Type 1 DiabetesAP@home04NCT01961622
Closing the Loop in Adults With Sub-optimally Controlled Type 1 Diabetes Under Free Living Conditions
A study testing CSII with real-time CGM in people with Type 1 Diabetes, run by University of Cambridge at 3 sites in 3 countries.
Trial summary
The main objective of this study is to determine whether day and night closed-loop insulin delivery for 12 weeks under free living conditions is superior to addition of real-time continuous glucose monitoring in adults with type 1 diabetes and sub-optimal glucose control on insulin pump therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- CSII with real-time CGM
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Apr 2014to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has type 1 diabetes as defined by WHO
- The subject is 18 years of age or older
- The subject will have been on an insulin pump for at least 6 months with good knowledge of insulin self-adjustment including carbohydrate counting
- The subject is treated with one of the rapid acting insulin analogues (Insulin Aspart, Insulin Lispro or Insulin Glulisine)
- HbA1c ≥7.5% (58mmol/mmol) and ≤ 10% (86 mmol/mmol) based on analysis from central laboratory or equivalent
- The subject is willing to perform regular finger-prick blood glucose monitoring, with at least 6 measurements per day
Show all 10Show fewer
- The subject is willing to wear closed-loop system at home and at work place
- The subject is willing to follow study specific instructions
- The subject is willing to upload pump and CGM data at regular intervals
- Female subjects of child bearing age should be on effective contraception and must have a negative urine-HCG pregnancy test at screening. In addition in Germany, women of childbearing potential must use a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e. less than 1% per year) and must use two independent methods of contraception, e.g. diaphragm and spermicide-coated condom.
Who cannot join
- Non-type 1 diabetes mellitus
- Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
- Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator
- Known or suspected allergy against insulin
- Subjects with clinically significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator
- Significantly reduced hypoglycaemia awareness as judged by the investigator
Show all 42Show fewer
- More than one episode of severe hypoglycaemia as defined by American Diabetes Association (31) in preceding 6 months (Severe hypoglycaemia is defined as an event requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions).
- Random C-peptide > 100pmol/l with concomitant plasma glucose >4 mM(72 mg/dl)
- Total daily insulin dose > 2 IU/kg/day
- Subject is pregnant or breast feeding or planning pregnancy in near future (within next 3 months)
- Severe visual impairment
- Severe hearing impairment
- Subjects using implanted internal pacemaker
- Lack of reliable telephone facility for contact
- Subject not proficient in English (UK) or German (Germany and Austria)
- Subjects who are living alone
- Additional exclusion criteria specific for Austria and Germany
- Positive results on urine drug screen (amphetamines/metamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
- Positive alcohol breath test.
- Additional exclusion criteria specific for Germany only
- Positive reaction to any of the following tests: hepatitis B surface (HBs) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 antibodies, anti-HIV2 antibodies.
- Significantly reduced hypoglycaemia awareness withGold score ≥ 4 according to Geddes J et al, Diabetes Care 2007
- Serious macro- and microangiopathy
- Serious anomalies of the skin
- Serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) located at places of the body, which potentially are possible to be used for localisation of the glucose sensor)
- Renal insufficiency
- Epilepsy
- Eating disorders (like bulimia or anorexia nervosa)
- Disorders of the lipid metabolism
- Blood transfusion requiring patients
- Psychiatric diseases and related conditions
- Patients with frequent catheter abscesses having occurred in connection with the pump therapy
- Patients with medically documented allergy towards the adhesive (glue) of plasters
- Abnormal blood values for:
- the creatinine clearance,
- erythropoietin,
- TSH.
- Patients with the following concomitant medications or misuse of substances:
- steroids,
- anticoagulant therapies.
- Patients with a planned intervention under general anaesthesia.
- Patients who do shift work
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: An Open-label, Multi-centre, Randomised, Two-period, Crossover Study to Assess the Efficacy, Safety and Utility of 12 Week Day and Night Automated Closed-loop Glucose Control Under Free Living Conditions Compared to Conventional Insulin Pump Therapy Combined With Continuous Glucose Monitoring in Adults With Type 1 Diabetes With Sub-optimal Glucose Control
The main objective of this study is to determine whether day and night closed-loop insulin delivery for 12 weeks under free living conditions is superior to addition of real-time continuous glucose monitoring in adults with type 1 diabetes and sub-optimal glucose control on insulin pump therapy.
This is an open-label, multi centre, randomised, crossover design study, involving a 6 to 8 week run-in period, during which glucose control will be optimised by a professional pump educator, followed by two 3 months study periods during which glucose levels will be controlled either by an automated closed-loop system or by subjects usual insulin pump therapy augmented with real-time continuous glucose monitoring in random order. A total of up to 42 adults (aiming for 30 completed subjects) aged 18 years and older with T1D on insulin pump therapy will be recruited through diabetes clinics and other established methods in participating centres. Subjects who drop out of the study within the first 6 weeks of the first intervention arm will be replaced.
