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

12. juni 2018 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

24

Fase

  • Fase 2

Kontakter og plasseringer

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Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

7 år til 12 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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 €

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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).
Enhet: 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
Enhet: 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
Eksperimentell: 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).
Enhet: 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
Enhet: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Time spent with blood glucose <70 mg/dl
Tidsramme: from 22:00 to 08:00, over two consecutive nights
from 22:00 to 08:00, over two consecutive nights

Sekundære resultatmål

Resultatmål
Tidsramme
Percent time spent with blood glucose <70mg/dl
Tidsramme: over two consecutive days (48h)
over two consecutive days (48h)
Percent time spent with blood glucose level in 70-180 mg/dl range
Tidsramme: 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
Tidsramme: 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
Tidsramme: over two consecutive days (48h)
over two consecutive days (48h)
Mean blood glucose level
Tidsramme: from 22:00 to 08:00, over two consecutive nights
from 22:00 to 08:00, over two consecutive nights
Mean blood glucose level
Tidsramme: 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
Tidsramme: 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
Tidsramme: during 65 hours of each investigational session
during 65 hours of each investigational session
Score of the Artificial Pancreas Acceptance Questionnaire
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

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Sponsor

University Hospital, Montpellier

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

16. juni 2015

Primær fullføring (Faktiske)

1. desember 2016

Studiet fullført (Faktiske)

1. desember 2016

Datoer for studieregistrering

Først innsendt

8. juli 2015

Først innsendt som oppfylte QC-kriteriene

23. juli 2015

Først lagt ut (Anslag)

28. juli 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. juni 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. juni 2018

Sist bekreftet

1. juli 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 9525 (Annen identifikator: CTEP)

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