Type 1 DiabetesPhase 2NCT01629251
Closing the Loop for 36 Hours in Adolescents With Type 1 Diabetes: Evaluation of Reduced Meal Bolusing
A Phase 2 study testing Closed-loop insulin delivery in people with Type 1 Diabetes, run by University of Cambridge at 1 site in United Kingdom.
Trial summary
The main focus of our research is the development of a closed-loop system for glucose control in people with type 1 diabetes. After having demonstrated the safety and efficacy of overnight closed-loop insulin delivery, we are extending the evaluation of closed-loop to the daytime. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Closed-loop insulin delivery
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2011to Sep 2011
- Phase
- Phase 2
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The subject is between 12 and 18 years of age (inclusive).
- The subject has had type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative.
- The subject will have been on insulin pump user for at least 3 months, with good knowledge of insulin self-adjustment.
- HbA1c ≤ 12 % based on analysis from central laboratory
Who cannot join
- Non-type 1 diabetes mellitus including those secondary to chronic disease
- Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results
- Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers and MAO inhibitors
- Known or suspected allergy against insulin
- Subjects with clinical significant nephropathy, neuropathy or proliferative retinopathy as judged by the clinician
- Total daily insulin dose >= 2 IU/kg
- Post-menarchal girls who are pregnant or intending to become pregnant or are breastfeeding
- Any coexisting cardiac and respiratory condition
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
The main focus of our research is the development of a closed-loop system for glucose control in people with type 1 diabetes. After having demonstrated the safety and efficacy of overnight closed-loop insulin delivery, we are extending the evaluation of closed-loop to the daytime. Meal-related insulin dosing can be challenging and prandial insulin overdosing can be associated with the occurrence of postprandial hypoglycaemia, thus representing a confounding factor of hypoglycaemia free glucose control during the day. A further investigation is needed to evaluate alternative strategies for prandial insulin dosing. We will study eight adolescents with type 1 diabetes during closed-loop insulin delivery combined with either standard or reduced insulin doses with the meals, in a randomised crossover design. Stable glucose isotopes will be administered to collect data for modelling of glucose turnover around the meals, during daily activities and overnight.
The information provided by the use of glucose isotopes would be very helpful to increase our understanding of the physiology of glucose turnover and to facilitate the development of an improved control algorithm. Ultimately this study will help with the development of a closed-loop system to match insulin infusions to change in glucose levels in real life conditions.
- Conditions
- Type 1 Diabetes
- Being tested
- Closed-loop insulin delivery
- Keywords
- Closed-loop insulin delivery, Post-prandial hypoglycaemia, Meal insulin dosing
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-loop insulin deliveryDevice
Subcutaneous basal insulin delivery will be adjusted following the advice by a computer-based algorithm, based on subcutaneous sensor glucose readings. Standard or reduced meal insulin dosing will be performed in a randomised design.
| Study group | Role | What they receive |
|---|---|---|
| Closed-loop with standard meal insulin bolus | Active comparator | Subcutaneous basal insulin delivery will be adjusted following the advice by a computer-based algorithm, based on subcutaneous sensor glucose readings. Standard meal insulin dosing will be performed at each meal, following individual standard clinical practice. Receives: Device: Closed-loop insulin delivery |
| Closed-loop with reduced meal insulin bolus | Experimental | Subcutaneous basal insulin delivery will be adjusted following the advice by a computer-based algorithm, based on subcutaneous sensor glucose readings. The standard meal insulin dose will be reduced by 20 to 50%. Receives: Device: Closed-loop insulin delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoint
The primary outcome measure is time spent with plasma glucose concentration in the target range (3.9-10.0mmol/L) between 24:00 on Day 1 and 08:00 on Day 3 (32 hours) as obtained with closed-loop insulin delivery in comparison with conventional insulin pump therapy.
Measured: 36hours
Secondary outcomes (1)
Secondary efficacy endpoints
- Total and basal insulin delivery between 24:00 on Day 1 and 08:00 on Day 3 (36 hours)
- CGM glucose levels between 24:00 on Day 1 and 08:00 on Day 3 (36 hours)
- Overnight glucose levels between 24:00 on Day 1 and 08:00 on Day 2 (8 hours), and between 24:00 on Day 2 and 08:00 on Day 3 (8 hours)
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startApr 2011
- Primary completionSep 2011
- Study completionSep 2011
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 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, Dr Roman Hovorka, University of Cambridge
- Investigators
- Roman Hovorka, PhD, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629251
- Sponsor's protocol ID
- DAN02
- Status last verified
- Jun 2012
- First submitted
- 5 Apr 2011
- Last updated
- 27 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Hovorka R, Allen JM, Elleri D, Chassin LJ, Harris J, Xing D, Kollman C, Hovorka T, Larsen AM, Nodale M, De Palma A, Wilinska ME, Acerini CL, Dunger DB. Manual closed-loop insulin delivery in children and adolescents with type 1 diabetes: a phase 2 randomised crossover trial. Lancet. 2010 Feb 27;375(9716):743-51. doi: 10.1016/S0140-6736(09)61998-X. Epub 2010 Feb 4.
