DysglycaemiaAngie01NCT01359241
Achieving Normal Glucose In Hospital Settings
A study testing closed-loop insulin delivery and Usual diabetes treatment regimen in people with Dysglycaemia, run by University of Cambridge at 1 site in United Kingdom.
Trial summary
The main objective of this study is to evaluate the efficacy and safety of 24 hours of closed-loop glucose control compared with standard diabetes treatment, in patients with type 2 diabetes treated by non-insulin glucose-lowering medications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysglycaemia
- What is being tested?
- closed-loop insulin delivery and Usual diabetes treatment regimen
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2011to Jul 2012
- 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
- Treatment with glucose-lowering medication(s) (including Exenatide) for at least 6 mths
- HbA1c between 7.0% and 10.0% inclusive (measured within past 3 mths)
Who cannot join
- Autoimmune type 1 diabetes
- Type 2 diabetes treated with insulin
- Type 2 diabetes treated with diet control alone
- Known or suspected allergy against insulin
- Proliferative retinopathy
- Current or planned pregnancy or breast feeding
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wellcome Trust Clinical Research Facility, Addenbrooke's Hospital
Cambridge, CB20QQ
About this study
Official title: An Open-label, Single-centre, Randomised, Two-period Crossover Study to Assess the Efficacy and Safety of 24-hour Closed-loop Glucose Control in Comparison With Conventional Treatment in Adults With Type 2 Diabetes on Non-insulin Glucose-lowering Agents
The main objective of this study is to evaluate the efficacy and safety of 24 hours of closed-loop glucose control compared with standard diabetes treatment, in patients with type 2 diabetes treated by non-insulin glucose-lowering medications. This group is being studied as it is representative of patients with glucose dysregulation.
Read the detailed description
Algorithm driven closed-loop enables automated subcutaneous delivery of insulin in response to real-time continuous glucose sensor readings. Our studies to date have assessed the safety and efficacy of closed-loop insulin delivery in patients with type 1 diabetes in a controlled setting. For patients with type 2 diabetes treated by diet or non-insulin glucose-lowering medications alone, an episode of acute illness may result in elevated glucose levels necessitating initiation of insulin replacement therapy to optimise glycaemic control. Insulin may also be required in patients with no prior history of diabetes, presenting with 'stress hyperglycaemia'. Closed-loop systems may be of benefit in such insulin-naive patients in whom the optimal dosing regimen is difficult to establish, and may provide a safer method of insulin delivery with the added benefit of continuous monitoring of glucose levels on general hospital wards, thus minimising the likelihood of hyper- and hypoglycaemic events and their known associated worse outcomes.
The study has an open-label, randomised, two-period crossover design. Participants will be randomised to undergo two 24-hour studies in a clinical research facility, during which glucose levels will be controlled by either the computer-based closed-loop algorithm (intervention) or by patients' usual non-insulin glucose-lowering diabetes treatment regimen (control). A continuous glucose sensor will be inserted on arrival for each visit. Participants will consume regular meals (matched on both visits) and carry out daily activities mimicking those occurring in an inpatient setting. Stable glucose isotopes will be administered on the two study occasions to collect data for modeling of glucose turnover around meals and during the overnight period.
- Conditions
- Dysglycaemia
- Being tested
- closed-loop insulin delivery, Usual diabetes treatment regimen
- Keywords
- dysglycemia, diabetes, closed loop insulin delivery
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closed-loop insulin deliveryProcedure or surgery
Insulin delivery via subcutaneous pump, adjusted according to computer-based algorithm advice, based on continuous glucose sensor readings
Usual diabetes treatment regimenDrug
Usual non-insulin glucose lowering medications
| Study group | Role | What they receive |
|---|---|---|
| closed-loop insulin delivery | Experimental | Subcutaneous insulin delivery adjusted according to computer-based algorithm advice, based on continuous glucose sensor readings Receives: Procedure: closed-loop insulin delivery |
| Usual diabetes treatment regimen | Active comparator | Usual non-insulin glucose-lowering medications Receives: Drug: Usual diabetes treatment regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of plasma glucose values within target range 3.9-8.0 mmol/l
Measured: 24 hrs
Secondary outcomes (13)
Percent of sensor glucose values within target range 3.9-8.0 mmol/l
Measured: 24 hrs
Percent of plasma and sensor glucose values below 3.9 mmol/l
Measured: 24 hrs
Percent of plasma and sensor glucose values above 8.0 mmol/l
Measured: 24 hrs
Mean plasma and sensor glucose
Measured: 24 hrs
Mean plasma insulin concentration
Measured: 24 hrs
Total basal insulin insulin delivery
Measured: 24 hrs
Low blood glucose index (LBGI) score
Measured: 24 hrs
High blood glucose index (HBGI) score
Measured: 24 hrs
Hyperglycaemic index score
Measured: 24 hrs
Percent of plasma and sensor glucose values below 3.0 mmol/l
Measured: 24 hrs
Standard deviation of plasma glucose
Measured: 24 hrs
Frequency of hypoglycaemia
Measured: 24 hrs
Frequency of hyperglycaemia
Measured: 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysglycaemiaStudies 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
- 16 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, Kavita Kumareswaran, University of Cambridge
- Investigators
- Roman Hovorka, PhD, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359241
- Sponsor's protocol ID
- A092232
- Acronym
- Angie01
- Status last verified
- Nov 2012
- First submitted
- 19 May 2011
- Last updated
- 12 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-centre, Randomised, Two-period Crossover Study to Assess the Efficacy and Safety of 24-hour Closed-loop Glucose Control in Comparison With Conventional Treatment in Adults With Type 2 Diabetes on Non-insulin Glucose-lowering Agents
- ClinicalTrials.gov ID
- NCT01359241
- Acronym / sponsor ID
- Angie01 / A092232
- Conditions
- Dysglycaemia
- Keywords
- dysglycemia, diabetes, closed loop insulin delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Study start
- Nov 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 24 May 2011 (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 evaluate the efficacy and safety of 24 hours of closed-loop glucose control compared with standard diabetes treatment, in patients with type 2 diabetes treated by non-insulin glucose-lowering medications. This group is being studied as it is representative of patients with glucose dysregulation.
