Diabetes MellitusAPCam09NCT02129868
Automated Closed-loop in Children and Adolescents With Type 1 Diabetes
A study testing Closed-loop (Android Closed-Loop platform) in people with Diabetes Mellitus and Diabetes Mellitus, Type 1, run by University of Cambridge at 1 site in United Kingdom.
Trial summary
People with type 1 diabetes need regular insulin injections or continuous delivery of insulin using a pump. Keeping blood sugars in the normal range is known to reduce long term complications. However, achieving treatment goals can be very difficult due to the risk of low glucose levels (hypoglycaemia). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders
- What is being tested?
- Closed-loop (Android Closed-Loop platform)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The subject is between 6 and 18 years of age.
- The subject has had type 1 diabetes, as defined by WHO criteria 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 a good knowledge of insulin dose adjustment.
- HbA1c between below 11 % based on analysis from central laboratory.
- The subject is literate in English.
- The subject is willing to undertake all study related activities.
Who cannot join
- 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.
- Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers and MAO inhibitors.
- Known or suspected allergy against insulin.
- Subjects with clinically significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator
- Patient is pregnant, or breast feeding during the period of the study.
Show all 11Show fewer
- Total daily insulin dose ≥ 2 Units/kg/day
- Total daily insulin dose < 10 Units/day
- Severe visual impairment
- Severe hearing impairment
- Subjects using implanted internal pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-centre, Randomised, 2-period Cross-over Study to Assess the Efficacy and Safety of a Novel Automated Overnight Closed-loop Glucose Control System on Day 1 of Continuous Glucose Monitoring Sensor Insertion in Comparison to Day 3 to 4 After Sensor Insertion in Children and Adolescents With Type 1 Diabetes
People with type 1 diabetes need regular insulin injections or continuous delivery of insulin using a pump. Keeping blood sugars in the normal range is known to reduce long term complications. However, achieving treatment goals can be very difficult due to the risk of low glucose levels (hypoglycaemia). One solution is to use a system where the amount of insulin injected closely matches 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 a subcutaneous insulin pump. Previous studies conducted under carefully controlled clinical research facility environment, in Cambridge, United Kingdom, as well as several other centres have shown that closed-loop glucose control is superior to usual insulin pump therapy. The next logical step in the development pathway is to test closed loop systems in the home environment. An essential requirement for conducting closed-loop studies outside clinical research facility is an automated system where wireless data transmission takes place between the glucose sensor and insulin pump.
The purpose of the present study is to evaluate the efficacy and safety of automated overnight closed-loop, in children and adolescents with type 1 diabetes, using a novel system which has greatest potential for use in the home setting. The study will take place at a clinical research facility on two occasions, using a standardised protocol. The performance of the closed-loop system will be evaluated on day 1 of continuous glucose monitoring (CGM) sensor life as compared to on days 3 to 4 of sensor life. Data and experience gained from this study will be used for further refinements and development of the system for future home use.
Read the detailed description
The main objective of the current study is to evaluate the efficacy, safety and utility/reliability of a novel automated overnight closed-loop glucose control system in children and adolescents with type 1 diabetes. This will inform the future development of closed-loop systems in children and adolescents aged 6 to 18 years with type 1 diabetes.
This is an open-label, randomised, 2-period cross-over study, using the Medtronic Android closed loop platform or similar, comparing the safety and efficacy of overnight closed loop glucose control on day 1 compared with day 3 to 4 of CGM sensor life. Participants will be randomised to undergo two overnight studies in a clinical research facility, during which glucose levels will be controlled by the computer-based closed-loop algorithm on day 1 of CGM sensor insertion or day 3 to 4 after sensor insertion.
