Type 1 DiabetesPhase 2NCT01557634
Closing the Loop in Young Children With Type 1 Diabetes
A Phase 2 study testing Overnight closed-loop insulin delivery in people with Type 1 Diabetes, run by Daniela Elleri at 1 site in United Kingdom.
Trial summary
The incidence of type 1 diabetes (T1D) is increasing worldwide with evidence of most rapid increase in preschool children. Intensive control of blood glucose levels, although essential to protect against onset and progression of diabetes-related complications, faces unique challenges in toddlers and preschool… Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Overnight closed-loop insulin delivery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2012to Dec 2013
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The subject is between 2 and 6 years of age (inclusive)
- The subject has had type 1 diabetes, as defined by WHO criteria for at least 6 months
- The subject will be an insulin pump user and carers will have a good knowledge of insulin dose adjustment
- HbA1c below 12 % (108mmol/mol)
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
- Known or suspected allergy against insulin
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Wellcome Trust Clinical Research Facility, Addenbrooke's hospital
Cambridge, CB2 0QQ
Janet Allen, RN, +44 1223 769064, ja385@medschl.cam.ac.uk
Roman Hovorka, PhD
About this study
Official title: An Open-label, Single-centre, Randomised, 2-period Cross-over Study to Assess the Efficacy and Safety of Overnight Closed-loop Insulin Delivery Using Diluted Insulin in Comparison With Closed-loop With Non-diluted Insulin in Children With Type 1 Diabetes Aged 2 to 6 Years
The incidence of type 1 diabetes (T1D) is increasing worldwide with evidence of most rapid increase in preschool children. Intensive control of blood glucose levels, although essential to protect against onset and progression of diabetes-related complications, faces unique challenges in toddlers and preschool children. A closed-loop system can enhance accuracy of insulin delivery and help people with T1D attain a tight glucose control avoiding the risk of hypoglycaemia. The main components of the system are a continuous glucose monitor (CGM), an insulin pump and a computer-based 'model predictive algorithm', which calculates the amount of insulin to be given by the insulin pump according to the CGM values. In the studies performed thus far the efficacy and safety of closed-loop glucose control were evaluated in children and adolescents aged 6 to 18 years. The results showed that closed-loop improved control of blood glucose and prevented nocturnal hypoglycaemia, as compared to the conventional insulin pump therapy. The objective of the current study is to extend the evaluation of closed-loop further to younger children aged 2 to 6 years, who may gain a great benefit from this novel therapy. The present study adopts an open-label, randomised, 2 period cross-over design whereby closed-loop insulin therapy using diluted insulin (20IU/ml)will be compared with closed-loop with standard insulin (100IU/ml)in 12 young children with T1D. Participants aged 2 to 6 years will be randomised for two overnight studies in a clinical research facility, during which glucose levels will be controlled by either the computer-based closed-loop algorithm using diluted insulin or by closed-loop with standard insulin. On both occasions, participants will receive a self-selected evening meal and closed-loop will run from 17:00 until 08:00am the following day. The study will take place at the Wellcome Trust Clinical Research Facility, Cambridge with participants recruited from paediatric diabetes clinics in England.
- Conditions
- Type 1 Diabetes
- Being tested
- Overnight closed-loop insulin 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.
Overnight closed-loop insulin deliveryProcedure or surgery
Basal insulin infusion rates on insulin pump will be directed by MPC algorithm using diluted versus non-diluted insulin
| Study group | Role | What they receive |
|---|---|---|
| Closed-loop with diluted insulin | Experimental | Insulin pump therapy using diluted insulin (20 IU/ml) will be driven by computer-based algorithm from 1700 on Day 1 until 0800 on Day 2 Receives: Procedure: Overnight closed-loop insulin delivery |
| Closed-loop with non-diluted insulin | Active comparator | Insulin pump therapy using standard non-diluted insulin (100 IU/ml) will be driven by computer-based algorithm from 1700 on Day 1 until 0800 on Day 2 Receives: Procedure: Overnight closed-loop insulin delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in target
Time spent with plasma glucose concentration in the target range (3.9-8.0mmol/L)
Measured: Between 21:00 on Day 1 and 8:00 on Day 2
Secondary outcomes (2)
Time below target
- Time spent with plasma glucose concentration below the target range (<3.9mmol/L)
Measured: Between 21:00 on Day 1 and 8:00 on Day 2
Glucose variability
- Glucose variability as measured by standard deviation of glucose
Measured: Between 21:00 on Day 1 and 08:00 on Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daniela Elleri
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor-investigator, Daniela Elleri, University of Cambridge
- Investigators
- Roman Hovorka, PhD, Principal investigator, University of Cambrigde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557634
- Sponsor's protocol ID
- APCam10
- Status last verified
- Mar 2012
- First submitted
- 14 Mar 2012
- Last updated
- 4 Apr 2013
- 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 20138357Ruan Y, Elleri D, Allen JM, Tauschmann M, Wilinska ME, Dunger DB, Hovorka R. Pharmacokinetics of diluted (U20) insulin aspart compared with standard (U100) in children aged 3-6 years with type 1 diabetes during closed-loop insulin delivery: a randomised clinical trial. Diabetologia. 2015 Apr;58(4):687-90. doi: 10.1007/s00125-014-3483-6. Epub 2014 Dec 24.
