Diabetes MellitusANGIE02NCT01774565
Closed-loop Insulin Delivery in the General Ward
A study testing Fully Automated Closed-Loop Insulin Delivery and Conventional insulin therapy in people with Diabetes Mellitus, run by University of Cambridge at 2 sites in 2 countries.
Trial summary
The study assesses the efficacy and safety of closed-loop glucose control in patients with insulin-treated type 2 diabetes. Phase 1 The study objective is to compare conventional insulin therapy with closed-loop glucose control combined with once daily basal insulin injection over 72 hours in hospitalised insulin… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Fully Automated Closed-Loop Insulin Delivery and Conventional insulin therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2016to 21 Sep 2018
- 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
- Aged 18 years or older
- Type 2 Diabetes for at least 1 year as defined by WHO (phase 1 and 4)
- Inpatient hyperglycaemia requiring subcutaneous insulin therapy (phase 2 and 3)
- Treatment with subcutaneous insulin alone or in combination with oral glucose-lowering medication(s) (phase 4: basal bolus insulin regime for at least 3 months)
- Receiving parenteral and/or enteral nutrition (phase 3)
- HbA1c<11.0% (phase 4)
Who cannot join
- Autoimmune type 1 diabetes
- Known or suspected allergy against insulin
- Known proliferative retinopathy
- Current or planned pregnancy or breast feeding
- Unstable or end-stage cardiac and renal disease (phase 1 only)
- Planned surgery during study period (phase 1 only)
Show all 9Show fewer
- Current in-patient in intensive care unit
- Any physical or psychological disease or medication(s) likely to interfere with the conduct of the study and interpretation of the study results, as judged by the study clinician
- Likely discharge earlier than 72 hours (phase 1 only)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Switzerland1 site
Inselspital, Bern University Hospital, University of Bern, Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism
Bern, 3010
United Kingdom1 site
Cambridge University Hospitals NHS Foundation Trust
Cambridge
About this study
Official title: A Randomised Study to Assess the Efficacy and Safety of Automated Closed-loop Glucose Control in Insulin Treated Type 2 Diabetes (Phase 1), Inpatient Hyperglycaemia Requiring Subcutaneous Insulin Therapy (Phase 2 and Phase 3) and to Evaluate Use of Closed-loop Applying Faster Insulin Aspart Versus Standard Insulin Aspart (Phase 4)
The study assesses the efficacy and safety of closed-loop glucose control in patients with insulin-treated type 2 diabetes.
Phase 1 The study objective is to compare conventional insulin therapy with closed-loop glucose control combined with once daily basal insulin injection over 72 hours in hospitalised insulin treated T2D subjects.
Read more
Phase 2 The study objective is to compare conventional insulin therapy with closed-loop glucose control up to maximum 15 days in hospitalised insulin treated T2D subjects.
Phase 3 The study objective is to compare conventional insulin therapy with closed-loop glucose control applying faster insulin aspart up to maximum 15 days in insulin-treated inpatients receiving parenteral and/or enteral nutrition.
Phase 4 The study objective is to compare automated closed-loop control using faster acting insulin aspart with closed-loop control using standard insulin aspart.
Read the detailed description
Hyperglycaemia in hospitalized patients is becoming a common clinical problem due to the increasing prevalence of diabetes mellitus . Hyperglycaemia in this cohort can also occur in patients with previously undiagnosed diabetes, or during acute illness in those with previously normal glucose tolerance. As a result, the prevalence of acute or stress hyperglycaemia in hospitalised patients has been widely reported. A growing body of evidence currently suggest that the degree of hyperglycaemia upon admission and the duration of hyperglycaemia during their illness are associated with adverse outcomes.In-patient hyperglycaemia is now widely recognised as a poor prognostic marker in terms of morbidity and mortality, increased length of stay and cost to the healthcare system.
The current management of in-patient hyperglycaemia in non-critical care is still far from ideal, and vary widely between different centres. The discordance between clinical evidence and practice is due to a number of factors which could potentially undermine patient care and safety. Of these, hypoglycaemia remains one the biggest barriers to managing in-patient hyperglycaemia. There is therefore a need to develop and validate a more effective and safer system to manage in-patient hyperglycaemia.
