Type 1 DiabetesNCT02397265
Clinical Assessment of a Closed-loop System With Glucagon, Exercise and Mixed Meals
A study testing Bi-hormonal closed loop pump, Standard opened loop pump and Insulin closed loop in people with Type 1 Diabetes, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The diabetes technology group at Imperial College have developed a bio-inspired artificial pancreas (BiAP) system which uses a control algorithm based on a mathematical model of beta-cell physiology. 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?
- Bi-hormonal closed loop pump, Standard opened loop pump and Insulin closed loop
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Dec 2014to 22 Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adults over 18 years of age
- Type 1 diabetes confirmed on the basis of clinical features and a fasting c-peptide <200 pmol/L
- Type 1 diabetes for greater than 1 year
- Continuous subcutaneous insulin infusion for greater than 6 months
- HbA1c < 10% (86mmol/mol)
Who cannot join
- Recurrent severe hypoglycaemia and hypoglycaemia unawareness
- Pregnant or planning pregnancy
- Breastfeeding
- Enrolled in other clinical trials
- Have active malignancy or under investigation for malignancy
- Allergic to lactose
- Allergic to glucagon
Trial locations and contacts
1 site in 1 country.
About this study
The diabetes technology group at Imperial College have developed a bio-inspired artificial pancreas (BiAP) system which uses a control algorithm based on a mathematical model of beta-cell physiology. The algorithm is implemented on a miniature silicon microchip within a portable handheld device, which interfaces the components of the artificial pancreas.
Development of closed-loop insulin delivery devices to intensify control without hypoglycaemia has been extensively reviewed and have shown encouraging results . However, they have not yet proven to be robust when challenged with uncertainty and the external challenges (such as mixed meal contents, physical exercise, physiological stress and intercurrent illness) that people with Type 1 Diabetes Mellitus (T1DM) may be exposed to outside the clinical environment.
Read more
The principal research objective is to assess the safety and efficacy of a closed-loop system for T1DM compared to standard insulin pump therapy (open-loop). The primary outcome from the studies will be % time spent with a glucose concentration in the target range (3.9-10.0mmol/l). This outcome incorporates safety as it ensures subjects do not have low or high glucose excursions and is the principal measure of efficacy for closed-loop insulin delivery systems in the scientific literature. Other measured outcomes will be % time spent in euglycaemia (3.9-7.8mmol/l), % time spent in hypoglycaemia (<3.9mmol/l), % time spent in hyperglycaemia (>10mmol/l), mean venous blood and sensor glucose, glycaemic variability as measured by standard metrics (Standard Deviation, Continuous Overlapping Net Glycaemic Action, Lability Index, J-Index, Glycaemic Risk Assessment Diabetes Equation, Mean Of Daily Differences, Mean Amplitude of Glucose Excursion, Average Daily Risk Range, M-VALUE, Mean Average Glucose), glycaemic risk as measured by Low Blood Glucose Index (LBGI) and High Blood Glucose Index (HBGI), closed-loop error grid analysis, glucose area under the curve. All measures have been previously published and validated.
This clinical trial protocol assesses the artificial pancreas system in three separate sub-studies:
- In a bi-hormonal (insulin and glucagon) configuration
- During and after exercise with bi-hormonal closed loop, and standard insulin opened loop
- During and after meals of mixed composition with bi-hormonal closed loop, and standard insulin opened loop
Read the detailed description
Methodology Randomised controlled cross-over open label study
Sub study 1 (n=10)
In sub-study 1 which includes the first bio-inspired artificial pancreas study using bi-hormonal (insulin and glucagon) control a fasting 6-hour bi-hormonal closed-loop study will be conducted to assess proof of concept and safety prior to the 25-hour randomised controlled crossover study
Each subject will then be randomised to attend either a closed-loop visit or an open-loop visit first. Once either visit is completed each subject will crossover and attend the remaining visit.
Sub-study 2 (n=20) The aim of sub-study 2 is to challenge the bi-hormonal pump during a moderate exercise. Subjects will be initially randomised to either the bi-hormonal or the standard opened loop and then cross over. Each study will last for 25 hours
- Exercise protocol: Subjects will be connected to the gas analyser and heart rate/ECG monitor as per COSMED manufacturer instructions.
The oxygen consumption (VO2)/Carbon dioxide production (VCO2) and heart rate/ECG trace will be displayed continuously in real time while the subject is exercising.