PubMed 25537835Elleri D, Allen JM, Tauschmann M, El-Khairi R, Benitez-Aguirre P, Acerini CL, Dunger DB, Hovorka R. Feasibility of overnight closed-loop therapy in young children with type 1 diabetes aged 3-6 years: comparison between diluted and standard insulin strength. BMJ Open Diabetes Res Care. 2014 Dec 11;2(1):e000040. doi: 10.1136/bmjdrc-2014-000040. eCollection 2014.
PubMed 25512874
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-centre, Randomised, 2-period Cross-over Study to Assess the Efficacy and Safety of Overnight Closed-loop Insulin Delivery Using Diluted Insulin in Comparison With Closed-loop With Non-diluted Insulin in Children With Type 1 Diabetes Aged 2 to 6 Years
- ClinicalTrials.gov ID
- NCT01557634
- Acronym / sponsor ID
- APCam10
- Conditions
- Type 1 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Daniela ElleriUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (estimated)
- First posted
- 19 Mar 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 incidence of type 1 diabetes (T1D) is increasing worldwide with evidence of most rapid increase in preschool children. Intensive control of blood glucose levels, although essential to protect against onset and progression of diabetes-related complications, faces unique challenges in toddlers and preschool children. A closed-loop system can enhance accuracy of insulin delivery and help people with T1D attain a tight glucose control avoiding the risk of hypoglycaemia. The main components of the system are a continuous glucose monitor (CGM), an insulin pump and a computer-based 'model predictive algorithm', which calculates the amount of insulin to be given by the insulin pump according to the CGM values. In the studies performed thus far the efficacy and safety of closed-loop glucose control were evaluated in children and adolescents aged 6 to 18 years. The results showed that closed-loop improved control of blood glucose and prevented nocturnal hypoglycaemia, as compared to the conventional insulin pump therapy. The objective of the current study is to extend the evaluation of closed-loop further to younger children aged 2 to 6 years, who may gain a great benefit from this novel therapy. The present study adopts an open-label, randomised, 2 period cross-over design whereby closed-loop insulin therapy using diluted insulin (20IU/ml)will be compared with closed-loop with standard insulin (100IU/ml)in 12 young children with T1D. Participants aged 2 to 6 years will be randomised for two overnight studies in a clinical research facility, during which glucose levels will be controlled by either the computer-based closed-loop algorithm using diluted insulin or by closed-loop with standard insulin. On both occasions, participants will receive a self-selected evening meal and closed-loop will run from 17:00 until 08:00am the following day. The study will take place at the Wellcome Trust Clinical Research Facility, Cambridge with participants recruited from paediatric diabetes clinics in England.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed-loop with diluted insulin | Experimental | Procedure: Overnight closed-loop insulin deliveryInsulin pump therapy using diluted insulin (20 IU/ml) will be driven by computer-based algorithm from 1700 on Day 1 until 0800 on Day 2 |
| Closed-loop with non-diluted insulin | Active comparator | Procedure: Overnight closed-loop insulin deliveryInsulin pump therapy using standard non-diluted insulin (100 IU/ml) will be driven by computer-based algorithm from 1700 on Day 1 until 0800 on Day 2 |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The subject is between 2 and 6 years of age (inclusive)
- The subject has had type 1 diabetes, as defined by WHO criteria for at least 6 months
- The subject will be an insulin pump user and carers will have a good knowledge of insulin dose adjustment
- HbA1c below 12 % (108mmol/mol)
Key exclusion criteria (4 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
- Known or suspected allergy against insulin
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 |
|---|---|---|
| Overnight closed-loop insulin deliveryBasal insulin infusion rates on insulin pump will be directed by MPC algorithm using diluted versus non-diluted insulin | Procedure or surgery | Closed-loop with diluted insulin, Closed-loop with non-diluted insulin |
Primary outcome
Time in target
Time frame: Between 21:00 on Day 1 and 8:00 on Day 2
Time spent with plasma glucose concentration in the target range (3.9-8.0mmol/L)
2 secondary outcomes
Time below target
Time frame: Between 21:00 on Day 1 and 8:00 on Day 2
Glucose variability
Time frame: Between 21:00 on Day 1 and 08:00 on Day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
- 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.
- Derived from this study: PubMed 25537835Ruan Y, Elleri D, Allen JM, Tauschmann M, Wilinska ME, Dunger DB, Hovorka R. Pharmacokinetics of diluted (U20) insulin aspart compared with standard (U100) in children aged 3-6 years with type 1 diabetes during closed-loop insulin delivery: a randomised clinical trial. Diabetologia. 2015 Apr;58(4):687-90. doi: 10.1007/s00125-014-3483-6. Epub 2014 Dec 24.
- Derived from this study: PubMed 25512874Elleri D, Allen JM, Tauschmann M, El-Khairi R, Benitez-Aguirre P, Acerini CL, Dunger DB, Hovorka R. Feasibility of overnight closed-loop therapy in young children with type 1 diabetes aged 3-6 years: comparison between diluted and standard insulin strength. BMJ Open Diabetes Res Care. 2014 Dec 11;2(1):e000040. doi: 10.1136/bmjdrc-2014-000040. eCollection 2014.
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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 Cambrigde
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 Overnight closed-loop insulin delivery in people with Type 1 Diabetes, run by Daniela Elleri 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 4 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: status not confirmed, as of the sponsor's last update on 4 Apr 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniela Elleri, MD (+44 1223 7969069, de250@medschl.cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in target (time frame: Between 21:00 on Day 1 and 8:00 on Day 2). 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 NCT01557634, which also lists 3 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 4 Apr 2013.