A closed-loop insulin infusion system has previously been tested and reported to be feasible and safe in intensive care patients. Its utilisation in non-critical patients in the general medical and surgical wards currently remains unproven. Its use in this cohort however could potentially be of significant practical and clinical value, especially in a busy ward environment. The Model Predictive Control (MPC) algorithm developed by our group at the University of Cambridge utilises fundamental glucoregulatory processes and predicts future glucose excursion resulting from projected insulin infusion rates. The algorithm can also account for the patient's meal intake and the duration of action of the short acting insulin used. This has the distinct advantage over the "reactive" approach of sliding scale insulin protocols, which treats hyperglycaemia after it has already occurred.
The MPC algorithm has been studied in intensive care and cardiac surgery patients, and results from these studies to date have been encouraging. It is shown to be associated with a significantly higher percentage of time within the blood glucose target range, without increasing the risk of severe hypoglycaemia. The expectant role of a closed-loop system using the MPC algorithm in non-critical care patients would therefore be to provide clinicians with an effective and safe method to manage hyperglycaemia in hospital.
In early 2017, faster-acting insulin aspart (Fiasp, Novo Nordisk, Copenhagen, Denmark) received marketing authorisation from the European Commission. Due to the more favourable pharmacokinetic profile, Fiasp has the potential to further improve safety and efficacy of fully automated closed-loop glucose control.
- Conditions
- Diabetes Mellitus
- Being tested
- Fully Automated Closed-Loop Insulin Delivery, Conventional insulin therapy
- Keywords
- Diabetes, Insulin, Closed-Loop, Real-time CGM, Subcutaneous insulin pump, Hospital
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fully Automated Closed-Loop Insulin DeliveryDevice
Conventional insulin therapyDevice
| Study group | Role | What they receive |
|---|---|---|
| Fully Automated Closed-Loop Insulin Delivery (phase 1-4) | Experimental | The control algorithm will automatically direct between meals and meal-related subcutaneous insulin delivery utilizing real-time continuous glucose monitoring (RT-CGM) data. The subcutaneous insulin pump will deliver insulin Aspart or similar. In phase 1, a once daily basal insulin analogue will also be given subcutaneously at 20% the patient's usual total daily dose. In phase 3 and 4 faster-acting insulin aspart (Fiasp) is applied. Receives: Device: Fully Automated Closed-Loop Insulin Delivery |
| Usual care/ fully-automated closed-loop using Iasp | Active comparator | Phase 1-3: During usual care (conventional therapy), subject's s.c. insulin dose and regimen on admission will be adjusted as necessary by the clinical team according to local centres' usual clinical practice. Subjects will have masked CGM sensors inserted during the study (CGM readings will be masked throughout the study).
Phase 4: subjects will receive fully-automated insulin delivery using standard insulin aspart (Iasp) Receives: Device: Conventional insulin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent in target glucose range (5.6-10.0mmol/l)
Primary outcome will be measured using continuous subcutaneous glucose monitoring (CGM) data (Phase 1-3) and plasma (Phase 4).