Warm-up: 3 minutes of cycling at low resistance (20-30 watts) while maintaining a speed of 60-80 revolutions per minute After the warm-up the subjects will undergo a 30 minutes moderate intensity exercise session on the bike aiming to maintain their VO2 between 10-20% above their 1st ventilatory anaerobic threshold. If their VO2 falls below or goes above this level then the resistance will be increased or decreased accordingly. The target VO2 and the starting resistance (watts) will be individually set based on their baseline exercise test outcome.
The estimated time needed to complete the exercise test is 35-40 minutes.
Real-time continuous glucose monitoring alarms will be set at 4mmol/L and 15mmol/L and will be audible by the subject and the research team.
The glucagon solution will be replaced with a freshly reconstituted glucagon solution every 8 hours throughout the closed-loop study If the venous blood glucose concentrations fall below 3.5mmol/L or if the subject experiences hypoglycaemia symptoms then hypoglycaemia will be confirmed by an additional venous blood plasma glucose sample and will be treated according to Imperial College Hospitals National Health Service Trust Guidelines.
After 25 hours of closed-loop, at 12:00 the next day, the subject's own insulin pump will be primed, reconnected and started as per the subject's usual insulin regime. Once running, the closed loop system will be disconnected. The subject can then eat and drink freely and may be discharged after 2 hours, or when glucose concentrations are stable.
The same protocol will be used when subjects cross over for the standard opened loop 25 hour study for the remaining visit.
Sub-study 3: Bi-hormonal closed-loop control during- and after mixed meals (n=20) A high fat/high carbohydrate content dinner (45g fat, 80g CHO) will be given at 19:00, a high glycaemic index breakfast (40g CHO) at 07:00 and a high protein/low carbohydrate lunch ( 30g protein,10g CHO) at 12:00.
Subjects will be free to gently mobilise around the clinical research unit, smoking will not be permitted. Subjects may drink unlimited water throughout the visit.
Real-time continuous glucose monitoring alarms will be set at 4mmol/L and 15mmol/L and will be audible by the subject and the research team.
The glucagon solution will be replaced with a freshly reconstituted glucagon solution every 8 hours throughout the closed-loop studies.
If the venous blood glucose concentrations fall below 3.5mmol/L or if the subject experiences hypoglycaemia symptoms then hypoglycaemia will be confirmed by an additional venous blood plasma glucose sample and will be treated according to Imperial College Hospitals National Health Service Trust Guidelines.
After 25 hours of closed-loop, at 18:00 the next day, the subject's own insulin pump will be primed, reconnected and started as per the subject's usual insulin regime. Once running, the closed-loop system will be disconnected. The subject can then eat and drink freely and may be discharged after 2 hours, or when glucose concentrations are stable.
The same protocol will be applied after cross over but with a standard opened loop insulin pump for the remaining visit.
- Conditions
- Type 1 Diabetes
- Being tested
- Bi-hormonal closed loop pump, Standard opened loop pump, Insulin closed loop
- Keywords
- Type 1 diabetes, Hypoglycaemia, Closed loop insulin pump, Artificial pancreas, Exercise, Mixed meals, Bihormonal pump
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bi-hormonal closed loop pumpDevice
Using a bio-inspired artificial pancreas consisting of a bi-hormonal closed loop pump
Standard opened loop pumpDevice
Using a standard opened loop pump
Insulin closed loopDevice
Using a closed loop
| Study group | Role | What they receive |
|---|---|---|
| Bihormonal closed loop | Experimental | Bi-hormonal closed loop pump will be used in the exercise and mixed meal substudies Receives: Device: Bi-hormonal closed loop pump |
| Standard opened loop pump | Active comparator | Standard opened loop pump will be used in the exercise and mixed meal substudies Receives: Device: Standard opened loop pump |
| Insulin only | Placebo comparator | Insulin only closed loop Receives: Device: Insulin closed loop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Time in Target Range Over 24 Hour
The primary outcome from the studies will be time spent with a glucose concentration in the target range (3.9-10.0mmol/l).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study start3 Dec 2014
- Primary completion22 Jul 2015
- Study completion22 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nick Oliver, MRCP, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397265
- Sponsor's protocol ID
- 14SM2107
- Status last verified
- Oct 2019
- First submitted
- 5 Mar 2015
- Last updated
- 1 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nathan D, Cleary P, Backlund J, Genuth S, Lachin J, Orchard T, Raskin R, Zinman B. Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes,
Buckingham B, Wilson DM, Lecher T, Hanas R, Kaiserman K, Cameron F. Duration of nocturnal hypoglycemia before seizures. Diabetes Care. 2008 Nov;31(11):2110-2. doi: 10.2337/dc08-0863. Epub 2008 Aug 11.