PubMed 20138357
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closing the Loop for 36 Hours in Adolescents With Type 1 Diabetes: Evaluation of Reduced Meal Bolusing
- ClinicalTrials.gov ID
- NCT01629251
- Acronym / sponsor ID
- DAN02
- Conditions
- Type 1 Diabetes
- Keywords
- Closed-loop insulin delivery, Post-prandial hypoglycaemia, Meal insulin dosing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Study start
- Apr 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 27 Jun 2012 (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 focus of our research is the development of a closed-loop system for glucose control in people with type 1 diabetes. After having demonstrated the safety and efficacy of overnight closed-loop insulin delivery, we are extending the evaluation of closed-loop to the daytime. Meal-related insulin dosing can be challenging and prandial insulin overdosing can be associated with the occurrence of postprandial hypoglycaemia, thus representing a confounding factor of hypoglycaemia free glucose control during the day. A further investigation is needed to evaluate alternative strategies for prandial insulin dosing. We will study eight adolescents with type 1 diabetes during closed-loop insulin delivery combined with either standard or reduced insulin doses with the meals, in a randomised crossover design. Stable glucose isotopes will be administered to collect data for modelling of glucose turnover around the meals, during daily activities and overnight.
The information provided by the use of glucose isotopes would be very helpful to increase our understanding of the physiology of glucose turnover and to facilitate the development of an improved control algorithm. Ultimately this study will help with the development of a closed-loop system to match insulin infusions to change in glucose levels in real life conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed-loop with standard meal insulin bolus | Active comparator | Device: Closed-loop insulin deliverySubcutaneous basal insulin delivery will be adjusted following the advice by a computer-based algorithm, based on subcutaneous sensor glucose readings. Standard meal insulin dosing will be performed at each meal, following individual standard clinical practice. |
| Closed-loop with reduced meal insulin bolus | Experimental | Device: Closed-loop insulin deliverySubcutaneous basal insulin delivery will be adjusted following the advice by a computer-based algorithm, based on subcutaneous sensor glucose readings. The standard meal insulin dose will be reduced by 20 to 50%. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- The subject is between 12 and 18 years of age (inclusive).
- The subject has had type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative.
- The subject will have been on insulin pump user for at least 3 months, with good knowledge of insulin self-adjustment.
- HbA1c ≤ 12 % based on analysis from central laboratory
Key exclusion criteria (8 listed)
- Non-type 1 diabetes mellitus including those secondary to chronic disease
- Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results
- Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers and MAO inhibitors
- Known or suspected allergy against insulin
- Subjects with clinical significant nephropathy, neuropathy or proliferative retinopathy as judged by the clinician
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 deliverySubcutaneous basal insulin delivery will be adjusted following the advice by a computer-based algorithm, based on subcutaneous sensor glucose readings. Standard or reduced meal insulin dosing will be performed in a randomised design. | Device | Closed-loop with reduced meal insulin bolus, Closed-loop with standard meal insulin bolus |
Primary outcome
Primary efficacy endpoint
Time frame: 36hours
The primary outcome measure is time spent with plasma glucose concentration in the target range (3.9-10.0mmol/L) between 24:00 on Day 1 and 08:00 on Day 3 (32 hours) as obtained with closed-loop insulin delivery in comparison with conventional insulin pump therapy.
1 secondary outcome
Secondary efficacy endpoints
Time frame: 36 hours
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 27 Jun 2012.
- Background: PubMed 20138357Hovorka R, Allen JM, Elleri D, Chassin LJ, Harris J, Xing D, Kollman C, Hovorka T, Larsen AM, Nodale M, De Palma A, Wilinska ME, Acerini CL, Dunger DB. Manual closed-loop insulin delivery in children and adolescents with type 1 diabetes: a phase 2 randomised crossover trial. Lancet. 2010 Feb 27;375(9716):743-51. doi: 10.1016/S0140-6736(09)61998-X. Epub 2010 Feb 4.
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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 Phase 2 study testing Closed-loop insulin 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 4 inclusion and 8 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 27 Jun 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Primary efficacy endpoint (time frame: 36hours). 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 NCT01629251, 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 27 Jun 2012; AzTrials last refreshed its copy on 1 Nov 2026.