Measured: Phase 1 (Pilot study) = 72-hours, Phase 2 (Follow-up study) = Up to 15 days
Secondary outcomes (13)
Proportion of time with glucose levels below 5.6 mmol/l and above 10.0 mmol/l as recorded by CGM
CGM (Phase 1-4) and plasma glucose (Phase4)
Measured: Phase 1 (Pilot study) = 72-hours, Phase 2 and Phase 3 (Follow-up study)= Up to 15 days, Phase 4=between 07:00 and 17:00
Average glucose levels, as recorded by CGM
CGM (Phase 1-4) and plasma glucose (Phase4)
Measured: Phase 1 (Pilot study) = 72-hours, Phase 2 and Phase 3 (Follow-up study)= Up to 15 days, Phase 4=between 07:00 and 17:00
Proportion of time with glucose levels below 3.9 mmol/l as recorded by CGM
CGM (Phase 1-4) and plasma glucose (Phase4)
Measured: Phase 1 (Pilot study) = 72-hours, Phase 2 and Phase 3 (Follow-up study)= Up to 15 days, Phase 4=between 07:00 and 17:00
Proportion of time with glucose levels below 3.0 mmol/l as recorded by CGM
CGM (Phase 1-4) and plasma glucose (Phase4)
Measured: Phase 2 and Phase 3 (Follow-up study)= Up to 15 days, Phase 4= over 10 hours
Proportion of time with glucose levels below 2.8 mmol/l as recorded by CGM
CGM (Phase 1-4) and plasma glucose (Phase4)
Measured: Phase 2 and Phase 3 (Follow-up study)= Up to 15 days, Phase 4= over 10 hours
Area under the curve of sensor glucose levels below 3.5 mmol/l as recorded by CGM
CGM (Phase 1-4) and plasma glucose (Phase4)
Measured: Phase 1 (Pilot study) = 72-hours, Phase 2-3 (Follow-up study) = Up to 15 days, Phase 4= over 10 hours
Area under the curve of sensor glucose levels below 3.0 mmol/l as recorded by CGM
CGM (Phase 1-4) and plasma glucose (Phase4)
Measured: Phase 2-3 (Follow-up study) = Up to 15 days, Phase 4= over 10 hours
Standard deviation and coefficient of variation of glucose levels, as recorded by CGM
CGM (Phase 1-4) and plasma glucose (Phase4)
Measured: Phase 1 (Pilot study) = 72-hours, Phase 2-3 (Follow-up study) = Up to 15 days, Phase 4= over 10 hours
Proportion of time with glucose levels in significant hyperglycaemic range (>20mmol/l) as recorded by CGM
CGM (Phase 1-4) and plasma glucose (Phase4)
Measured: Phase 2-3 (Follow-up study) = Up to 15 days, Phase 4= over 10 hours
Total daily insulin dose
Measured: Phase 2-3 (Follow-up study) = Up to 15 days, Phase 4= over 10 hours
Between 24 hour period variability
Coefficient of variation of CGM glucose between 24 hour periods (08:00 to 08:00) (Phase 1-3)
Measured: Phase 2-3 (Follow-up study) = Up to 15 days, Phase 4= over 10 hours
Number of capillary glucose confirmed hypoglycaemic events <3.5mmol/l
Capillary glucose measurements will be performed using hospital point of care devices
Measured: Phase 2-3 (Follow-up study) = Up to 15 days, Phase 4= over 10 hours
Pre-breakfast, pre-lunch, pre-dinner, and evening capillary glucose values
Capillary glucose measurements will be performed using hospital point of care devices (Phase 1-3)
Measured: Phase 2-3 (Follow-up study) = Up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startAug 2016
- Primary completion21 Sep 2018
- Study completion21 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Parallel groups
- Model description
- Randomised parallel (phase 1-3) and randomised crossover (phase 4)
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, Insel Gruppe AG, University Hospital Bern
- Responsible party
- Principal investigator, Hood Thabit, University of Cambridge
- Investigators
- Roman Hovorka, PhD, MSc, BSc, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774565
- Sponsor's protocol ID
- ANGIE02
- Other IDs
- A092763
- Acronym
- ANGIE02
- Status last verified
- Oct 2018
- First submitted
- 18 Jan 2013
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bally L, Gubler P, Thabit H, Hartnell S, Ruan Y, Wilinska ME, Evans ML, Semmo M, Vogt B, Coll AP, Stettler C, Hovorka R. Fully closed-loop insulin delivery improves glucose control of inpatients with type 2 diabetes receiving hemodialysis. Kidney Int. 2019 Sep;96(3):593-596. doi: 10.1016/j.kint.2019.03.006. Epub 2019 Mar 20.
PubMed 31133457Boughton CK, Bally L, Martignoni F, Hartnell S, Herzig D, Vogt A, Wertli MM, Wilinska ME, Evans ML, Coll AP, Stettler C, Hovorka R. Fully closed-loop insulin delivery in inpatients receiving nutritional support: a two-centre, open-label, randomised controlled trial. Lancet Diabetes Endocrinol. 2019 May;7(5):368-377. doi: 10.1016/S2213-8587(19)30061-0. Epub 2019 Mar 29.
