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

NCT ID: NCT01221467

Last Updated: 2013-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-03-31

Brief Summary

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Overnight closed-loop combined with real-time CGM

Group Type: ACTIVE_COMPARATOR

Overnight closed-loop

Intervention Type: DEVICE

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.

Real-time CGM alone

Group Type: ACTIVE_COMPARATOR

Overnight closed-loop

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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 -

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role: collaborator

University of Cambridge

OTHER

Sponsor Role: lead

Responsible Party

Dr Roman Hovorka

Principal Research Associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Paediatrics, Weston paediatric diabetes centre

Cambridge, Cambridgeshire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 26312919 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26241693 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24757227 (View on PubMed)

Other Identifiers

APCam06

Identifier Type: -

Identifier Source: org_study_id