Type 1 DiabetesPhase 2NCT01074801
Closing the Loop for 36 Hours in Adolescents With Type 1 Diabetes
A Phase 2 study testing Closed-loop insulin delivery and Standard insulin pump treatment in people with Type 1 Diabetes, run by University of Cambridge at 1 site in United Kingdom.
Trial summary
High variability of blood sugar levels and high incidence of night-time hypoglycaemia (low blood sugar) in young people with type 1 diabetes (T1D) make achieving the treatment goals in this population extremely challenging. 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 and Standard insulin pump treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2010to Oct 2010
- 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 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
- Postmenarchal girls who are pregnant or intending to become pregnant or are breastfeeding
- Any coexisting cardiac and respiratory condition (including asthma)
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, Randomised, 2-period Cross-over Study to Assess the Efficacy and Safety of 36-hour Closed-loop Glucose Control in Comparison With Conventional Subcutaneous Insulin Pump Treatment in Adolescents With Type 1 Diabetes
High variability of blood sugar levels and high incidence of night-time hypoglycaemia (low blood sugar) in young people with type 1 diabetes (T1D) make achieving the treatment goals in this population extremely challenging.
Our ongoing research focuses on the development of a closed-loop glucose control in children and adolescents with T1D. The three components of the closed-loop system are a continuous glucose monitor, an insulin pump, and a computer-based algorithm. The studies performed thus far evaluated the efficacy and safety of overnight closed-loop glucose control. The results showed that overnight closed-loop improved control of blood glucose and prevented nocturnal hypoglycaemia, as compared to the conventional insulin pump therapy. The next objective is to evaluate the efficacy and safety of closed-loop insulin delivery over a prolonged time period, including the daytime, when normal living activities occur. This will pave the way for a more comprehensive use of closed loop systems to control glucose levels in T1D.
The present study adopts an open-label, randomised, 2-period cross-over design whereby the safety and efficacy of closed-loop insulin therapy will be compared with the conventional insulin pump therapy in 12 adolescents with T1D. Participants aged 12 to 18 years will be randomised for two 36 hour studies in a clinical research facility, during which glucose levels will be controlled by either the computer-based closed-loop algorithm (intervention arm) or by conventional insulin pump therapy (control arm). During both studies participants will perform normal daily activities, i.e. playing, reading, snacking and physical activity. On both occasions, the Actiheart, a combined heart rate and movement sensor will be used to accurately quantify each subject's individual physical activity energy expenditure during the 36 hour study period and for 36 hours of free living during weekday.
Read the detailed description
The study is an open-label, randomised, 2-period crossover study comparing the closed-loop insulin therapy with the conventional insulin pump therapy in 12 adolescents with type 1 diabetes.
Subjects who consented to take part in the study will attend the Clinical Research Facility on two occasions, each lasting 36 hours. Approximately 1-3 days prior to each Study Visit, a subcutaneous continuous glucose monitoring (CGM) device will be inserted.
On each Study Visit subjects will arrive between 17:30 and 18:00 and will stay in the clinical research facility for two nights.
Shortly after arrival the subjects will have Actiheart monitor fitted and a cannula inserted into a vein of one arm for blood sampling purposes. Blood sampling for plasma glucose and plasma insulin will start at 18:30 and will be carried out at 30 minutes intervals during the day and at 60min intervals during the night throughout the study period. Plasma glucose measurements will be done in real time every 30min during the day and every 60min during the night except when when plasma glucose < 3.5mmol/L or following treatment for hypoglycaemia, when the measurements will be carried out every 15 minutes.
On Study Visit 1 the subjects will be randomised on arrival to receive either the conventional insulin pump therapy or the closed-loop intervention. At 18:30 subjects will perform 5 to 10 minutes exercise on a bicycle to determine the settings needed to achieve a heart rate of 140 bpm corresponding to an exercise level at 55%60% of peak VO2. In the closed-loop intervention arm the insulin pump therapy will be driven by the computer-based algorithm from 19:30 until the end of the study. The basal insulin infusion rate on the insulin pump will be adjusted manually at 15min intervals following the computer-based algorithm advice. During the control arm, the subject will carry on with their usual insulin pump regimen. In both groups CGM will be continued throughout the whole of the study period. Subjects who completed Study Visit 1 will cross over to the alternative Study Visit schedule after an interval of 1 to 6 weeks.
- Conditions
- Type 1 Diabetes
- Being tested
- Closed-loop insulin delivery, Standard insulin pump treatment
- Keywords
- Closed-loop systems, day-and-night glucose control
- 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-loop insulin deliveryOther
Basal subcutaneous insulin delivery to be adjusted at 15min cycles according to the computer-based algorithm advice.
Standard insulin pump treatmentOther
Subcutaneous insulin delivery to be performed based on subjects' standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Closed-loop | Active comparator | Subcutaneous insulin delivery to be adjusted according to the computer-based algorithm advice, based on subcutaneous glucose readings Receives: Other: Closed-loop insulin delivery |
| Control arm | Active comparator | Subcutaneous insulin delivery to be administered according the standard insulin pump settings Receives: Other: Standard insulin pump treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is time spent with plasma glucose concentration in the target range (3.9-10.0 mmol/L) between 24:00 on Day 1 to 08:00 on Day 3.