PubMed 30935872Bally L, Thabit H, Hartnell S, Andereggen E, Ruan Y, Wilinska ME, Evans ML, Wertli MM, Coll AP, Stettler C, Hovorka R. Closed-Loop Insulin Delivery for Glycemic Control in Noncritical Care. N Engl J Med. 2018 Aug 9;379(6):547-556. doi: 10.1056/NEJMoa1805233. Epub 2018 Jun 25.
PubMed 29940126Thabit H, Hartnell S, Allen JM, Lake A, Wilinska ME, Ruan Y, Evans ML, Coll AP, Hovorka R. Closed-loop insulin delivery in inpatients with type 2 diabetes: a randomised, parallel-group trial. Lancet Diabetes Endocrinol. 2017 Feb;5(2):117-124. doi: 10.1016/S2213-8587(16)30280-7. Epub 2016 Nov 9.
PubMed 27836235
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Study to Assess the Efficacy and Safety of Automated Closed-loop Glucose Control in Insulin Treated Type 2 Diabetes (Phase 1), Inpatient Hyperglycaemia Requiring Subcutaneous Insulin Therapy (Phase 2 and Phase 3) and to Evaluate Use of Closed-loop Applying Faster Insulin Aspart Versus Standard Insulin Aspart (Phase 4)
- ClinicalTrials.gov ID
- NCT01774565
- Acronym / sponsor ID
- ANGIE02 / ANGIE02
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes, Insulin, Closed-Loop, Real-time CGM, Subcutaneous insulin pump, Hospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, Insel Gruppe AG, University Hospital Bern
- Study start
- Aug 2016 (actual)
- Primary completion
- 21 Sep 2018 (actual)
- Study completion
- 21 Sep 2018 (actual)
- First posted
- 24 Jan 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 study assesses the efficacy and safety of closed-loop glucose control in patients with insulin-treated type 2 diabetes.
Phase 1 The study objective is to compare conventional insulin therapy with closed-loop glucose control combined with once daily basal insulin injection over 72 hours in hospitalised insulin treated T2D subjects.
Phase 2 The study objective is to compare conventional insulin therapy with closed-loop glucose control up to maximum 15 days in hospitalised insulin treated T2D subjects.
Phase 3 The study objective is to compare conventional insulin therapy with closed-loop glucose control applying faster insulin aspart up to maximum 15 days in insulin-treated inpatients receiving parenteral and/or enteral nutrition.
Phase 4 The study objective is to compare automated closed-loop control using faster acting insulin aspart with closed-loop control using standard insulin aspart.
Detailed description
Hyperglycaemia in hospitalized patients is becoming a common clinical problem due to the increasing prevalence of diabetes mellitus . Hyperglycaemia in this cohort can also occur in patients with previously undiagnosed diabetes, or during acute illness in those with previously normal glucose tolerance. As a result, the prevalence of acute or stress hyperglycaemia in hospitalised patients has been widely reported. A growing body of evidence currently suggest that the degree of hyperglycaemia upon admission and the duration of hyperglycaemia during their illness are associated with adverse outcomes.In-patient hyperglycaemia is now widely recognised as a poor prognostic marker in terms of morbidity and mortality, increased length of stay and cost to the healthcare system.
The current management of in-patient hyperglycaemia in non-critical care is still far from ideal, and vary widely between different centres. The discordance between clinical evidence and practice is due to a number of factors which could potentially undermine patient care and safety. Of these, hypoglycaemia remains one the biggest barriers to managing in-patient hyperglycaemia. There is therefore a need to develop and validate a more effective and safer system to manage in-patient hyperglycaemia.
A closed-loop insulin infusion system has previously been tested and reported to be feasible and safe in intensive care patients. Its utilisation in non-critical patients in the general medical and surgical wards currently remains unproven. Its use in this cohort however could potentially be of significant practical and clinical value, especially in a busy ward environment. The Model Predictive Control (MPC) algorithm developed by our group at the University of Cambridge utilises fundamental glucoregulatory processes and predicts future glucose excursion resulting from projected insulin infusion rates. The algorithm can also account for the patient's meal intake and the duration of action of the short acting insulin used. This has the distinct advantage over the "reactive" approach of sliding scale insulin protocols, which treats hyperglycaemia after it has already occurred.