Read more
Subjects will receive appropriate training in the safe use of closed-loop insulin delivery system. Subjects will have regular contact with the study team during the home study phase including 24/7 telephone support. Subjects will be discouraged from international travel during the first two weeks of closed-loop use.
The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM (adjusted for potential over-estimation) during home stay. Secondary outcomes are the HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics.
- Conditions
- Type 1 Diabetes
- Being tested
- Florence D2A or similar closed loop glucose control system, CSII with real-time CGM
- Keywords
- Type 1 diabetes, Closed loop insulin delivery, Continuous subcutaneous glucose monitoring, Continuous subcutaneous insulin infusion
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Florence D2A or similar closed loop glucose control systemDevice
Subject's glucose level will be controlled by the Florence D2A or similar automated closed loop glucose control system. The system comprises of FreeStyle Navigator 2 ® Continuous Glucose Monitoring (CGM) System (Abbott Diabetes Care, Alameda, CA, USA), Dana R Diabecare subcutaneous insulin infusion pump (Sooil Corp. Seoul, South Korea)or similar insulin pump, and MPC-based glucose control algorithm running on a smartphone
CSII with real-time CGMDevice
Subject glucose level controlled by usual insulin pump therapy in conjunction with real time continuous glucose monitoring (CGM)
| Study group | Role | What they receive |
|---|---|---|
| Florence D2A Closed Loop Glucose control | Experimental | Subjects glucose levels are controlled by Florence D2A or similar closed loop insulin delivery system Receives: Device: Florence D2A or similar closed loop glucose control system |
| CSII with real-time CGM | Active comparator | Subject glucose level controlled by usual insulin pump therapy in conjunction with real time continuous glucose monitoring (FreeStyle Navigator CGM) Receives: Device: CSII with real-time CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent in the target glucose range from 3.9 to 10.0 mmol/l based on subcutaneous glucose monitoring
Time spent in the target glucose range from 3.9 to 10.0 mmol/l based on subcutaneous glucose monitoring (CGM) during the 90 days of home stay. Intention to treat basis.
Measured: 90 days
Secondary outcomes (15)
HbA1c
Measure of average glycaemic control during study period
Measured: 90 days
Insulin dose
Total, basal and bolus insulin dose during 90 days of home periods
Measured: 90 days
Adverse Events
Safety evaluation will comprise the number of episodes of hypoglycaemia, significant ketonemia (> 3.0mmol/l)as well as nature and severity of any other adverse events
Measured: 10 months
Utility Evaluation
Utility evaluation is the frequency and duration of use of the closed-loop system at home and time between failures of closed-loop system components.
Measured: 90 days
Continuous subcutaneous glucose monitoring (CGM) based outcome
Time spent above and below the target glucose 3.9 to 10.0 mmol/l, during the 90 days of home periods
Measured: 90 days
Continuous subcutaneous glucose monitoring (CGM) based outcome
Average,standard deviation and coefficient of variation of glucose levels during 90 days of home periods
Measured: 90 days
Continuous subcutaneous glucose monitoring (CGM) based outcome
The time with glucose levels < 3.5 mmol/l and <2.8 mmol/l during 90 days of home periods
Measured: 90 days
Continuous subcutaneous glucose monitoring (CGM) based outcome
The time with glucose levels in the significant hyperglycaemia,(glucose levels > 16.7 mmol/l during 90 days of home periods
Measured: 90 days
Continuous subcutaneous glucose monitoring (CGM) based outcome
Low Blood Glucose Index during 90 days of home periods
Measured: 90 days
Continuous subcutaneous glucose monitoring (CGM) based outcome
Duration of periods when sensor glucose values was below 3.5mmol/l for at least 20 minutes
Measured: 90 days
Continuous subcutaneous glucose monitoring (CGM) based outcome
The "Area Under the Curve" below 3.5 mmol/l during 90 days home periods
Measured: 90 days
Continuous subcutaneous glucose monitoring (CGM) based outcome
Between 24 hour period variability: Coefficient of variation of CGM glucose between 24 hour periods (midnight to midnight)
Measured: 90 days
Continuous subcutaneous glucose monitoring (CGM) based outcome
Glucose concentration in the target range (3.9-10.0mmol/L), and above and below target range based on adjusted CGM. Adjustment described in Hovorka R et. al.; Diabetes Technol Ther 14:1-9, 2012
Measured: 90 days
Continuous subcutaneous glucose monitoring (CGM) based outcome during overnight period between 23:00 and 08:00
Time spent with CGM glucose concentration in the target range (3.9-8.0mmol/L), Mean CGM glucose levels, The AUC below 3.5mmol/l, CV of CGM glucose levels, Coefficient of variation of CGM glucose between nights and Total insulin dose during overnight period between 23:00 and 08:00
Measured: 90 days
Continuous subcutaneous glucose monitoring (CGM) based outcome during day period between 08:00 to 23:00
Time spent with CGM glucose concentration in the target range (3.9-10.0mmol/L), Mean CGM glucose levels, The AUC below 3.5mmol/l, CV of CGM glucose levels, Coefficient of variation of CGM glucose between days and Total insulin dose during day period between 08:00 to 23:00
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startApr 2014
- Primary completionMay 2015
- Study completionMay 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 Type 1 DiabetesStudies 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Profil Institut für Stoffwechselforschung GmbH, Medical University of Graz
- Responsible party
- Principal investigator, Dr Roman Hovorka, University of Cambridge
- Investigators
- Roman Hovorka, PhD, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961622
- Sponsor's protocol ID
- AP@home04
- Acronym
- AP@home04
- Status last verified
- Jun 2015
- First submitted
- 30 Aug 2013
- Last updated
- 8 Jun 2015
- 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 21493665Hovorka R. Closed-loop insulin delivery: from bench to clinical practice. Nat Rev Endocrinol. 2011 Feb 22;7(7):385-95. doi: 10.1038/nrendo.2011.32.