Measured: 32 hours
Secondary outcomes (1)
Secondary outcomes will include: (i) Total and basal insulin delivery between 24:00 on Day 1 and 08:00 on Day 3 (36 hours) (ii) CGM glucose levels between 24:00 on Day 1 and 08:00 on Day 3 (36 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 posted24 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Roman Hovorka, PhD, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074801
- Sponsor's protocol ID
- DAN01
- Status last verified
- Feb 2010
- First submitted
- 23 Feb 2010
- Last updated
- 6 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomised, 2-period Cross-over Study to Assess the Efficacy and Safety of 36-hour Closed-loop Glucose Control in Comparison With Conventional Subcutaneous Insulin Pump Treatment in Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01074801
- Acronym / sponsor ID
- DAN01
- Conditions
- Type 1 Diabetes
- Keywords
- Closed-loop systems, day-and-night glucose control
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Study start
- Mar 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 24 Feb 2010 (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.
High variability of blood sugar levels and high incidence of night-time hypoglycaemia (low blood sugar) in young people with type 1 diabetes (T1D) make achieving the treatment goals in this population extremely challenging.
Our ongoing research focuses on the development of a closed-loop glucose control in children and adolescents with T1D. The three components of the closed-loop system are a continuous glucose monitor, an insulin pump, and a computer-based algorithm. The studies performed thus far evaluated the efficacy and safety of overnight closed-loop glucose control. The results showed that overnight closed-loop improved control of blood glucose and prevented nocturnal hypoglycaemia, as compared to the conventional insulin pump therapy. The next objective is to evaluate the efficacy and safety of closed-loop insulin delivery over a prolonged time period, including the daytime, when normal living activities occur. This will pave the way for a more comprehensive use of closed loop systems to control glucose levels in T1D.
The present study adopts an open-label, randomised, 2-period cross-over design whereby the safety and efficacy of closed-loop insulin therapy will be compared with the conventional insulin pump therapy in 12 adolescents with T1D. Participants aged 12 to 18 years will be randomised for two 36 hour studies in a clinical research facility, during which glucose levels will be controlled by either the computer-based closed-loop algorithm (intervention arm) or by conventional insulin pump therapy (control arm). During both studies participants will perform normal daily activities, i.e. playing, reading, snacking and physical activity. On both occasions, the Actiheart, a combined heart rate and movement sensor will be used to accurately quantify each subject's individual physical activity energy expenditure during the 36 hour study period and for 36 hours of free living during weekday.
Detailed description
The study is an open-label, randomised, 2-period crossover study comparing the closed-loop insulin therapy with the conventional insulin pump therapy in 12 adolescents with type 1 diabetes.
Subjects who consented to take part in the study will attend the Clinical Research Facility on two occasions, each lasting 36 hours. Approximately 1-3 days prior to each Study Visit, a subcutaneous continuous glucose monitoring (CGM) device will be inserted.
On each Study Visit subjects will arrive between 17:30 and 18:00 and will stay in the clinical research facility for two nights.
Shortly after arrival the subjects will have Actiheart monitor fitted and a cannula inserted into a vein of one arm for blood sampling purposes. Blood sampling for plasma glucose and plasma insulin will start at 18:30 and will be carried out at 30 minutes intervals during the day and at 60min intervals during the night throughout the study period. Plasma glucose measurements will be done in real time every 30min during the day and every 60min during the night except when when plasma glucose < 3.5mmol/L or following treatment for hypoglycaemia, when the measurements will be carried out every 15 minutes.
On Study Visit 1 the subjects will be randomised on arrival to receive either the conventional insulin pump therapy or the closed-loop intervention. At 18:30 subjects will perform 5 to 10 minutes exercise on a bicycle to determine the settings needed to achieve a heart rate of 140 bpm corresponding to an exercise level at 55%60% of peak VO2. In the closed-loop intervention arm the insulin pump therapy will be driven by the computer-based algorithm from 19:30 until the end of the study. The basal insulin infusion rate on the insulin pump will be adjusted manually at 15min intervals following the computer-based algorithm advice. During the control arm, the subject will carry on with their usual insulin pump regimen. In both groups CGM will be continued throughout the whole of the study period. Subjects who completed Study Visit 1 will cross over to the alternative Study Visit schedule after an interval of 1 to 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed-loop | Active comparator | Other: Closed-loop insulin deliverySubcutaneous insulin delivery to be adjusted according to the computer-based algorithm advice, based on subcutaneous glucose readings |
| Control arm | Active comparator | Other: Standard insulin pump treatmentSubcutaneous insulin delivery to be administered according the standard insulin pump settings |
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 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 deliveryBasal subcutaneous insulin delivery to be adjusted at 15min cycles according to the computer-based algorithm advice. | Other | Closed-loop |
| Standard insulin pump treatmentSubcutaneous insulin delivery to be performed based on subjects' standard treatment | Other | Control arm |
Primary outcome
The primary outcome measure is time spent with plasma glucose concentration in the target range (3.9-10.0 mmol/L) between 24:00 on Day 1 to 08:00 on Day 3.
Time frame: 32 hours
1 secondary outcome
Secondary outcomes will include: (i) Total and basal insulin delivery between 24:00 on Day 1 and 08:00 on Day 3 (36 hours) (ii) CGM glucose levels between 24:00 on Day 1 and 08:00 on Day 3 (36 hours)
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 6 Apr 2011.
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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 and Standard insulin pump treatment 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 6 Apr 2011. 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?
The primary outcome measure is time spent with plasma glucose concentration in the target range (3.9-10.0 mmol/L) between 24:00 on Day 1 to 08:00 on Day 3. (time frame: 32 hours). 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 6 Apr 2011.