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Comparison of an Artificial Pancreas Versus Threshold Low Glucose Suspend in Type 1 Diabetic Children (SHAN)

12 giugno 2018 aggiornato da: University Hospital, Montpellier

Assessment of the Efficacy on the Reduction of Nocturnal Hypoglycemia in Children With Type 1 Diabetes of a Closed-loop Insulin Therapy (Artificial Pancreas) Compared to Insulin Pump Therapy Combined With Continuous Glucose Monitoring With Threshold Low Glucose Suspend of Infusion in Home-like Conditions

The objective of this study is to assess the efficacy of an Artificial Pancreas system which includes a Control-To-Range algorithm, versus standard Insulin Pump Therapy with Threshold Low glucose Suspend feature. 24 Children aged from 7 to 12 will be recruted in 4 clinical centres. After a 2 week run-in period, they will attend two investigational sessions of 65 hours in home-like settings. During each session, the CTR algorithm or the TLGS feature will be activated, depending on the randomization. The main endpoint is the time spent below 70mg/dL between 22:00 and 07:00.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The study is an open randomized control trial preceded by a run-in period and follows a cross-over design.After inclusion, the therapy will be moved to sensor augmented pump therapy with a dedicated training to continuous glucose monitoring using study system (study CGM). During 2 to 3 weeks, the patient will use his/her usual insulin pump and the study CGM (run-in period). At the end of this period, the patient and the relative will be admitted in a parents'house or hotel/resort nearby the hospital for 65 hours to undergo the first interventional session. Admission will be at 17:00 Day 1. The investigator will connect wirelessly the study pump and CGM to the study platform DiAs and remote monitoring will be activated. Until 08:00 Day 2, insulin delivery will be managed in open-loop mode, i.e. insulin doses will be decided according to capillary glucose measurements. From 08:00 Day 2, one algorithm will be activated according to the randomization order, i.e. either the threshold low glucose suspend (TLGS) algorithm (threshold will be set at 70 mg/dl) or the closed-loop algorithm. Insulin delivery will then be managed in open-loop mode with activated TLGS or by the closed-loop algorithm until 08:00 Day 4. In both cases, meals will be of free content and taken around 09:00, 13:00, 17:00 and 20:00. Meal insulin doses will be managed according to pre-meal glucose level and CHO meal content in open-loop mode with TLGS, or according to DiAs bolus calculator suggestion in closed-loop mode. Patient and relative will be encouraged to move in parents'house or hotel/resort and surroundings between meals. The algorithm will be inactivated at 08:00 Day 4. The study pump will be removed and replaced by patient's usual pump. The patient and the relative will be released at 10:00 after breakfast. Study CGM will still be used at home for 2 to 4 weeks until the second interventional session. This session will be similar to the first one but the alternative algorithm will be activated. Patient will come back to pre-study insulin therapy from 08:00 Day 4 and be released at 10:00 when second session is completed.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

24

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Francia
      • Angers, Francia, 49000
        • CHU d'Angers
      • Montpellier, Francia, 34985
        • CHU Montpellier - Hôpital Lapeyronie
      • Paris, Francia, 75019
        • AP-HP, Hôpital Robert Debré
      • Tours, Francia, 37000
        • CHU de Tours, Hôpital Clocheville

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 7 anni a 12 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Age from 7 to 12
  2. Puberty status at Prader 1
  3. Diabetes diagnosed according to WHO criteria since more than 1 year
  4. Fasting plasma C-peptide level <0.2 ng/ml for a fasting blood glucose level < 180 mg/dl
  5. At least one positiveness for plasma antibodies against pancreatic islets: IAA, IA2, GAD, ICA or ZnT8, since diagnosis of diabetes
  6. Treatment of diabetes by insulin pump since more than 6 months
  7. HbA1c level below 8.5%
  8. Trained in carbohydrate counting
  9. Lack of any associated disease or therapy (except insulin) affecting glucose metabolism
  10. Willingness to follow all study procedures
  11. Informed consent signed by patient and parent or legally responsible party
  12. Patient must be affiliated or beneficiary of a social medical insurance

Exclusion Criteria:

