Type 1 DiabetesANGELA01NCT00910767
Closing the Loop in Adults With Type 1 Diabetes
A study testing Conventional insulin pump delivery and Closed loop in people with Type 1 Diabetes, run by University of Cambridge at 1 site in United Kingdom.
Trial summary
The main objective of this study is to evaluate the feasibility of closed loop insulin pump therapy to improve overnight glucose control in adults with type 1 diabetes. 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?
- Conventional insulin pump delivery and Closed loop
- 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
- Feb 2009to Jul 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 the results
- Known/suspected allergy against insulin
- Patients with clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator
- Ongoing severe recurrent hypoglycaemia as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, 2-period Cross-over Study to Assess the Feasibility of Overnight Computer-based Glucose Control Based on Continuous Subcutaneous Glucose Monitoring, and Compare it With Conventional Pump Therapy in Adults With Type 1 Diabetes
The main objective of this study is to evaluate the feasibility of closed loop insulin pump therapy to improve overnight glucose control in adults with type 1 diabetes.
Read the detailed description
People with type 1 diabetes(T1D) need regular insulin injections or continuous delivery of insulin using an insulin pump in order to keep the blood glucose levels normal. We know that keeping blood sugars in the normal range will help prevent long term diabetes related 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). This is a particular problem at night and one solution is to develop a system whereby the amount of insulin injected is very closely matched to the blood sugar levels on a continuous basis. This can be achieved by what is called a "closed loop system" where a small glucose sensor placed under the skin communicates with a computer containing an algorithm that drives an insulin pump. This system is being developed in Cambridge and we have trialed this on 16 children and adolescents with T1D in a clinical setting over the past year. We have found that this system is very effective at preventing hypoglycaemia in this group of patients.
We will recruit 12 adults with T1D on insulin pump therapy, and the studies will be done in a clinical research facility. The subjects will be studied on two nights. On one night they will have their normal insulin pump therapy and on the other night their insulin pump will be varied according to information about blood glucose values from the continuous glucose sensor. This information will be manually typed into the computer every 15 minutes from 8pm until 8am. The algorithm will advise of the insulin infusion rate and this will be manually changed by a trained nurse every 15 minutes throughout the night.
- Conditions
- Type 1 Diabetes
- Being tested
- Conventional insulin pump delivery, Closed loop
- 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.
Conventional insulin pump deliveryDevice
Subcutaneous delivery of Novorapid insulin according to usual pump regime
Closed loopDevice
Subcutaneous delivery of Novorapid insulin, dose calculated by control algorithm, based on continuous glucose sensor readings
| Study group | Role | What they receive |
|---|---|---|
| Closed loop (algorithm) | Experimental | Not described Receives: Device: Closed loop |
| Open loop | Placebo comparator | Not described 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: 1900 to 0800hr
Secondary outcomes (25)
Percentage of CGM (continuous glucose monitoring) values in target (3.9-8.0 mmol/L)
Measured: 1900 to 0800hr
Percentage of plasma glucose and CGM values in target (3.9-8.0 mmol/L)
Measured: 0000 to 0800hr
Percentage of plasma glucose and CGM values in target (3.9-8.0 mmol/L)
Measured: 0800 to 1200hr
Percentage of plasma glucose and CGM values below 3.9 mmol/L
Measured: 1900 to 0800hr
Percentage of plasma glucose and CGM values below 3.9 mmol/L
Measured: 0000 to 0800hr
Percentage of plasma glucose and CGM values below 3.9 mmol/L
Measured: 0800 to 1200hr
Percentage of plasma glucose and CGM values above 8.0 mmol/L
Measured: 1900 to 0800hr
Percentage of plasma glucose and CGM values above 8.0 mmol/L
Measured: 0000 to 0800hr
Percentage of plasma glucose and CGM values above 8.0 mmol/L
Measured: 0800 to 1200hr
Average plasma and CGM glucose
Measured: 1900 to 0800hr
Average plasma and CGM glucose
Measured: 0000 to 0800hr
Average plasma and CGM glucose
Measured: 0800 to 1200hr
Average plasma insulin concentration
Measured: 1900 to 0800hr
Average plasma insulin concentration
Measured: 0000 to 0800hr
Average plasma insulin concentration
Measured: 0800 to 1200hr
Total dose of insulin administered
Measured: 1900 to 0800hr
low blood glucose index (LBGI) score
Measured: 1900 to 0800hr
high blood glucose index (HBGI) score
Measured: 1900 to 0800hr
low blood glucose index (LBGI) score
Measured: 0000 to 0800hr
low blood glucose index (LBGI) score
Measured: 0800 to 1200hr
high blood glucose index (HBGI) score
Measured: 0000 to 0800hr
high blood glucose index (HBGI) score
Measured: 0800 to 1200hr
Percentage of plasma glucose and CGM values below 3.0 mmol/L
Measured: 1900 to 0800hr
Percentage of plasma glucose and CGM values below 3.0 mmol/L
Measured: 0000 to 0800hr
Percentage of plasma glucose and CGM values below 3.0 mmol/L
Measured: 0800 to 1200hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2009
- Study completionJul 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, Diabetes UK
- 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
- NCT00910767
- Sponsor's protocol ID
- 08/H0308/297
- Acronym
- ANGELA01
- Status last verified
- Sep 2009
- First submitted
- 28 May 2009
- Last updated
- 17 Sep 2009
- 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 17 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, 2-period Cross-over Study to Assess the Feasibility of Overnight Computer-based Glucose Control Based on Continuous Subcutaneous Glucose Monitoring, and Compare it With Conventional Pump Therapy in Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00910767
- Acronym / sponsor ID
- ANGELA01 / 08/H0308/297
- 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, Diabetes UK
- Study start
- Feb 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 1 Jun 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 of this study is to evaluate the feasibility of closed loop insulin pump therapy to improve overnight glucose control in adults with type 1 diabetes.