PubMed 18694975Sovik O, Thordarson H. Dead-in-bed syndrome in young diabetic patients. Diabetes Care. 1999 Mar;22 Suppl 2:B40-2.
PubMed 10097898Hovorka 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 21343892Cobelli C, Renard E, Kovatchev B. Artificial pancreas: past, present, future. Diabetes. 2011 Nov;60(11):2672-82. doi: 10.2337/db11-0654. No abstract available.
PubMed 22025773Ward WK, Massoud RG, Szybala CJ, Engle JM, El Youssef J, Carroll JM, Roberts CT Jr, DiMarchi RD. In vitro and in vivo evaluation of native glucagon and glucagon analog (MAR-D28) during aging: lack of cytotoxicity and preservation of hyperglycemic effect. J Diabetes Sci Technol. 2010 Nov 1;4(6):1311-21. doi: 10.1177/193229681000400604.
PubMed 21129325Oliver N, Georgiou P, Johnston D, Toumazou C. A benchtop closed-loop system controlled by a bio-inspired silicon implementation of the pancreatic beta cell. J Diabetes Sci Technol. 2009 Nov 1;3(6):1419-24. doi: 10.1177/193229680900300623.
PubMed 20144397Herrero P, Georgiou P, Oliver N, Johnston DG, Toumazou C. A bio-inspired glucose controller based on pancreatic beta-cell physiology. J Diabetes Sci Technol. 2012 May 1;6(3):606-16. doi: 10.1177/193229681200600316.
PubMed 22768892Herrero P, Georgiou P, Oliver N, Reddy M, Johnston D, Toumazou C. A composite model of glucagon-glucose dynamics for in silico testing of bihormonal glucose controllers. J Diabetes Sci Technol. 2013 Jul 1;7(4):941-51. doi: 10.1177/193229681300700416.
PubMed 23911175
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of a Closed-loop System With Glucagon, Exercise and Mixed Meals
- ClinicalTrials.gov ID
- NCT02397265
- Acronym / sponsor ID
- 14SM2107
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Hypoglycaemia, Closed loop insulin pump, Artificial pancreas, Exercise, Mixed meals, Bihormonal pump
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 3 Dec 2014 (actual)
- Primary completion
- 22 Jul 2015 (actual)
- Study completion
- 22 Jul 2015 (actual)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Posted 1 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The diabetes technology group at Imperial College have developed a bio-inspired artificial pancreas (BiAP) system which uses a control algorithm based on a mathematical model of beta-cell physiology. The algorithm is implemented on a miniature silicon microchip within a portable handheld device, which interfaces the components of the artificial pancreas.
Development of closed-loop insulin delivery devices to intensify control without hypoglycaemia has been extensively reviewed and have shown encouraging results . However, they have not yet proven to be robust when challenged with uncertainty and the external challenges (such as mixed meal contents, physical exercise, physiological stress and intercurrent illness) that people with Type 1 Diabetes Mellitus (T1DM) may be exposed to outside the clinical environment.
The principal research objective is to assess the safety and efficacy of a closed-loop system for T1DM compared to standard insulin pump therapy (open-loop). The primary outcome from the studies will be % time spent with a glucose concentration in the target range (3.9-10.0mmol/l). This outcome incorporates safety as it ensures subjects do not have low or high glucose excursions and is the principal measure of efficacy for closed-loop insulin delivery systems in the scientific literature. Other measured outcomes will be % time spent in euglycaemia (3.9-7.8mmol/l), % time spent in hypoglycaemia (<3.9mmol/l), % time spent in hyperglycaemia (>10mmol/l), mean venous blood and sensor glucose, glycaemic variability as measured by standard metrics (Standard Deviation, Continuous Overlapping Net Glycaemic Action, Lability Index, J-Index, Glycaemic Risk Assessment Diabetes Equation, Mean Of Daily Differences, Mean Amplitude of Glucose Excursion, Average Daily Risk Range, M-VALUE, Mean Average Glucose), glycaemic risk as measured by Low Blood Glucose Index (LBGI) and High Blood Glucose Index (HBGI), closed-loop error grid analysis, glucose area under the curve. All measures have been previously published and validated.
