Type 1 DiabetesANGELA02NCT00944619
Closing the Loop in Adults With Type 1 Diabetes - Alcohol Consumption
A study testing Closed loop and Conventional insulin pump delivery in people with Type 1 Diabetes, run by University of Cambridge at 1 site in United Kingdom.
Trial summary
The main objective is to assess the efficacy and safety of overnight automated closed loop glucose control using a computer-based algorithm compared with conventional insulin pump therapy in adults with type 1 diabetes following the consumption of a moderate amount of alcohol at dinnertime. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Closed loop and Conventional insulin pump delivery
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2009to Dec 2009
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes, as defined by WHO for at least 6 months or confirmed C-peptide negative
- On insulin pump therapy for at least 3 months
Who cannot join
- Non-type 1 diabetes mellitus
- Any physical/psychological disease likely to interfere with the study
- Taking medication likely to interfere with interpretation of results
- Known/suspected allergy against insulin
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator
- Unstable blood glucose control, including recurrent severe hypoglycaemia as judged by the investigator
Show all 10Show fewer
- Current pregnancy/breastfeeding
- Total daily insulin dose > 1.4 IU/kg
- HbA1C > 10% within the last 3 months
- Unable/unwilling to consume the necessary quantity of alcohol stated in the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised, Two-Period Crossover Study to Assess the Efficacy of Overnight Computer-based Glucose Control Compared With Conventional Pump Therapy Following the Consumption of Alcohol in Adults With Type 1 Diabetes
The main objective is to assess the efficacy and safety of overnight automated closed loop glucose control using a computer-based algorithm compared with conventional insulin pump therapy in adults with type 1 diabetes following the consumption of a moderate amount of alcohol at dinnertime.
Read the detailed description
People with type 1 diabetes need regular insulin injections or continuous delivery of insulin using an insulin pump. Keeping blood sugars in the normal range is known to reduce the risk of long term complications involving the eyes, kidneys and heart. However, achieving treatment goals can be very difficult as the tighter we try to control blood glucose levels, the greater the risk of the person developing episodes of low glucose levels (hypoglycaemia). One solution is using a system where the amount of insulin injected closely matches the blood sugar levels on a continuous basis. This can be achieved by what is known as a "closed loop system" where a small glucose sensor placed under the skin communicates with a computer containing an algorithm that drives a subcutaneous insulin pump. This system is being developed in Cambridge and is undergoing trials in children and adults with type 1 diabetes. Results thus far show that the system is very effective at preventing hypoglycaemia and maintaining blood glucose levels in target range.
We plan to test the closed loop in various challenging conditions faced by patients in daily life. One of these is the consumption of alcohol, which can give rise to delayed hypoglycaemia in patients with diabetes. The studies will be done in a clinical research facility under supervised conditions. Subjects will attend for two study nights where they will receive a specific volume of alcohol with an evening meal. On one night this will be followed by closed loop algorithm control of their insulin overnight. On the other (control) night subjects will remain on their usual pump therapy regime overnight.
- Conditions
- Type 1 Diabetes
- Being tested
- Closed loop, Conventional insulin pump delivery
- 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.
Closed loopDevice
Subcutaneous delivery of Novorapid insulin, dose calculated by control algorithm, based on continuous glucose sensor readings
Conventional insulin pump deliveryDevice
Subcutaneous delivery of Novorapid insulin according to usual pump regime
| Study group | Role | What they receive |
|---|---|---|
| Closed loop (algorithm) | Experimental | Subcutaneous delivery of Novorapid insulin, dose calculated by computer-driven control algorithm, based on continuous glucose sensor readings Receives: Device: Closed loop |
| Open loop | Placebo comparator | Subcutaneous delivery of Novorapid insulin according to usual pump regime Receives: Device: Conventional insulin pump delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of plasma glucose values in target (3.9-8.0 mmol/L)
Measured: 2200-1200hr
Secondary outcomes (10)
Percentage of CGM (continuous glucose monitoring) values in target (3.9-8.0 mmol/L)
Measured: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
Percentage of plasma glucose and CGM values in target (3.9-8.0 mmol/L)
Measured: 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
Percentage of plasma glucose and CGM values below 3.9 mmol/L
Measured: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
Percentage of plasma glucose and CGM values above 8.0 mmol/L
Measured: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
Average plasma and CGM glucose
Measured: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
Average plasma insulin concentration
Measured: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
Total dose of insulin administered
Measured: 2200-1200hrs
Low blood glucose index (LBGI) score
Measured: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
High blood glucose index (HBGI) score
Measured: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
Percentage of plasma glucose and CGM values below 3.0 mmol/L
Measured: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Mark L Evans, MD FRCP, Principal investigator, University of Cambridge, UKRoman Hovorka, PhD, Study director, University of Cambridge, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944619
- Sponsor's protocol ID
- 09/H0306/44
- Acronym
- ANGELA02
- Status last verified
- Jan 2010
- First submitted
- 21 Jul 2009
- Last updated
- 12 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Hovorka 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 21493665
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Two-Period Crossover Study to Assess the Efficacy of Overnight Computer-based Glucose Control Compared With Conventional Pump Therapy Following the Consumption of Alcohol in Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00944619
- Acronym / sponsor ID
- ANGELA02 / 09/H0306/44
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 23 Jul 2009 (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 is to assess the efficacy and safety of overnight automated closed loop glucose control using a computer-based algorithm compared with conventional insulin pump therapy in adults with type 1 diabetes following the consumption of a moderate amount of alcohol at dinnertime.