  1. Unwillingness of one parent or the legally responsible party to be present during all study procedures
  2. Expected use of acetaminophen-containing drugs
  3. Any disease or therapy (except insulin) affecting glucose metabolism during previous month
  4. Impaired cognitive or psychological abilities which may result in defective adherence to study procedures
  5. Active enrollment in another clinical trial or participation in a study within 30 days or participation in previous studies resulting in a cumulated annual income which would exceed 4500 €

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Control-to-Range algorithm and Threshold Low Glucose Suspend

On this arm, patients will realize two investigational sessions:

  • the first with Control-to-Range algorithm (CTR),
  • the second with Threshold Low Glucose Suspend (TLGS).
Dispositivo: Insulin therapy (aspart, lispro ou glulisine) with Control-to-Range algorithm
The insuline used is usual patient insuline. There is no specific insulin for this protocol
Dispositivo: Insulin therapy ((aspart, lispro ou glulisine) withThreshold Low Glucose Suspend
The insuline used is usual patient insuline. There is no specific insulin for this protocol
Sperimentale: Threshold Low Glucose Suspend and Control-to-Range algorithm

On this arm, patients will realize two investigational sessions:

  • the first with Threshold Low Glucose Suspend (TLGS),
  • the second with Control-to-Range algorithm (CTR).
Dispositivo: Insulin therapy (aspart, lispro ou glulisine) with Control-to-Range algorithm
The insuline used is usual patient insuline. There is no specific insulin for this protocol
Dispositivo: Insulin therapy ((aspart, lispro ou glulisine) withThreshold Low Glucose Suspend
The insuline used is usual patient insuline. There is no specific insulin for this protocol

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Time spent with blood glucose <70 mg/dl
Lasso di tempo: from 22:00 to 08:00, over two consecutive nights
from 22:00 to 08:00, over two consecutive nights

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Percent time spent with blood glucose <70mg/dl
Lasso di tempo: over two consecutive days (48h)
over two consecutive days (48h)
Percent time spent with blood glucose level in 70-180 mg/dl range
Lasso di tempo: from 22:00 to 08:00 over two consecutive nights
from 22:00 to 08:00 over two consecutive nights
Percent time spent with blood glucose level in 80-150 mg/dl range
Lasso di tempo: from 22:00 to 08:00 over two consecutive nights
from 22:00 to 08:00 over two consecutive nights
Percent time spent with blood glucose level in 70-180 mg/dl range
Lasso di tempo: over two consecutive days (48h)
over two consecutive days (48h)
Mean blood glucose level
Lasso di tempo: from 22:00 to 08:00, over two consecutive nights
from 22:00 to 08:00, over two consecutive nights
Mean blood glucose level
Lasso di tempo: over two consecutive days (48h)
over two consecutive days (48h)
Number of needed interventions by the patients, the parents, and by the investigational team, to treat hypoglycemia
Lasso di tempo: during 65 hours of each investigational session
during 65 hours of each investigational session
Number of needed interventions by the patients, the parents, and by the investigational team, to fix issues related to the functioning of the insulin delivery system
Lasso di tempo: during 65 hours of each investigational session
during 65 hours of each investigational session
Score of the Artificial Pancreas Acceptance Questionnaire
Lasso di tempo: at time of inclusion (at Visit 2) and 5 to 6 weeks after inclusion (i.e at Visit 4)
at time of inclusion (at Visit 2) and 5 to 6 weeks after inclusion (i.e at Visit 4)
Score of the Hypo Fear Survey
Lasso di tempo: at time of inclusion (at Visit 2) and 5 to 6 weeks after inclusion (i.e at Visit 4)
at time of inclusion (at Visit 2) and 5 to 6 weeks after inclusion (i.e at Visit 4)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University Hospital, Montpellier

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

16 giugno 2015

Completamento primario (Effettivo)

1 dicembre 2016

Completamento dello studio (Effettivo)

1 dicembre 2016

Date di iscrizione allo studio

Primo inviato

8 luglio 2015

Primo inviato che soddisfa i criteri di controllo qualità

23 luglio 2015

Primo Inserito (Stima)

28 luglio 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 giugno 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 giugno 2018

Ultimo verificato

1 luglio 2015

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 9525 (Altro identificatore: CTEP)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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