Closing the Loop in Children and Adolescents With Type 1 Diabetes in the Home Setting (APCam08)
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Purpose
Type 1 diabetes (T1D) is one of the most common chronic childhood diseases requiring lifelong 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. We know that keeping blood sugars in the normal range will help prevent longterm diabetes-related complications involving the eyes, kidneys and heart. However, achieving treatment goals can be very difficult as the tighter we 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. We have been testing such a system in Cambridge over the last five years in children and have found that this system is effective at maintaining tight glucose control and preventing nocturnal hypoglycaemia. More recently the system has been tested in real life conditions in the home setting for three weeks during a pilot single-centre study. The next step is to extend the evaluation of closed-loop over a prolonged period of three months. In the present study we are planning to study 24 young people aged 6-18 years on insulin pump therapy. During three months glucose will be controlled by the computer and during the other three months the subjects will make their own adjustments to the insulin therapy. We aim to 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). Participants' response to the use of the system in terms of lifestyle change, daily diabetes management and fear of hypoglycaemia will be assessed. We will also test for longer term glucose control by measuring glycated haemoglobin (HbA1c).
| Condition | Intervention |
|---|---|
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Endocrine System Diseases Autoimmune Diseases |
Device: Overnight closed-loop Device: Real-time CGM alone |
| 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, Three-centre, Randomised, Two-period, Crossover 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 Children and Adolescents With Type 1 Diabetes on Subcutaneous Insulin Infusion Pump Therapy |
- The proportion of time spent overnight (midnight to 07:00) with glucose levels between 3.9 and 8.0 mmol/l, as assessed by adjusted CGM. [ Time Frame: 3 month home study period ] [ Designated as safety issue: No ]
- The proportion of nights when glucose levels drop below 3.6 mmol/l for 20 minutes or longer, as recorded by CGM [ Time Frame: 3 month home study period ] [ Designated as safety issue: No ]
- Time spent above and below the target glucose (3.9 to 8.0 mmol/l) based on continuous subcutaneous glucose monitoring (CGM) [ Time Frame: 3 month home study period ] [ Designated as safety issue: No ]
- The time with glucose levels in the significant hyperglycaemia range (glucose levels > 16.7 mmol/l) as recorded by continuous subcutaneous glucose monitoring. [ Time Frame: 3 month home study period ] [ Designated as safety issue: No ]
- Metabolic control assessed by HbA1c [ Time Frame: 3 month home study period ] [ Designated as safety issue: No ]
- Safety evaluation [ Time Frame: 3 month home study period ] [ Designated as safety issue: Yes ]Safety evaluation will comprise number of episodes of severe hypoglycaemia as well as the number of subjects experiencing severe hypoglycaemia and other adverse events, including ketone-positive hyperglycaemia. Subjects will be asked to measure blood or urine ketone levels on waking in the morning if their finger prick glucose is above 14mmol/l, as part of the safety evaluation for hyperglycaemia.
- Utility Evaluation [ Time Frame: 3 month home study period ] [ Designated as safety issue: No ]Utility evaluation is the frequency and duration of use of the closed-loop system combined with CGM as compared to the use of real time CGM alone, and the subjects' response in terms of life-style change, daily diabetes management and fear of hypoglycaemia, as evaluated by questionnaires and a semi-structured qualitative interview.
| Estimated Enrollment: | 24 |
| Study Start Date: | May 2013 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Overnight closed-loop combined with CGM
Glucose level is controlled by the automated closed loop glucose control system. After initial training with the closed-loop system devices, subjects will use the closed-loop system overnight at home for a total duration of 12 weeks.
|
Device: Overnight closed-loop
The closed-loop system is purpose-built and comprises a hand-held computer containing a model predictive control (MPC) based glucose control algorithm and communicating with the CGM device and the insulin pump.
|
|
Active Comparator: Real-time CGM alone
The subjects will use the study CGM alone at home for the period of 12 weeks. Glucose level will be controlled by usual insulin pump therapy in conjunction with real time continuous glucose monitoring (CGM)
|
Device: Real-time CGM alone
Subject glucose level controlled by usual insulin pump therapy in conjunction with real time continuous glucose monitoring (CGM)
|
Eligibility| Ages Eligible for Study: | 6 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The subject is between 6 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 have been an insulin pump user for at least 3 months, with good knowledge of insulin self-adjustment as judged by the investigator
- The subject is 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
Exclusion Criteria:
- Known or suspected allergy against insulin
- Non-type 1 diabetes mellitus including those secondary to chronic disease
- Untreated celiac 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, e.g. 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
- Total daily insulin dose < 10 IU/day
- Pregnancy, planned pregnancy, or breast feeding
- Severe visual impairment
- Severe hearing impairment
- Subjects using implanted internal pace-maker
Contacts and Locations| Contact: Ranna El-Khairi, MBBS, MRCPCH | +44 1223 769 069 | re298@medschl.cam.ac.uk |
| United Kingdom | |
| University of Cambridge | Not yet recruiting |
| Cambridge, United Kingdom, CB2 0QQ | |
| Contact: Ranna El-Khairi, MBBS, MRCPCH +44 (0)1224 769069 re298@medschl.cam.ac.uk | |
| Principal Investigator: David Dunger, MD, FRCPCH | |
| Leeds Teaching Hospitals | Not yet recruiting |
| Leeds, United Kingdom, LS9 7TF | |
| Contact: Fiona Campbell, MD, FRCPCH +44 (0)1132065924 Fiona.Campbell@leedsth.nhs.uk | |
| Principal Investigator: Fiona Campbell, MD, FRCPCH | |
| University College London Hospital | Not yet recruiting |
| London, United Kingdom, NW1 2BU | |
| Contact: Peter Hindmarsh, MD, FRCPCH +44 (0)2034479221 peter.hindmarsh@nhs.net | |
| Principal Investigator: Peter Hindmarsh, MD, FRCPCH | |
| Study Director: | Roman Hovorka, PhD | University of Cambridge |
| Principal Investigator: | David Dunger, MD, FRCPCH | University of Cambridge |
| Principal Investigator: | Peter Hindmarsh, MD, FRCPCH | University College London Hospitals |
| Principal Investigator: | Fiona Campbell, MD, FRCPCH | Leeds Teaching Hospitals |
More Information
Publications:
| Responsible Party: | Dr Roman Hovorka, Director of Research, University of Cambridge |
| ClinicalTrials.gov Identifier: | NCT01778348 History of Changes |
| Other Study ID Numbers: | APCam08 |
| Study First Received: | January 25, 2013 |
| Last Updated: | January 25, 2013 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by University of Cambridge:
|
Type 1 diabetes Closed-loop glucose control Artificial Pancreas Continuous subcutaneous insulin infusion Continuous glucose monitoring |
Additional relevant MeSH terms:
|
Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Metabolic Diseases Glucose Metabolism Disorders |
Immune System Diseases Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013