A total of 16 children and adolescents with T1D between 6 and 18 years of age will be recruited through the Outpatient Diabetes Clinic in the Department of Paediatrics, Addenbrooke's Hospital and Paediatric Diabetes Centres in London, Norwich, and Ipswich, to allow for 12 available for assessment. All participants will be on insulin pump treatment with a good knowledge of insulin dose adjustments. The study will take place at the Wellcome Trust Clinical Research Facility (WTCRF), Cambridge. Participants will be admitted at the clinical research facility in the evening and stay until the following morning. During the two closed-loop visits, automated closed-loop glucose control with wireless data transmission will be performed. A Model-Predictive-Control algorithm will determine the insulin infusion rate based on interstitial glucose measured by a continuous subcutaneous glucose monitoring (CGM) system. Intravenous sampling for glucose and insulin levels will also be carried out on both study visits for post hoc validation of glucose sensor data and for future modelling purposes.
The primary efficacy endpoint is the time spent in the target plasma glucose range from 3.9 to 8 mmol/L. Safety evaluation is focused on the frequency and duration of episodes of hypoglycaemia.
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Endocrine System Diseases, Autoimmune Diseases
- Being tested
- Closed-loop (Android Closed-Loop platform)
- Keywords
- Type 1 diabetes, Closed-loop glucose control, Artificial Pancreas, Continuous subcutaneous insulin infusion, Continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Endocrine System Diseases, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-loop (Android Closed-Loop platform)Device
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.
The Android Closed-Loop platform employs the Medtronic MiniMed Paradigm® Veo™ insulin pump system with CGM capability (use of MiniLink™Transmitter and sensor). A Radiofrequency (RF) translator module translates the RF protocol to Bluetooth® technology. An Android device containing an algorithm will use sensor glucose data to calculate pump strokes.
| Study group | Role | What they receive |
|---|---|---|
| Closed-loop on day 1 of CGM sensor life | Experimental | Glucose level is controlled by the automated closed-loop glucose control system on day 1 after CGM sensor insertion. Receives: Device: Closed-loop (Android Closed-Loop platform) |
| Closed-loop on day 3 of CGM sensor life | Active comparator | Glucose level is controlled by the automated closed-loop glucose control system on day 3 or 4 after CGM sensor insertion. Receives: Device: Closed-loop (Android Closed-Loop platform) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent with plasma glucose concentration in the target glucose range from 3.9 to 8.0 mmol/l.
The primary outcome measure is time spent with plasma glucose concentration in the target range (3.9-8.0mmol/L) between 21:30 on Day 1 and 07:30 on Day 2 (10 hours), as obtained with closed-loop insulin delivery on day 1 of CGM sensor insertion as compared with closed-loop insulin delivery on day 3 to 4 of CGM sensor insertion.
Measured: 10 hours
Secondary outcomes (7)
Time spent with plasma glucose concentration below the target range (<3.9mmol/L) between 21:30 on Day 1 and 07:30 on Day 2 (10 hours).
Measured: 10 hours
Time spent with plasma glucose concentration above the target range (>8mmol/L) between 21:30 on Day 1 and 07:30 on Day 2 (10 hours).
Measured: 10 hours
Mean and standard deviation of plasma glucose levels between 21:30 on Day 1 and 07:30 on Day 2 (10 hours).
Measured: 10 hours
Total insulin delivery between 21:30 on Day 1 and 07:30 on Day 2 (10 hours).
Measured: 10 hours
Total basal insulin delivery between 21:30 on Day 1 and 07:30 on Day 2 (10 hours).
Measured: 10 hours
Plasma insulin concentrations between 21:30 on Day 1 and 07:30 on Day 2 (10 hours).
Measured: 10 hours
Absolute relative difference between matched pairs of subcutaneous glucose sensor and reference plasma glucose.