This clinical trial protocol assesses the artificial pancreas system in three separate sub-studies:
- In a bi-hormonal (insulin and glucagon) configuration
- During and after exercise with bi-hormonal closed loop, and standard insulin opened loop
- During and after meals of mixed composition with bi-hormonal closed loop, and standard insulin opened loop
Detailed description
Methodology Randomised controlled cross-over open label study
Sub study 1 (n=10)
In sub-study 1 which includes the first bio-inspired artificial pancreas study using bi-hormonal (insulin and glucagon) control a fasting 6-hour bi-hormonal closed-loop study will be conducted to assess proof of concept and safety prior to the 25-hour randomised controlled crossover study
Each subject will then be randomised to attend either a closed-loop visit or an open-loop visit first. Once either visit is completed each subject will crossover and attend the remaining visit.
Sub-study 2 (n=20) The aim of sub-study 2 is to challenge the bi-hormonal pump during a moderate exercise. Subjects will be initially randomised to either the bi-hormonal or the standard opened loop and then cross over. Each study will last for 25 hours
- Exercise protocol: Subjects will be connected to the gas analyser and heart rate/ECG monitor as per COSMED manufacturer instructions.
The oxygen consumption (VO2)/Carbon dioxide production (VCO2) and heart rate/ECG trace will be displayed continuously in real time while the subject is exercising.
Warm-up: 3 minutes of cycling at low resistance (20-30 watts) while maintaining a speed of 60-80 revolutions per minute After the warm-up the subjects will undergo a 30 minutes moderate intensity exercise session on the bike aiming to maintain their VO2 between 10-20% above their 1st ventilatory anaerobic threshold. If their VO2 falls below or goes above this level then the resistance will be increased or decreased accordingly. The target VO2 and the starting resistance (watts) will be individually set based on their baseline exercise test outcome.
The estimated time needed to complete the exercise test is 35-40 minutes.
Real-time continuous glucose monitoring alarms will be set at 4mmol/L and 15mmol/L and will be audible by the subject and the research team.
The glucagon solution will be replaced with a freshly reconstituted glucagon solution every 8 hours throughout the closed-loop study If the venous blood glucose concentrations fall below 3.5mmol/L or if the subject experiences hypoglycaemia symptoms then hypoglycaemia will be confirmed by an additional venous blood plasma glucose sample and will be treated according to Imperial College Hospitals National Health Service Trust Guidelines.
After 25 hours of closed-loop, at 12:00 the next day, the subject's own insulin pump will be primed, reconnected and started as per the subject's usual insulin regime. Once running, the closed loop system will be disconnected. The subject can then eat and drink freely and may be discharged after 2 hours, or when glucose concentrations are stable.
The same protocol will be used when subjects cross over for the standard opened loop 25 hour study for the remaining visit.
Sub-study 3: Bi-hormonal closed-loop control during- and after mixed meals (n=20) A high fat/high carbohydrate content dinner (45g fat, 80g CHO) will be given at 19:00, a high glycaemic index breakfast (40g CHO) at 07:00 and a high protein/low carbohydrate lunch ( 30g protein,10g CHO) at 12:00.
Subjects will be free to gently mobilise around the clinical research unit, smoking will not be permitted. Subjects may drink unlimited water throughout the visit.
Real-time continuous glucose monitoring alarms will be set at 4mmol/L and 15mmol/L and will be audible by the subject and the research team.
The glucagon solution will be replaced with a freshly reconstituted glucagon solution every 8 hours throughout the closed-loop studies.
If the venous blood glucose concentrations fall below 3.5mmol/L or if the subject experiences hypoglycaemia symptoms then hypoglycaemia will be confirmed by an additional venous blood plasma glucose sample and will be treated according to Imperial College Hospitals National Health Service Trust Guidelines.
After 25 hours of closed-loop, at 18:00 the next day, the subject's own insulin pump will be primed, reconnected and started as per the subject's usual insulin regime. Once running, the closed-loop system will be disconnected. The subject can then eat and drink freely and may be discharged after 2 hours, or when glucose concentrations are stable.