Detailed description
People with type 1 diabetes need regular insulin injections or continuous delivery of insulin using an insulin pump. Keeping blood sugars in the normal range is known to reduce the risk of long term complications involving the eyes, kidneys and heart. However, achieving treatment goals can be very difficult as the tighter we try to control blood glucose levels, the greater the risk of the person developing episodes of low glucose levels (hypoglycaemia). One solution is using a system where the amount of insulin injected closely matches the blood sugar levels on a continuous basis. This can be achieved by what is known as a "closed loop system" where a small glucose sensor placed under the skin communicates with a computer containing an algorithm that drives a subcutaneous insulin pump. This system is being developed in Cambridge and is undergoing trials in children and adults with type 1 diabetes. Results thus far show that the system is very effective at preventing hypoglycaemia and maintaining blood glucose levels in target range.
We plan to test the closed loop in various challenging conditions faced by patients in daily life. One of these is the consumption of alcohol, which can give rise to delayed hypoglycaemia in patients with diabetes. The studies will be done in a clinical research facility under supervised conditions. Subjects will attend for two study nights where they will receive a specific volume of alcohol with an evening meal. On one night this will be followed by closed loop algorithm control of their insulin overnight. On the other (control) night subjects will remain on their usual pump therapy regime overnight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed loop (algorithm) | Experimental | Device: Closed loopSubcutaneous delivery of Novorapid insulin, dose calculated by computer-driven control algorithm, based on continuous glucose sensor readings |
| Open loop | Placebo comparator | Device: Conventional insulin pump deliverySubcutaneous delivery of Novorapid insulin according to usual pump regime |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 1 diabetes, as defined by WHO for at least 6 months or confirmed C-peptide negative
- On insulin pump therapy for at least 3 months
Key exclusion criteria (10 listed)
- Non-type 1 diabetes mellitus
- Any physical/psychological disease likely to interfere with the study
- Taking medication likely to interfere with interpretation of results
- Known/suspected allergy against insulin
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed loopSubcutaneous delivery of Novorapid insulin, dose calculated by control algorithm, based on continuous glucose sensor readings | Device | Closed loop (algorithm) |
| Conventional insulin pump deliverySubcutaneous delivery of Novorapid insulin according to usual pump regime | Device | Open loop |
Primary outcome
Percentage of plasma glucose values in target (3.9-8.0 mmol/L)
Time frame: 2200-1200hr
10 secondary outcomes
Percentage of CGM (continuous glucose monitoring) values in target (3.9-8.0 mmol/L)
Time frame: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
Percentage of plasma glucose and CGM values in target (3.9-8.0 mmol/L)
Time frame: 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
Percentage of plasma glucose and CGM values below 3.9 mmol/L
Time frame: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
Percentage of plasma glucose and CGM values above 8.0 mmol/L
Time frame: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
Average plasma and CGM glucose
Time frame: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
Average plasma insulin concentration
Time frame: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
Total dose of insulin administered
Time frame: 2200-1200hrs
Low blood glucose index (LBGI) score
Time frame: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
High blood glucose index (HBGI) score
Time frame: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
Percentage of plasma glucose and CGM values below 3.0 mmol/L
Time frame: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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 May 2010.
- Derived from this study: 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.
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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.
Mark L Evans, MD FRCP principal investigator
University of Cambridge, UK
Roman Hovorka, PhD study director
University of Cambridge, UK
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 and Conventional insulin pump delivery in people with Type 1 Diabetes, 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 2 inclusion and 10 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 May 2010. 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?
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?
Percentage of plasma glucose values in target (3.9-8.0 mmol/L) (time frame: 2200-1200hr). 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 NCT00944619, which also lists 1 linked publication.
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 May 2010.