PubMed 21343892Thabit H, Tauschmann M, Allen JM, Leelarathna L, Hartnell S, Wilinska ME, Acerini CL, Dellweg S, Benesch C, Heinemann L, Mader JK, Holzer M, Kojzar H, Exall J, Yong J, Pichierri J, Barnard KD, Kollman C, Cheng P, Hindmarsh PC, Campbell FM, Arnolds S, Pieber TR, Evans ML, Dunger DB, Hovorka R; New Collective Author. Home Use of an Artificial Beta Cell in Type 1 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2129-2140. doi: 10.1056/NEJMoa1509351. Epub 2015 Sep 17.
PubMed 26379095Leelarathna L, Dellweg S, Mader JK, Barnard K, Benesch C, Ellmerer M, Heinemann L, Kojzar H, Thabit H, Wilinska ME, Wysocki T, Pieber TR, Arnolds S, Evans ML, Hovorka R; AP@home consortium. Assessing the effectiveness of 3 months day and night home closed-loop insulin delivery in adults with suboptimally controlled type 1 diabetes: a randomised crossover study protocol. BMJ Open. 2014 Sep 3;4(9):e006075. doi: 10.1136/bmjopen-2014-006075.
PubMed 25186158
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-centre, Randomised, Two-period, Crossover Study to Assess the Efficacy, Safety and Utility of 12 Week Day and Night Automated Closed-loop Glucose Control Under Free Living Conditions Compared to Conventional Insulin Pump Therapy Combined With Continuous Glucose Monitoring in Adults With Type 1 Diabetes With Sub-optimal Glucose Control
- ClinicalTrials.gov ID
- NCT01961622
- Acronym / sponsor ID
- AP@home04 / AP@home04
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Closed loop insulin delivery, Continuous subcutaneous glucose monitoring, Continuous subcutaneous insulin infusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Profil Institut für Stoffwechselforschung GmbH, Medical University of Graz
- Study start
- Apr 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 11 Oct 2013 (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.
The main objective of this study is to determine whether day and night closed-loop insulin delivery for 12 weeks under free living conditions is superior to addition of real-time continuous glucose monitoring in adults with type 1 diabetes and sub-optimal glucose control on insulin pump therapy.
This is an open-label, multi centre, randomised, crossover design study, involving a 6 to 8 week run-in period, during which glucose control will be optimised by a professional pump educator, followed by two 3 months study periods during which glucose levels will be controlled either by an automated closed-loop system or by subjects usual insulin pump therapy augmented with real-time continuous glucose monitoring in random order. A total of up to 42 adults (aiming for 30 completed subjects) aged 18 years and older with T1D on insulin pump therapy will be recruited through diabetes clinics and other established methods in participating centres. Subjects who drop out of the study within the first 6 weeks of the first intervention arm will be replaced.
Subjects will receive appropriate training in the safe use of closed-loop insulin delivery system. Subjects will have regular contact with the study team during the home study phase including 24/7 telephone support. Subjects will be discouraged from international travel during the first two weeks of closed-loop use.