Detailed description
People with type 1 diabetes(T1D) need regular insulin injections or continuous delivery of insulin using an insulin pump in order to keep the blood glucose levels normal. We know that keeping blood sugars in the normal range will help prevent long term diabetes related 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). This is a particular problem at night and one solution is to develop a system whereby the amount of insulin injected is very closely matched to the blood sugar levels on a continuous basis. This can be achieved by what is called a "closed loop system" where a small glucose sensor placed under the skin communicates with a computer containing an algorithm that drives an insulin pump. This system is being developed in Cambridge and we have trialed this on 16 children and adolescents with T1D in a clinical setting over the past year. We have found that this system is very effective at preventing hypoglycaemia in this group of patients.
We will recruit 12 adults with T1D on insulin pump therapy, and the studies will be done in a clinical research facility. The subjects will be studied on two nights. On one night they will have their normal insulin pump therapy and on the other night their insulin pump will be varied according to information about blood glucose values from the continuous glucose sensor. This information will be manually typed into the computer every 15 minutes from 8pm until 8am. The algorithm will advise of the insulin infusion rate and this will be manually changed by a trained nurse every 15 minutes throughout the night.
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 loop |
| Open loop | Placebo comparator | Device: Conventional insulin pump delivery |
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 (6 listed)
- Non-type 1 diabetes mellitus
- Any physical/psychological disease likely to interfere with the study
- Taking medication likely to interfere with interpretation of the results
- Known/suspected allergy against insulin
- Patients with 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 |
|---|---|---|
| Conventional insulin pump deliverySubcutaneous delivery of Novorapid insulin according to usual pump regime | Device | Open loop |
| Closed loopSubcutaneous delivery of Novorapid insulin, dose calculated by control algorithm, based on continuous glucose sensor readings | Device | Closed loop (algorithm) |
Primary outcome
Percentage of plasma glucose values in target (3.9 - 8.0 mmol/L)
Time frame: 1900 to 0800hr
25 secondary outcomes
Percentage of CGM (continuous glucose monitoring) values in target (3.9-8.0 mmol/L)
Time frame: 1900 to 0800hr
Percentage of plasma glucose and CGM values in target (3.9-8.0 mmol/L)
Time frame: 0000 to 0800hr
Percentage of plasma glucose and CGM values in target (3.9-8.0 mmol/L)
Time frame: 0800 to 1200hr
Percentage of plasma glucose and CGM values below 3.9 mmol/L
Time frame: 1900 to 0800hr
Percentage of plasma glucose and CGM values below 3.9 mmol/L
Time frame: 0000 to 0800hr
Percentage of plasma glucose and CGM values below 3.9 mmol/L
Time frame: 0800 to 1200hr
Percentage of plasma glucose and CGM values above 8.0 mmol/L
Time frame: 1900 to 0800hr
Percentage of plasma glucose and CGM values above 8.0 mmol/L
Time frame: 0000 to 0800hr
Percentage of plasma glucose and CGM values above 8.0 mmol/L
Time frame: 0800 to 1200hr
Average plasma and CGM glucose
Time frame: 1900 to 0800hr
Average plasma and CGM glucose
Time frame: 0000 to 0800hr
Average plasma and CGM glucose
Time frame: 0800 to 1200hr
Average plasma insulin concentration
Time frame: 1900 to 0800hr
Average plasma insulin concentration
Time frame: 0000 to 0800hr
Average plasma insulin concentration
Time frame: 0800 to 1200hr
Total dose of insulin administered
Time frame: 1900 to 0800hr
low blood glucose index (LBGI) score
Time frame: 1900 to 0800hr
high blood glucose index (HBGI) score
Time frame: 1900 to 0800hr
low blood glucose index (LBGI) score
Time frame: 0000 to 0800hr
low blood glucose index (LBGI) score
Time frame: 0800 to 1200hr
high blood glucose index (HBGI) score
Time frame: 0000 to 0800hr
high blood glucose index (HBGI) score
Time frame: 0800 to 1200hr
Percentage of plasma glucose and CGM values below 3.0 mmol/L
Time frame: 1900 to 0800hr
Percentage of plasma glucose and CGM values below 3.0 mmol/L
Time frame: 0000 to 0800hr
Percentage of plasma glucose and CGM values below 3.0 mmol/L
Time frame: 0800 to 1200hr
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 17 Sep 2009.
- 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.
Related trials for Type 1 Diabetes
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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 Conventional insulin pump delivery and Closed loop 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 6 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 17 Sep 2009. 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: 1900 to 0800hr). 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 NCT00910767, 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 17 Sep 2009.