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Dr Roman Hovorka, University of Cambridge
- Investigators
- Roman Hovorka, PhD, Study director, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129868
- Sponsor's protocol ID
- APCam09
- Acronym
- APCam09
- Status last verified
- Feb 2017
- First submitted
- 23 Apr 2014
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hovorka R, Allen JM, Elleri D, Chassin LJ, Harris J, Xing D, Kollman C, Hovorka T, Larsen AM, Nodale M, De Palma A, Wilinska ME, Acerini CL, Dunger DB. Manual closed-loop insulin delivery in children and adolescents with type 1 diabetes: a phase 2 randomised crossover trial. Lancet. 2010 Feb 27;375(9716):743-51. doi: 10.1016/S0140-6736(09)61998-X. Epub 2010 Feb 4.
PubMed 20138357Hovorka R, Kumareswaran K, Harris J, Allen JM, Elleri D, Xing D, Kollman C, Nodale M, Murphy HR, Dunger DB, Amiel SA, Heller SR, Wilinska ME, Evans ML. Overnight closed loop insulin delivery (artificial pancreas) in adults with type 1 diabetes: crossover randomised controlled studies. BMJ. 2011 Apr 13;342:d1855. doi: 10.1136/bmj.d1855.
PubMed 21493665Elleri D, Allen JM, Biagioni M, Kumareswaran K, Leelarathna L, Caldwell K, Nodale M, Wilinska ME, Acerini CL, Dunger DB, Hovorka R. Evaluation of a portable ambulatory prototype for automated overnight closed-loop insulin delivery in young people with type 1 diabetes. Pediatr Diabetes. 2012 Sep;13(6):449-53. doi: 10.1111/j.1399-5448.2012.00903.x. Epub 2012 Jul 23.
PubMed 22817340Kumareswaran K, Elleri D, Allen JM, Harris J, Xing D, Kollman C, Nodale M, Murphy HR, Amiel SA, Heller SR, Wilinska ME, Acerini CL, Evans ML, Dunger DB, Hovorka R. Meta-analysis of overnight closed-loop randomized studies in children and adults with type 1 diabetes: the Cambridge cohort. J Diabetes Sci Technol. 2011 Nov 1;5(6):1352-62. doi: 10.1177/193229681100500606.
PubMed 22226252Tauschmann M, Allen JM, Wilinska ME, Ruan Y, Thabit H, Acerini CL, Dunger DB, Hovorka R. Sensor Life and Overnight Closed Loop: A Randomized Clinical Trial. J Diabetes Sci Technol. 2017 May;11(3):513-521. doi: 10.1177/1932296816678631. Epub 2016 Nov 11.
PubMed 27837162
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-centre, Randomised, 2-period Cross-over Study to Assess the Efficacy and Safety of a Novel Automated Overnight Closed-loop Glucose Control System on Day 1 of Continuous Glucose Monitoring Sensor Insertion in Comparison to Day 3 to 4 After Sensor Insertion in Children and Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02129868
- Acronym / sponsor ID
- APCam09 / APCam09
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Endocrine System Diseases, Autoimmune Diseases
- Keywords
- Type 1 diabetes, Closed-loop glucose control, Artificial Pancreas, Continuous subcutaneous insulin infusion, Continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 2 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People with type 1 diabetes need regular insulin injections or continuous delivery of insulin using a pump. Keeping blood sugars in the normal range is known to reduce long term complications. However, achieving treatment goals can be very difficult due to the risk of low glucose levels (hypoglycaemia). One solution is to use a system where the amount of insulin injected closely matches 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 a subcutaneous insulin pump. Previous studies conducted under carefully controlled clinical research facility environment, in Cambridge, United Kingdom, as well as several other centres have shown that closed-loop glucose control is superior to usual insulin pump therapy. The next logical step in the development pathway is to test closed loop systems in the home environment. An essential requirement for conducting closed-loop studies outside clinical research facility is an automated system where wireless data transmission takes place between the glucose sensor and insulin pump.
The purpose of the present study is to evaluate the efficacy and safety of automated overnight closed-loop, in children and adolescents with type 1 diabetes, using a novel system which has greatest potential for use in the home setting. The study will take place at a clinical research facility on two occasions, using a standardised protocol. The performance of the closed-loop system will be evaluated on day 1 of continuous glucose monitoring (CGM) sensor life as compared to on days 3 to 4 of sensor life. Data and experience gained from this study will be used for further refinements and development of the system for future home use.