The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM (adjusted for potential over-estimation) during home stay. Secondary outcomes are the HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Florence D2A Closed Loop Glucose control | Experimental | Device: Florence D2A or similar closed loop glucose control systemSubjects glucose levels are controlled by Florence D2A or similar closed loop insulin delivery system |
| CSII with real-time CGM | Active comparator | Device: CSII with real-time CGMSubject glucose level controlled by usual insulin pump therapy in conjunction with real time continuous glucose monitoring (FreeStyle Navigator CGM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The subject has type 1 diabetes as defined by WHO
- The subject is 18 years of age or older
- The subject will have been on an insulin pump for at least 6 months with good knowledge of insulin self-adjustment including carbohydrate counting
- The subject is treated with one of the rapid acting insulin analogues (Insulin Aspart, Insulin Lispro or Insulin Glulisine)
- HbA1c ≥7.5% (58mmol/mmol) and ≤ 10% (86 mmol/mmol) based on analysis from central laboratory or equivalent
Key exclusion criteria (42 listed)
- Non-type 1 diabetes mellitus
- Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
- Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator
- 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 |
|---|---|---|
| Florence D2A or similar closed loop glucose control systemSubject's glucose level will be controlled by the Florence D2A or similar automated closed loop glucose control system. The system comprises of FreeStyle Navigator 2 ® Continuous Glucose Monitoring (CGM) System (Abbott Diabetes Care, Alameda, CA, USA), Dana R Diabecare subcutaneous insulin infusion pump (Sooil Corp. Seoul, South Korea)or similar insulin pump, and MPC-based glucose control algorithm running on a smartphone | Device | Florence D2A Closed Loop Glucose control |
| CSII with real-time CGMSubject glucose level controlled by usual insulin pump therapy in conjunction with real time continuous glucose monitoring (CGM) | Device | CSII with real-time CGM |
Primary outcome
Time spent in the target glucose range from 3.9 to 10.0 mmol/l based on subcutaneous glucose monitoring
Time frame: 90 days
Time spent in the target glucose range from 3.9 to 10.0 mmol/l based on subcutaneous glucose monitoring (CGM) during the 90 days of home stay. Intention to treat basis.
15 secondary outcomes
HbA1c
Time frame: 90 days
Insulin dose
Time frame: 90 days
Adverse Events
Time frame: 10 months
Utility Evaluation
Time frame: 90 days
Continuous subcutaneous glucose monitoring (CGM) based outcome
Time frame: 90 days
Continuous subcutaneous glucose monitoring (CGM) based outcome
Time frame: 90 days
Continuous subcutaneous glucose monitoring (CGM) based outcome
Time frame: 90 days
Continuous subcutaneous glucose monitoring (CGM) based outcome
Time frame: 90 days
Continuous subcutaneous glucose monitoring (CGM) based outcome
Time frame: 90 days
Continuous subcutaneous glucose monitoring (CGM) based outcome
Time frame: 90 days
Continuous subcutaneous glucose monitoring (CGM) based outcome
Time frame: 90 days
Continuous subcutaneous glucose monitoring (CGM) based outcome
Time frame: 90 days
Continuous subcutaneous glucose monitoring (CGM) based outcome
Time frame: 90 days
Continuous subcutaneous glucose monitoring (CGM) based outcome during overnight period between 23:00 and 08:00
Time frame: 90 days
Continuous subcutaneous glucose monitoring (CGM) based outcome during day period between 08:00 to 23:00
Time frame: 90 days
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 8 Jun 2015.
- 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 21343892Hovorka R. Closed-loop insulin delivery: from bench to clinical practice. Nat Rev Endocrinol. 2011 Feb 22;7(7):385-95. doi: 10.1038/nrendo.2011.32.
- Derived from this study: PubMed 26379095Thabit H, Tauschmann M, Allen JM, Leelarathna L, Hartnell S, Wilinska ME, Acerini CL, Dellweg S, Benesch C, Heinemann L, Mader JK, Holzer M, Kojzar H, Exall J, Yong J, Pichierri J, Barnard KD, Kollman C, Cheng P, Hindmarsh PC, Campbell FM, Arnolds S, Pieber TR, Evans ML, Dunger DB, Hovorka R; New Collective Author. Home Use of an Artificial Beta Cell in Type 1 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2129-2140. doi: 10.1056/NEJMoa1509351. Epub 2015 Sep 17.
- Derived from this study: PubMed 25186158Leelarathna L, Dellweg S, Mader JK, Barnard K, Benesch C, Ellmerer M, Heinemann L, Kojzar H, Thabit H, Wilinska ME, Wysocki T, Pieber TR, Arnolds S, Evans ML, Hovorka R; AP@home consortium. Assessing the effectiveness of 3 months day and night home closed-loop insulin delivery in adults with suboptimally controlled type 1 diabetes: a randomised crossover study protocol. BMJ Open. 2014 Sep 3;4(9):e006075. doi: 10.1136/bmjopen-2014-006075.
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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 principal investigator
University of Cambridge
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSII with real-time CGM in people with Type 1 Diabetes, run by University of Cambridge at 3 sites in 3 countries.
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 10 inclusion and 42 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 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria, Germany, 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 in the target glucose range from 3.9 to 10.0 mmol/l based on subcutaneous glucose monitoring (time frame: 90 days). 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 NCT01961622, 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 8 Jun 2015.