The same protocol will be applied after cross over but with a standard opened loop insulin pump for the remaining visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bihormonal closed loop | Experimental | Device: Bi-hormonal closed loop pumpBi-hormonal closed loop pump will be used in the exercise and mixed meal substudies |
| Standard opened loop pump | Active comparator | Device: Standard opened loop pumpStandard opened loop pump will be used in the exercise and mixed meal substudies |
| Insulin only | Placebo comparator | Device: Insulin closed loopInsulin only closed loop |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults over 18 years of age
- Type 1 diabetes confirmed on the basis of clinical features and a fasting c-peptide <200 pmol/L
- Type 1 diabetes for greater than 1 year
- Continuous subcutaneous insulin infusion for greater than 6 months
- HbA1c < 10% (86mmol/mol)
Key exclusion criteria (7 listed)
- Recurrent severe hypoglycaemia and hypoglycaemia unawareness
- Pregnant or planning pregnancy
- Breastfeeding
- Enrolled in other clinical trials
- Have active malignancy or under investigation for malignancy
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 |
|---|---|---|
| Bi-hormonal closed loop pumpUsing a bio-inspired artificial pancreas consisting of a bi-hormonal closed loop pump | Device | Bihormonal closed loop |
| Standard opened loop pumpUsing a standard opened loop pump | Device | Standard opened loop pump |
| Insulin closed loopUsing a closed loop | Device | Insulin only |
Primary outcome
Percentage of Time in Target Range Over 24 Hour
Time frame: 24 hours
The primary outcome from the studies will be time spent with a glucose concentration in the target range (3.9-10.0mmol/l).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundNathan D, Cleary P, Backlund J, Genuth S, Lachin J, Orchard T, Raskin R, Zinman B. Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes,
- Background: PubMed 18694975Buckingham B, Wilson DM, Lecher T, Hanas R, Kaiserman K, Cameron F. Duration of nocturnal hypoglycemia before seizures. Diabetes Care. 2008 Nov;31(11):2110-2. doi: 10.2337/dc08-0863. Epub 2008 Aug 11.
- Background: PubMed 10097898Sovik O, Thordarson H. Dead-in-bed syndrome in young diabetic patients. Diabetes Care. 1999 Mar;22 Suppl 2:B40-2.
- 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.
- Background: PubMed 22025773Cobelli C, Renard E, Kovatchev B. Artificial pancreas: past, present, future. Diabetes. 2011 Nov;60(11):2672-82. doi: 10.2337/db11-0654. No abstract available.
- Background: PubMed 21129325Ward WK, Massoud RG, Szybala CJ, Engle JM, El Youssef J, Carroll JM, Roberts CT Jr, DiMarchi RD. In vitro and in vivo evaluation of native glucagon and glucagon analog (MAR-D28) during aging: lack of cytotoxicity and preservation of hyperglycemic effect. J Diabetes Sci Technol. 2010 Nov 1;4(6):1311-21. doi: 10.1177/193229681000400604.
- Background: PubMed 20144397Oliver N, Georgiou P, Johnston D, Toumazou C. A benchtop closed-loop system controlled by a bio-inspired silicon implementation of the pancreatic beta cell. J Diabetes Sci Technol. 2009 Nov 1;3(6):1419-24. doi: 10.1177/193229680900300623.
- Background: PubMed 22768892Herrero P, Georgiou P, Oliver N, Johnston DG, Toumazou C. A bio-inspired glucose controller based on pancreatic beta-cell physiology. J Diabetes Sci Technol. 2012 May 1;6(3):606-16. doi: 10.1177/193229681200600316.
- Background: PubMed 23911175Herrero P, Georgiou P, Oliver N, Reddy M, Johnston D, Toumazou C. A composite model of glucagon-glucose dynamics for in silico testing of bihormonal glucose controllers. J Diabetes Sci Technol. 2013 Jul 1;7(4):941-51. doi: 10.1177/193229681300700416.
- Individual participant dataSharing planned: No
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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.
Nick Oliver, MRCP principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bi-hormonal closed loop pump, Standard opened loop pump and Insulin closed loop in people with Type 1 Diabetes, run by Imperial College London 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 5 inclusion and 7 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 1 Nov 2019. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 1 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Time in Target Range Over 24 Hour (time frame: 24 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 NCT02397265, which also lists 9 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 1 Nov 2019.