The MPC algorithm has been studied in intensive care and cardiac surgery patients, and results from these studies to date have been encouraging. It is shown to be associated with a significantly higher percentage of time within the blood glucose target range, without increasing the risk of severe hypoglycaemia. The expectant role of a closed-loop system using the MPC algorithm in non-critical care patients would therefore be to provide clinicians with an effective and safe method to manage hyperglycaemia in hospital.
In early 2017, faster-acting insulin aspart (Fiasp, Novo Nordisk, Copenhagen, Denmark) received marketing authorisation from the European Commission. Due to the more favourable pharmacokinetic profile, Fiasp has the potential to further improve safety and efficacy of fully automated closed-loop glucose control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised parallel (phase 1-3) and randomised crossover (phase 4)
| Arm | Type | Receives |
|---|---|---|
| Fully Automated Closed-Loop Insulin Delivery (phase 1-4) | Experimental | Device: Fully Automated Closed-Loop Insulin DeliveryThe control algorithm will automatically direct between meals and meal-related subcutaneous insulin delivery utilizing real-time continuous glucose monitoring (RT-CGM) data. The subcutaneous insulin pump will deliver insulin Aspart or similar. In phase 1, a once daily basal insulin analogue will also be given subcutaneously at 20% the patient's usual total daily dose. In phase 3 and 4 faster-acting insulin aspart (Fiasp) is applied. |
| Usual care/ fully-automated closed-loop using Iasp | Active comparator | Device: Conventional insulin therapyPhase 1-3: During usual care (conventional therapy), subject's s.c. insulin dose and regimen on admission will be adjusted as necessary by the clinical team according to local centres' usual clinical practice. Subjects will have masked CGM sensors inserted during the study (CGM readings will be masked throughout the study). Phase 4: subjects will receive fully-automated insulin delivery using standard insulin aspart (Iasp) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years or older
- Type 2 Diabetes for at least 1 year as defined by WHO (phase 1 and 4)
- Inpatient hyperglycaemia requiring subcutaneous insulin therapy (phase 2 and 3)
- Treatment with subcutaneous insulin alone or in combination with oral glucose-lowering medication(s) (phase 4: basal bolus insulin regime for at least 3 months)
- Receiving parenteral and/or enteral nutrition (phase 3)
Key exclusion criteria (9 listed)
- Autoimmune type 1 diabetes
- Known or suspected allergy against insulin
- Known proliferative retinopathy
- Current or planned pregnancy or breast feeding
- Unstable or end-stage cardiac and renal disease (phase 1 only)
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 |
|---|---|---|
| Fully Automated Closed-Loop Insulin Delivery | Device | Fully Automated Closed-Loop Insulin Delivery (phase 1-4) |
| Conventional insulin therapy | Device | Usual care/ fully-automated closed-loop using Iasp |
Primary outcome
Time spent in target glucose range (5.6-10.0mmol/l)
Time frame: Phase 1 (Pilot study) = 72-hours, Phase 2 (Follow-up study) = Up to 15 days
Primary outcome will be measured using continuous subcutaneous glucose monitoring (CGM) data (Phase 1-3) and plasma (Phase 4).
