Type 1 Diabetes MellitusNCT01421225
Closed-Loop Insulin Delivery in Children Less Than 7 Years of Age
A study testing Closed-loop Insulin Pump therapy and Standard Insulin Pump Therapy in people with Type 1 Diabetes Mellitus, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The investigators are conducting this study to find out whether a new device can control blood sugar levels in children who have Type 1 diabetes. In Type 1 diabetes, children have high blood sugar levels because they do not make enough insulin. Read more about this study
- Who is it for?
- Ages 6 months to 7 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Closed-loop Insulin Pump therapy and Standard Insulin Pump Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to 15 Aug 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 months to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age < 7 years old
- Type 1 Diabetes (as diagnosed by outpatient endocrinologist) with duration greater than 6 months
- Treated with insulin pump therapy for greater than 6 weeks
Who cannot join
- Any other chronic medical condition
- Weight below 10 kg as this is the minimal required weight for the amount of blood being drawn
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
The investigators are conducting this study to find out whether a new device can control blood sugar levels in children who have Type 1 diabetes. In Type 1 diabetes, children have high blood sugar levels because they do not make enough insulin. The standard treatment is to give insulin either by shots or using an insulin pump. A new device, called closed-loop insulin therapy, uses a continuous glucose monitor (CGMs) linked to an insulin pump by a computer. The CGM will send the sugar levels to a computer which automatically figures out how much insulin to give and then gives that amount of insulin through the insulin pump. It will give the child insulin to bring sugar levels down if they are high, and will give less insulin if the child's blood sugar is getting lower. Earlier research using closed-loop insulin therapy has shown the ability for it to improve diabetes care in adults and older children, but there has been no research of closed-loop insulin therapy in young children. This study will compare children's current insulin therapy with the closed-loop system. The knowledge that the investigators gain from this research will help us to figure out whether closed-loop therapy can work in young children, hopefully leading to better Type 1 diabetes care.
Read the detailed description
We will perform a randomized cross-over study of semi-closed-loop insulin therapy in children less than 7 years old with type 1 diabetes. Subjects will be admitted to the inpatient clinical research center for 48 hours. They will receive their standard home insulin therapy for one day and semi-closed-loop insulin therapy for the other day.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Closed-loop Insulin Pump therapy, Standard Insulin Pump Therapy
- Keywords
- Closed Loop Insulin Delivery, Diabetes, Type 1 Diabetes, Artificial pancreas
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-loop Insulin Pump therapyDevice
Also called Continuous glucose monitor and computer-linked insulin pump
Subjects insulin doses were adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon.
Standard Insulin Pump TherapyDevice
Also called Open-Loop Therapy
Subjects insulin doses followed their usual home routine.
| Study group | Role | What they receive |
|---|---|---|
| Standard Insulin Pump Therapy first, then Closed Loop | Active comparator | Standard therapy day 1, Closed-Loop therapy day 2. Receives: Device: Closed-loop Insulin Pump therapy; Device: Standard Insulin Pump Therapy |
| Closed Loop first, then Standard Insulin Pump Therapy | Active comparator | Closed-loop therapy day 1, standard therapy day 2. Receives: Device: Closed-loop Insulin Pump therapy; Device: Standard Insulin Pump Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nocturnal Glycemic Control
Time spent within target glucose range based on the glucose meter measurements between 10 PM and 8 AM. The target range is 110-200 mg/dl as this is the American Diabetes Association defined target overnight range for this age group.
Measured: Participants will be followed for the duration of the 48 hour protocol.
Secondary outcomes (3)
Post-prandial Glycemic Control
Peak post-prandial blood sugar between 8 AM and noon
Measured: Participants will be followed for the duration of the 48 hour protocol
Number of Interventions for Hypoglycemia
The number of interventions for hypoglycemia between 10 PM - 8 AM.
Measured: Participants will be followed for the duration of the 48 hour protocol
Pre-lunch Blood Glucose Level
Blood glucose levels were documented at 12 pm just prior to being served lunch.
Measured: Participants will be followed for the duration of the 48 hour protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startAug 2011
- Primary completion15 Aug 2013
- Study completion15 Aug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Garry Steil, Boston Children's Hospital
- Investigators
- Andrew Dauber, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421225
- Sponsor's protocol ID
- IRB-P00000231
- Status last verified
- Aug 2018
- First submitted
- 19 Aug 2011
- Last updated
- 9 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Dauber A, Corcia L, Safer J, Agus MS, Einis S, Steil GM. Closed-loop insulin therapy improves glycemic control in children aged <7 years: a randomized controlled trial. Diabetes Care. 2013 Feb;36(2):222-7. doi: 10.2337/dc12-1079. Epub 2012 Oct 1.
