Closing the Loop in Youth With Type 1 Diabetes in the Home Setting
22 september 2013 uppdaterad av: 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.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
17
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Cambridgeshire
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Cambridge, Cambridgeshire, Storbritannien, CB2 0QQ
- Department of Paediatrics, Weston paediatric diabetes centre
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
12 år till 18 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- The subject is between 12 and 18 years of age (inclusive)
- The subject has type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative
- 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
- The subject willing to perform regular finger-prick blood glucose monitoring, with at least 4 blood glucose measurements taken every day
- HbA1c ≤ 10 % based on analysis from central laboratory or equivalent
- The subject is literate in English
- Able to accommodate on site or in close proximity member(s) of study team for supervised closed-loop night(s)
Exclusion Criteria:
- Non-type 1 diabetes mellitus including those secondary to chronic disease
- 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
- Current treatment with drugs known to interfere with glucose metabolism, eg systemic corticosteroids, non-selective beta-blockers and MAO inhibitors etc
- Known or suspected allergy against insulin
- Subjects with clinical significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator
- Total daily insulin dose ≥ 2 IU/kg/day
- Pregnancy, planned pregnancy, or breast feeding
- Prolonged use of any continuous glucose monitoring devices over the last 1 month prior the study
- Severe visual impairment
- Severe hearing impairment
- Subjects using implanted internal pace-maker -
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Aktiv komparator: Overnight closed-loop combined with real-time CGM
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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.
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Aktiv komparator: Real-time CGM alone
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Primary Efficacy Outcome
Tidsram: At least 7 days of valid CGM nights (midnight-7:30)
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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.
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At least 7 days of valid CGM nights (midnight-7:30)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Secondary outcomes
Tidsram: At least 7 days of valid CGM nights (midnight-7:30)
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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)
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Samarbetspartners och utredare
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Sponsor
Samarbetspartners
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Thabit H, Elleri D, Leelarathna L, Allen J, Lubina-Solomon A, Stadler M, Walkinshaw E, Iqbal A, Choudhary P, Wilinska M, Barnard K, Heller S, Amiel S, Evans M, Dunger D, Hovorka R. Unsupervised overnight closed loop insulin delivery during free living: analysis of randomised cross-over home studies in adults and adolescents with type 1 diabetes. Lancet. 2015 Feb 26;385 Suppl 1:S96. doi: 10.1016/S0140-6736(15)60411-1.
- Thabit H, Leelarathna L, Wilinska ME, Elleri D, Allen JM, Lubina-Solomon A, Walkinshaw E, Stadler M, Choudhary P, Mader JK, Dellweg S, Benesch C, Pieber TR, Arnolds S, Heller SR, Amiel SA, Dunger D, Evans ML, Hovorka R. Accuracy of Continuous Glucose Monitoring During Three Closed-Loop Home Studies Under Free-Living Conditions. Diabetes Technol Ther. 2015 Nov;17(11):801-7. doi: 10.1089/dia.2015.0062. Epub 2015 Aug 4.
- Hovorka R, Elleri D, Thabit H, Allen JM, Leelarathna L, El-Khairi R, Kumareswaran K, Caldwell K, Calhoun P, Kollman C, Murphy HR, Acerini CL, Wilinska ME, Nodale M, Dunger DB. Overnight closed-loop insulin delivery in young people with type 1 diabetes: a free-living, randomized clinical trial. Diabetes Care. 2014;37(5):1204-11. doi: 10.2337/dc13-2644.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juni 2012
Primärt slutförande (Faktisk)
1 mars 2013
Avslutad studie (Faktisk)
1 mars 2013
Studieregistreringsdatum
Först inskickad
14 oktober 2010
Först inskickad som uppfyllde QC-kriterierna
14 oktober 2010
Första postat (Uppskatta)
15 oktober 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
24 september 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 september 2013
Senast verifierad
1 september 2013
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- APCam06
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