Detailed description
The main objective of the current study is to evaluate the efficacy, safety and utility/reliability of a novel automated overnight closed-loop glucose control system in children and adolescents with type 1 diabetes. This will inform the future development of closed-loop systems in children and adolescents aged 6 to 18 years with type 1 diabetes.
This is an open-label, randomised, 2-period cross-over study, using the Medtronic Android closed loop platform or similar, comparing the safety and efficacy of overnight closed loop glucose control on day 1 compared with day 3 to 4 of CGM sensor life. Participants will be randomised to undergo two overnight studies in a clinical research facility, during which glucose levels will be controlled by the computer-based closed-loop algorithm on day 1 of CGM sensor insertion or day 3 to 4 after sensor insertion.
A total of 16 children and adolescents with T1D between 6 and 18 years of age will be recruited through the Outpatient Diabetes Clinic in the Department of Paediatrics, Addenbrooke's Hospital and Paediatric Diabetes Centres in London, Norwich, and Ipswich, to allow for 12 available for assessment. All participants will be on insulin pump treatment with a good knowledge of insulin dose adjustments. The study will take place at the Wellcome Trust Clinical Research Facility (WTCRF), Cambridge. Participants will be admitted at the clinical research facility in the evening and stay until the following morning. During the two closed-loop visits, automated closed-loop glucose control with wireless data transmission will be performed. A Model-Predictive-Control algorithm will determine the insulin infusion rate based on interstitial glucose measured by a continuous subcutaneous glucose monitoring (CGM) system. Intravenous sampling for glucose and insulin levels will also be carried out on both study visits for post hoc validation of glucose sensor data and for future modelling purposes.
The primary efficacy endpoint is the time spent in the target plasma glucose range from 3.9 to 8 mmol/L. Safety evaluation is focused on the frequency and duration of episodes of hypoglycaemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed-loop on day 1 of CGM sensor life | Experimental | Device: Closed-loop (Android Closed-Loop platform)Glucose level is controlled by the automated closed-loop glucose control system on day 1 after CGM sensor insertion. |
| Closed-loop on day 3 of CGM sensor life | Active comparator | Device: Closed-loop (Android Closed-Loop platform)Glucose level is controlled by the automated closed-loop glucose control system on day 3 or 4 after CGM sensor insertion. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- The subject is between 6 and 18 years of age.
- The subject has had type 1 diabetes, as defined by WHO criteria 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 a good knowledge of insulin dose adjustment.
- HbA1c between below 11 % based on analysis from central laboratory.
- The subject is literate in English.
Key exclusion criteria (11 listed)
- 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.
- Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers and MAO inhibitors.
- Known or suspected allergy against insulin.
- Subjects with clinically significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed-loop (Android Closed-Loop platform)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. The Android Closed-Loop platform employs the Medtronic MiniMed Paradigm® Veo™ insulin pump system with CGM capability (use of MiniLink™Transmitter and sensor). A Radiofrequency (RF) translator module translates the RF protocol to Bluetooth® technology. An Android device containing an algorithm will use sensor glucose data to calculate pump strokes. | Device | Closed-loop on day 1 of CGM sensor life, Closed-loop on day 3 of CGM sensor life |
Primary outcome
Time spent with plasma glucose concentration in the target glucose range from 3.9 to 8.0 mmol/l.
Time frame: 10 hours
The primary outcome measure is time spent with plasma glucose concentration in the target range (3.9-8.0mmol/L) between 21:30 on Day 1 and 07:30 on Day 2 (10 hours), as obtained with closed-loop insulin delivery on day 1 of CGM sensor insertion as compared with closed-loop insulin delivery on day 3 to 4 of CGM sensor insertion.
