loop, Diabetes mellitus tipo 1, Young Children (6 to 12 Years Old ). Seu status atual é: concluído. O estudo começou em 6 de maio de 2019 e incluiu 21 participantes. Coordenado por Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète e foi concluído em 23 de dezembro de 2019. Essas informações foram atualizadas no ClinicalTrials.gov em 6 de março de 2020.
Resumo
An open-label, three-center, randomized, two-session, 4 days inpatient and 6-week follow-up home study phase, crossover study comparing Diabeloop closed-loop (CL) system and sensor-augmented pump (SAP) therapy.
The follow-up home study phase will be done only in French centers for a sub study. During this session, patient wearing the closed-loop system will benefit of a 24h/24, 7 d/7, remote monitoring follow-up by ...
Mostrar maisTítulo oficial
An Open-label, Three-center, Randomized, Two-session, Crossover Study, to Assess 4 Days Inpatient, and 6-week Follow-up Home Study Phase Under Remote Monitoring at Only French Centers, the Efficacy and the Safety of the Diabeloop Closed-loop Glucose Control Compared With Sensor-augmented Pump Therapy, in Young Children With Type 1 Diabetes.
Condições médicas
Closed LoopDiabetes mellitus tipo 1Young Children (6 to 12 Years Old )Publicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:Outros IDs do estudo
- DBL4K
- 2018-A02078-47
Número NCT
Data de início (real)
2019-05-06
Última atualização postada
2020-03-06
Data de conclusão (estimada)
2019-12-23
Inscrição (estimada)
21
Tipo de estudo
Intervencionista
FASE
N/A
Status
Concluído
Palavras-chave
artificial pancreas
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Estudo cruzado
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
Comparador ativoUsual System (Open-loop) In open loop: sensor-augmented pump (SAP) therapy using standard insulin pump setting combined with the six-generation glucose sensor (Dexcom G6). | Monitoramento contínuo de glicose collection of glucose data External Insulin Pump Insulin delivery |
ExperimentalDIABELOOP System (Closed-loop) In the closed loop: Diabeloop software (an MPC-based glucose control algorithm) running on handset associated with the six-generation glucose sensor (Dexcom G6) and Kaleïdo insulin pump.
A remote monitoring system managed by specialized nurse on behalf diabetologist, is provided in closed-loop session. | Monitoramento contínuo de glicose collection of glucose data External Insulin Pump Insulin delivery Diabeloop Software (Model predictive control) Diabeloop software embeds a regulation algorithm to automatically regulate the patient's glycaemia. It takes as input glycaemia value received every 5 minutes from the CGM and patient inputs related to meals and physical activities and it calculates the amount of insulin to be delivered. It sends this information to the pump that automatically delivers this quantity. Remote monitoring (Telemedicine) Remote follow up by care health providers team |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
The time spent of the glucose level drop in below 70 mg/dl over the 72-h, as recorded by continuous subcutaneous glucose monitoring (CGM). | Measurement of glucose by CGM | 72 hours |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Sensor mean glucose | Sensor mean glucose over the 72-h, in the overnight (defined as 23:00 to 07:00) and during the home study phase for the French centers, in closed-loop and open-loop session | 72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase) |
Coefficient of variation (SD/Mean %) | 72 hours | |
Standard deviation (SD mg/dl) of the glucose rate of change as recorded by the CGM | Measurement of glucose by CGM | 72 hours |
Low Blood Glucose Index (LBGI) and high blood glucose Index (HBGI) | Measurement of glucose by CGM | 72 hours and 6 weeks (home study phase) |
Percentage of sensor time in glucose range 70-140 mg/dl | Measurement of glucose by CGM | 72 hours and 6 weeks (home study phase) |
Percentage time in glucose levels in the widened target range 70-180 mg/dl | Measurement of glucose by CGM | 72 hours and 6 weeks (home study phase) |
Fasting blood glucose, mg/dl (mmol/L) | 72 hours and 6 weeks | |
Sensor time spent in glucose levels below 54 mg/dl, 60 mg/dl | Measurement of glucose by CGM | 72 hours |
Sensor time spent in glucose levels below 54 mg/dl, 60 mg/dl, and 70 mg/dl | Measurement of glucose by CGM | 72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase) |
Number of severe Hyperglycemic events as well as the number of subjects experiencing sever hypoglycemia | Measurement of glucose by CGM | 72 hours and 6 weeks (home study phase) |
Time spent in glucose levels above 180 mg/dl, 250 mg/dl, 300 mg/dl | Measurement of glucose by CGM | 72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase) |
Severe Diabetic Ketoacidosis (DKA) events | Subjects will be asked to measure blood urine ketone levels on waking in the morning if their finger-stick glucose is above 200 mg/l, as part of the safety evaluation for hyperglycemia. | 72 hours and 6 weeks (home study phase) |
Percentage of time closed-loop active | 72 hours and 6 weeks (home study phase) | |
Total daily dose of insulin | Total basal and bolus by 24h | 72 hours and 6 weeks (home study phase) |
Subject's perception in terms of life-style change, satisfaction and diabetes management | Subject's perception in terms of life-style change, satisfaction and diabetes management as evaluated by PedsQL, DTQ, DTSQ and AP acceptance questionnaire. | 72 hours and 6 weeks (home study phase) |
Critérios de elegibilidade
Idades elegíveis
Criança
Idade mínima
6 Years
Sexos elegíveis
Todos
- Prepubescent children (Gender: both) aged between 6 to 12 years old (Tanner stage 1) at time of screening
- Type 1 diabetes as defined by WHO for at least 1 year or confirmed C peptide negative
- An insulin pump user for at least 3 months.
- Subject having a Glycosylated hemoglobin (HbA1c) blood value < 9% at time of screening visit-based on analysis from local laboratory within 3 months.
- Subject having a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.
- Subject and his parent/guardian willing to spend 3-overnight in hospital.
- Subject willing to wear the system continuously throughout the study
- Subjects and his parent/guardian must be able to speak and be literate in French or Flemish as verified by the investigator
- Children who are in pubertal stage
- Subject has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening: - Medical assistance (i.e. Paramedics, Emergency Room (ER) or Hospitalization) - Coma - Seizures
- Subject having sever DKA in the 6 months prior to screening visit.
- Known or suspected allergy against insulin
- Any other physical or psychological disease, or medication likely to interfere with the conduct of the study and interpretation of the study results as judged by the investigator.
- Subject is unable to tolerate tape adhesive around the sensor or pump placements
- Subject has a cardiovascular condition which the investigator determines should exclude the subject, i.e. ventricular rhythm disturbance, hypertrophic cardiomyopathy
- Subject having took any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the study.
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteSem dados de contato.
3 Locais do estudo em 2 países
University Hospitals Leuven, Leuven, 3000, Belgium
Necker Enfants Malades Hospital, Paris, 75015, France
Toulouse University Hospital Center, Toulouse, 31059, France