PubMed 23033237
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed-Loop Insulin Delivery in Children Less Than 7 Years of Age
- ClinicalTrials.gov ID
- NCT01421225
- Acronym / sponsor ID
- IRB-P00000231
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Closed Loop Insulin Delivery, Diabetes, Type 1 Diabetes, Artificial pancreas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- 15 Aug 2013 (actual)
- Study completion
- 15 Aug 2013 (actual)
- First posted
- 22 Aug 2011 (estimated)
- Results
- Posted 7 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are conducting this study to find out whether a new device can control blood sugar levels in children who have Type 1 diabetes. In Type 1 diabetes, children have high blood sugar levels because they do not make enough insulin. The standard treatment is to give insulin either by shots or using an insulin pump. A new device, called closed-loop insulin therapy, uses a continuous glucose monitor (CGMs) linked to an insulin pump by a computer. The CGM will send the sugar levels to a computer which automatically figures out how much insulin to give and then gives that amount of insulin through the insulin pump. It will give the child insulin to bring sugar levels down if they are high, and will give less insulin if the child's blood sugar is getting lower. Earlier research using closed-loop insulin therapy has shown the ability for it to improve diabetes care in adults and older children, but there has been no research of closed-loop insulin therapy in young children. This study will compare children's current insulin therapy with the closed-loop system. The knowledge that the investigators gain from this research will help us to figure out whether closed-loop therapy can work in young children, hopefully leading to better Type 1 diabetes care.
Detailed description
We will perform a randomized cross-over study of semi-closed-loop insulin therapy in children less than 7 years old with type 1 diabetes. Subjects will be admitted to the inpatient clinical research center for 48 hours. They will receive their standard home insulin therapy for one day and semi-closed-loop insulin therapy for the other day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Insulin Pump Therapy first, then Closed Loop | Active comparator | Device: Closed-loop Insulin Pump therapy, Device: Standard Insulin Pump TherapyStandard therapy day 1, Closed-Loop therapy day 2. |
| Closed Loop first, then Standard Insulin Pump Therapy | Active comparator | Device: Closed-loop Insulin Pump therapy, Device: Standard Insulin Pump TherapyClosed-loop therapy day 1, standard therapy day 2. |
Who may qualify
- Ages
- 6 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age < 7 years old
- Type 1 Diabetes (as diagnosed by outpatient endocrinologist) with duration greater than 6 months
- Treated with insulin pump therapy for greater than 6 weeks
Key exclusion criteria (2 listed)
- Any other chronic medical condition
- Weight below 10 kg as this is the minimal required weight for the amount of blood being drawn
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 Pump therapyAlso: Continuous glucose monitor and computer-linked insulin pumpSubjects insulin doses were adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon. | Device | Closed Loop first, then Standard Insulin Pump Therapy, Standard Insulin Pump Therapy first, then Closed Loop |
| Standard Insulin Pump TherapyAlso: Open-Loop TherapySubjects insulin doses followed their usual home routine. | Device | Closed Loop first, then Standard Insulin Pump Therapy, Standard Insulin Pump Therapy first, then Closed Loop |
Primary outcome
Nocturnal Glycemic Control
Time frame: Participants will be followed for the duration of the 48 hour protocol.
Time spent within target glucose range based on the glucose meter measurements between 10 PM and 8 AM. The target range is 110-200 mg/dl as this is the American Diabetes Association defined target overnight range for this age group.
3 secondary outcomes
Post-prandial Glycemic Control
Time frame: Participants will be followed for the duration of the 48 hour protocol
Number of Interventions for Hypoglycemia
Time frame: Participants will be followed for the duration of the 48 hour protocol
Pre-lunch Blood Glucose Level
Time frame: Participants will be followed for the duration of the 48 hour protocol
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23033237Dauber A, Corcia L, Safer J, Agus MS, Einis S, Steil GM. Closed-loop insulin therapy improves glycemic control in children aged <7 years: a randomized controlled trial. Diabetes Care. 2013 Feb;36(2):222-7. doi: 10.2337/dc12-1079. Epub 2012 Oct 1.
- Individual participant dataSharing planned: No
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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.
Andrew Dauber, MD principal investigator
Boston Children's Hospital
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 Insulin Pump therapy and Standard Insulin Pump Therapy in people with Type 1 Diabetes Mellitus, run by Boston Children's Hospital at 1 site in United States.
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 3 inclusion and 2 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 9 Aug 2018. 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 States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Nocturnal Glycemic Control (time frame: Participants will be followed for the duration of the 48 hour protocol.). 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 NCT01421225, 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 9 Aug 2018.