Closing the Loop in Youth With Type 1 Diabetes in the Home Setting - Full Text View

Purpose

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.

Condition	Intervention	Phase
Type 1 Diabetes	Device: Overnight closed-loop	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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.

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Type 1

U.S. FDA Resources

Further study details as provided by University of Cambridge:

Primary Outcome Measures:

Primary Efficacy Outcome [ Time Frame: At least 7 days of valid CGM nights (midnight-7:30) ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Secondary outcomes [ Time Frame: At least 7 days of valid CGM nights (midnight-7:30) ] [ Designated as safety issue: Yes ]
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.


Enrollment:	17
Study Start Date:	June 2012
Study Completion Date:	March 2013
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Overnight closed-loop combined with real-time CGM	Device: 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.
Active Comparator: Real-time CGM alone	Device: 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.

Eligibility


Ages Eligible for Study:	12 Years to 18 Years (Child, Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 -

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01221467

Locations


United Kingdom
Department of Paediatrics, Weston paediatric diabetes centre
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ

Sponsors and Collaborators

University of Cambridge

Cambridge University Hospitals NHS Foundation Trust

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Dr Roman Hovorka, Principal Research Associate, University of Cambridge
ClinicalTrials.gov Identifier:	NCT01221467 History of Changes
Other Study ID Numbers:	APCam06
Study First Received:	October 14, 2010
Last Updated:	September 22, 2013
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases	Endocrine System Diseases Autoimmune Diseases Immune System Diseases

ClinicalTrials.gov processed this record on September 27, 2016