7 secondary outcomes
Time spent with plasma glucose concentration below the target range (<3.9mmol/L) between 21:30 on Day 1 and 07:30 on Day 2 (10 hours).
Time frame: 10 hours
Time spent with plasma glucose concentration above the target range (>8mmol/L) between 21:30 on Day 1 and 07:30 on Day 2 (10 hours).
Time frame: 10 hours
Mean and standard deviation of plasma glucose levels between 21:30 on Day 1 and 07:30 on Day 2 (10 hours).
Time frame: 10 hours
Total insulin delivery between 21:30 on Day 1 and 07:30 on Day 2 (10 hours).
Time frame: 10 hours
Total basal insulin delivery between 21:30 on Day 1 and 07:30 on Day 2 (10 hours).
Time frame: 10 hours
Plasma insulin concentrations between 21:30 on Day 1 and 07:30 on Day 2 (10 hours).
Time frame: 10 hours
Absolute relative difference between matched pairs of subcutaneous glucose sensor and reference plasma glucose.
Time frame: 10 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Background: PubMed 20138357Hovorka R, Allen JM, Elleri D, Chassin LJ, Harris J, Xing D, Kollman C, Hovorka T, Larsen AM, Nodale M, De Palma A, Wilinska ME, Acerini CL, Dunger DB. Manual closed-loop insulin delivery in children and adolescents with type 1 diabetes: a phase 2 randomised crossover trial. Lancet. 2010 Feb 27;375(9716):743-51. doi: 10.1016/S0140-6736(09)61998-X. Epub 2010 Feb 4.
- Background: PubMed 21493665Hovorka R, Kumareswaran K, Harris J, Allen JM, Elleri D, Xing D, Kollman C, Nodale M, Murphy HR, Dunger DB, Amiel SA, Heller SR, Wilinska ME, Evans ML. Overnight closed loop insulin delivery (artificial pancreas) in adults with type 1 diabetes: crossover randomised controlled studies. BMJ. 2011 Apr 13;342:d1855. doi: 10.1136/bmj.d1855.
- Background: PubMed 22817340Elleri D, Allen JM, Biagioni M, Kumareswaran K, Leelarathna L, Caldwell K, Nodale M, Wilinska ME, Acerini CL, Dunger DB, Hovorka R. Evaluation of a portable ambulatory prototype for automated overnight closed-loop insulin delivery in young people with type 1 diabetes. Pediatr Diabetes. 2012 Sep;13(6):449-53. doi: 10.1111/j.1399-5448.2012.00903.x. Epub 2012 Jul 23.
- Background: PubMed 22226252Kumareswaran K, Elleri D, Allen JM, Harris J, Xing D, Kollman C, Nodale M, Murphy HR, Amiel SA, Heller SR, Wilinska ME, Acerini CL, Evans ML, Dunger DB, Hovorka R. Meta-analysis of overnight closed-loop randomized studies in children and adults with type 1 diabetes: the Cambridge cohort. J Diabetes Sci Technol. 2011 Nov 1;5(6):1352-62. doi: 10.1177/193229681100500606.
- Results publication: PubMed 27837162Tauschmann M, Allen JM, Wilinska ME, Ruan Y, Thabit H, Acerini CL, Dunger DB, Hovorka R. Sensor Life and Overnight Closed Loop: A Randomized Clinical Trial. J Diabetes Sci Technol. 2017 May;11(3):513-521. doi: 10.1177/1932296816678631. Epub 2016 Nov 11.
Related trials for Diabetes Mellitus
Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Recruiting
Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
Type 2 Diabetes
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Hovorka, PhD study director
University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed-loop (Android Closed-Loop platform) in people with Diabetes Mellitus and Diabetes Mellitus, Type 1, run by University of Cambridge at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent with plasma glucose concentration in the target glucose range from 3.9 to 8.0 mmol/l. (time frame: 10 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02129868, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.