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Closing the Loop in Youth With Type 1 Diabetes in the Home Setting

22. september 2013 opdateret af: Dr Roman Hovorka, University of Cambridge

An Open-label, Single-centre, Randomised, 2-period Cross-over Study to Assess the Efficacy, Safety and Utility of Real-time Continuous Subcutaneous Glucose Monitoring Combined With Overnight Closed-loop Glucose Control in the Home Setting in Comparison With Real-time Continuous Subcutaneous Glucose Monitoring Alone in Adolescents With Type 1 Diabetes on Subcutaneous Insulin Infusion Pump Therapy.

Type 1 diabetes (T1D) is one of the most common chronic childhood diseases requiring life-long insulin therapy. Children and adolescents with T1D need regular insulin injections or the continuous insulin delivery using an insulin pump in order to keep blood glucose levels normal. The investigators know that keeping blood sugars in the normal range will help prevent long-term diabetes-related complications involving the eyes, kidneys and heart. However, achieving treatment goals can be very difficult as the tighter the investigators try to control blood glucose levels, the greater the risk to develop symptoms and signs of low glucose levels (hypoglycaemia). This is a particular problem at night and one solution is to develop a system whereby the amount of insulin injected is controlled by a computer and is very closely matched to the blood sugar levels on a continuous basis. This can be achieved by what is known as a "closed-loop system" where a small glucose sensor placed under the skin communicates with a computer containing an algorithm that drives an insulin pump. The investigators have been testing such a system in Cambridge over the last three years in children and have found that this system is effective at preventing nocturnal hypoglycaemia. The next stage of this research is to test the system for a longer period of time at home. In the present study the investigators are planning to study 16 adolescents aged 12-18 years on insulin pump therapy. During 21 nights glucose will be controlled by the computer and during the other 21 nights the subjects will make their own adjustments to the insulin therapy. The investigators will then analyze the data to determine the effect of the computer algorithm in keeping glucose levels between 3.9 and 8 mmol/L (normal levels) and reducing the time they spent with glucose below 3.9 mmol/L (hypoglycaemia). Subjects' response to the use of the system in terms of life-style change, daily diabetes management and fear of hypoglycaemia will be assessed. The investigators will also test for longer term glucose control by measuring glycated haemoglobin and other blood parameters.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

17

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
    • Cambridgeshire
      • Cambridge, Cambridgeshire, Det Forenede Kongerige, CB2 0QQ
        • Department of Paediatrics, Weston paediatric diabetes centre

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. The subject is between 12 and 18 years of age (inclusive)
  2. The subject has type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative
  3. The subject will all have been insulin pump user for at least 3 months, with good knowledge of insulin self-adjustment as judged by the investigator
  4. The subject willing to perform regular finger-prick blood glucose monitoring, with at least 4 blood glucose measurements taken every day
  5. HbA1c ≤ 10 % based on analysis from central laboratory or equivalent
  6. The subject is literate in English
  7. Able to accommodate on site or in close proximity member(s) of study team for supervised closed-loop night(s)

Exclusion Criteria:

  1. Non-type 1 diabetes mellitus including those secondary to chronic disease
  2. Any other 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
  3. Current treatment with drugs known to interfere with glucose metabolism, eg systemic corticosteroids, non-selective beta-blockers and MAO inhibitors etc
  4. Known or suspected allergy against insulin
  5. Subjects with clinical significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator
  6. Total daily insulin dose ≥ 2 IU/kg/day
  7. Pregnancy, planned pregnancy, or breast feeding
  8. Prolonged use of any continuous glucose monitoring devices over the last 1 month prior the study
  9. Severe visual impairment
  10. Severe hearing impairment
  11. Subjects using implanted internal pace-maker -

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Overnight closed-loop combined with real-time CGM
Enhed: Overnight closed-loop
The closed-loop system is purpose-built and comprises a hand-held computer containing the algorithm and communicating with the CGM device and the insulin pump.
Aktiv komparator: Real-time CGM alone
Enhed: Overnight closed-loop
The closed-loop system is purpose-built and comprises a hand-held computer containing the algorithm and communicating with the CGM device and the insulin pump.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Primary Efficacy Outcome
Tidsramme: At least 7 days of valid CGM nights (midnight-7:30)
The primary objective of the study is to assess the efficacy of continuous glucose monitoring (CGM) combined with overnight automated closed-loop glucose control in maintaining CGM glucose levels within the target range from 3.9 to 8.0 mmol/L, when compared with the use of CGM alone in the home setting.
At least 7 days of valid CGM nights (midnight-7:30)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Secondary outcomes
Tidsramme: At least 7 days of valid CGM nights (midnight-7:30)

As a secondary research question, the safety of overnight automated closed-loop glucose control in terms of number of episodes of severe hypoglycaemia as well as the number of subjects experiencing severe hypoglycaemia and other adverse events.

Furthermore, the frequency and duration of use of the closed-loop system will be evaluated. Subjects' perception in terms of life-style change, daily diabetes management and fear of hypoglycaemia will be assessed using questionnaires and a qualitative interview.
At least 7 days of valid CGM nights (midnight-7:30)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Cambridge

Samarbejdspartnere

Cambridge University Hospitals NHS Foundation Trust

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2012

Primær færdiggørelse (Faktiske)

1. marts 2013

Studieafslutning (Faktiske)

1. marts 2013

Datoer for studieregistrering

Først indsendt

14. oktober 2010

Først indsendt, der opfyldte QC-kriterier

14. oktober 2010

Først opslået (Skøn)

15. oktober 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. september 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. september 2013

Sidst verificeret

1. september 2013

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • APCam06

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Type 1 diabetes

Kliniske forsøg med Overnight closed-loop

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