13 secondary outcomes
Proportion of time with glucose levels below 5.6 mmol/l and above 10.0 mmol/l as recorded by CGM
Time frame: Phase 1 (Pilot study) = 72-hours, Phase 2 and Phase 3 (Follow-up study)= Up to 15 days, Phase 4=between 07:00 and 17:00
Average glucose levels, as recorded by CGM
Time frame: Phase 1 (Pilot study) = 72-hours, Phase 2 and Phase 3 (Follow-up study)= Up to 15 days, Phase 4=between 07:00 and 17:00
Proportion of time with glucose levels below 3.9 mmol/l as recorded by CGM
Time frame: Phase 1 (Pilot study) = 72-hours, Phase 2 and Phase 3 (Follow-up study)= Up to 15 days, Phase 4=between 07:00 and 17:00
Proportion of time with glucose levels below 3.0 mmol/l as recorded by CGM
Time frame: Phase 2 and Phase 3 (Follow-up study)= Up to 15 days, Phase 4= over 10 hours
Proportion of time with glucose levels below 2.8 mmol/l as recorded by CGM
Time frame: Phase 2 and Phase 3 (Follow-up study)= Up to 15 days, Phase 4= over 10 hours
Area under the curve of sensor glucose levels below 3.5 mmol/l as recorded by CGM
Time frame: Phase 1 (Pilot study) = 72-hours, Phase 2-3 (Follow-up study) = Up to 15 days, Phase 4= over 10 hours
Area under the curve of sensor glucose levels below 3.0 mmol/l as recorded by CGM
Time frame: Phase 2-3 (Follow-up study) = Up to 15 days, Phase 4= over 10 hours
Standard deviation and coefficient of variation of glucose levels, as recorded by CGM
Time frame: Phase 1 (Pilot study) = 72-hours, Phase 2-3 (Follow-up study) = Up to 15 days, Phase 4= over 10 hours
Proportion of time with glucose levels in significant hyperglycaemic range (>20mmol/l) as recorded by CGM
Time frame: Phase 2-3 (Follow-up study) = Up to 15 days, Phase 4= over 10 hours
Total daily insulin dose
Time frame: Phase 2-3 (Follow-up study) = Up to 15 days, Phase 4= over 10 hours
Between 24 hour period variability
Time frame: Phase 2-3 (Follow-up study) = Up to 15 days, Phase 4= over 10 hours
Number of capillary glucose confirmed hypoglycaemic events <3.5mmol/l
Time frame: Phase 2-3 (Follow-up study) = Up to 15 days, Phase 4= over 10 hours
Pre-breakfast, pre-lunch, pre-dinner, and evening capillary glucose values
Time frame: Phase 2-3 (Follow-up study) = Up to 15 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 19 Oct 2018.
- Derived from this study: PubMed 31133457Bally L, Gubler P, Thabit H, Hartnell S, Ruan Y, Wilinska ME, Evans ML, Semmo M, Vogt B, Coll AP, Stettler C, Hovorka R. Fully closed-loop insulin delivery improves glucose control of inpatients with type 2 diabetes receiving hemodialysis. Kidney Int. 2019 Sep;96(3):593-596. doi: 10.1016/j.kint.2019.03.006. Epub 2019 Mar 20.
- Derived from this study: PubMed 30935872Boughton CK, Bally L, Martignoni F, Hartnell S, Herzig D, Vogt A, Wertli MM, Wilinska ME, Evans ML, Coll AP, Stettler C, Hovorka R. Fully closed-loop insulin delivery in inpatients receiving nutritional support: a two-centre, open-label, randomised controlled trial. Lancet Diabetes Endocrinol. 2019 May;7(5):368-377. doi: 10.1016/S2213-8587(19)30061-0. Epub 2019 Mar 29.
- Derived from this study: PubMed 29940126Bally L, Thabit H, Hartnell S, Andereggen E, Ruan Y, Wilinska ME, Evans ML, Wertli MM, Coll AP, Stettler C, Hovorka R. Closed-Loop Insulin Delivery for Glycemic Control in Noncritical Care. N Engl J Med. 2018 Aug 9;379(6):547-556. doi: 10.1056/NEJMoa1805233. Epub 2018 Jun 25.
- Derived from this study: PubMed 27836235Thabit H, Hartnell S, Allen JM, Lake A, Wilinska ME, Ruan Y, Evans ML, Coll AP, Hovorka R. Closed-loop insulin delivery in inpatients with type 2 diabetes: a randomised, parallel-group trial. Lancet Diabetes Endocrinol. 2017 Feb;5(2):117-124. doi: 10.1016/S2213-8587(16)30280-7. Epub 2016 Nov 9.
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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, MSc, BSc principal investigator
University of Cambridge
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fully Automated Closed-Loop Insulin Delivery and Conventional insulin therapy in people with Diabetes Mellitus, run by University of Cambridge at 2 sites in 2 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 6 inclusion and 9 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 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland, 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 target glucose range (5.6-10.0mmol/l) (time frame: Phase 1 (Pilot study) = 72-hours, Phase 2 (Follow-up study) = Up to 15 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 NCT01774565, which also lists 4 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 19 Oct 2018; AzTrials last refreshed its copy on 29 Oct 2026.