Detailed description
Algorithm driven closed-loop enables automated subcutaneous delivery of insulin in response to real-time continuous glucose sensor readings. Our studies to date have assessed the safety and efficacy of closed-loop insulin delivery in patients with type 1 diabetes in a controlled setting. For patients with type 2 diabetes treated by diet or non-insulin glucose-lowering medications alone, an episode of acute illness may result in elevated glucose levels necessitating initiation of insulin replacement therapy to optimise glycaemic control. Insulin may also be required in patients with no prior history of diabetes, presenting with 'stress hyperglycaemia'. Closed-loop systems may be of benefit in such insulin-naive patients in whom the optimal dosing regimen is difficult to establish, and may provide a safer method of insulin delivery with the added benefit of continuous monitoring of glucose levels on general hospital wards, thus minimising the likelihood of hyper- and hypoglycaemic events and their known associated worse outcomes.
The study has an open-label, randomised, two-period crossover design. Participants will be randomised to undergo two 24-hour studies in a clinical research facility, during which glucose levels will be controlled by either the computer-based closed-loop algorithm (intervention) or by patients' usual non-insulin glucose-lowering diabetes treatment regimen (control). A continuous glucose sensor will be inserted on arrival for each visit. Participants will consume regular meals (matched on both visits) and carry out daily activities mimicking those occurring in an inpatient setting. Stable glucose isotopes will be administered on the two study occasions to collect data for modeling of glucose turnover around meals and during the overnight period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| closed-loop insulin delivery | Experimental | Procedure: closed-loop insulin deliverySubcutaneous insulin delivery adjusted according to computer-based algorithm advice, based on continuous glucose sensor readings |
| Usual diabetes treatment regimen | Active comparator | Drug: Usual diabetes treatment regimenUsual non-insulin glucose-lowering medications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years or older
- Type 2 diabetes for at least 1 year as defined by WHO
- Treatment with glucose-lowering medication(s) (including Exenatide) for at least 6 mths
- HbA1c between 7.0% and 10.0% inclusive (measured within past 3 mths)
Key exclusion criteria (7 listed)
- Autoimmune type 1 diabetes
- Type 2 diabetes treated with insulin
- Type 2 diabetes treated with diet control alone
- Known or suspected allergy against insulin
- Proliferative retinopathy
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 insulin deliveryInsulin delivery via subcutaneous pump, adjusted according to computer-based algorithm advice, based on continuous glucose sensor readings | Procedure or surgery | closed-loop insulin delivery |
| Usual diabetes treatment regimenUsual non-insulin glucose lowering medications | Drug | Usual diabetes treatment regimen |
Primary outcome
Percent of plasma glucose values within target range 3.9-8.0 mmol/l
Time frame: 24 hrs
13 secondary outcomes
Percent of sensor glucose values within target range 3.9-8.0 mmol/l
Time frame: 24 hrs
Percent of plasma and sensor glucose values below 3.9 mmol/l
Time frame: 24 hrs
Percent of plasma and sensor glucose values above 8.0 mmol/l
Time frame: 24 hrs
Mean plasma and sensor glucose
Time frame: 24 hrs
Mean plasma insulin concentration
Time frame: 24 hrs
Total basal insulin insulin delivery
Time frame: 24 hrs
Low blood glucose index (LBGI) score
Time frame: 24 hrs
High blood glucose index (HBGI) score
Time frame: 24 hrs
Hyperglycaemic index score
Time frame: 24 hrs
Percent of plasma and sensor glucose values below 3.0 mmol/l
Time frame: 24 hrs
Standard deviation of plasma glucose
Time frame: 24 hrs
Frequency of hypoglycaemia
Time frame: 24 hrs
Frequency of hyperglycaemia
Time frame: 24 hrs
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 12 Nov 2012.
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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
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 insulin delivery and Usual diabetes treatment regimen in people with Dysglycaemia, 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 4 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 12 Nov 2012. 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?
Percent of plasma glucose values within target range 3.9-8.0 mmol/l (time frame: 24 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2012.