Type 1 DiabetesNCT01833988
The Summer Camp Study: Blood Glucose Control With a Bi-Hormonal Bionic Endocrine Pancreas
A study testing Bi-hormonal Bionic Pancreas in people with Type 1 Diabetes, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers both insulin and glucagon can improved glycemic control vs. usual care for young people with type 1 diabetes 12-20 in a diabetes camp environment. Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Bi-hormonal Bionic Pancreas
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 2014
- 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 12 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 12-20 years with type 1 diabetes for at least one year.
- Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins including insulin aspart (NovoLog), insulin lispro (Humalog), and insulin glulisine (Apidra) for at least three months prior to enrollment.
- Otherwise healthy (mild chronic disease such as asthma will be allowed if well controlled that do not require medications that result in exclusion).
Who cannot join
- Unable to provide informed assent
- Unable to comply with study procedures.
- Current participation in another diabetes-related clinical trial other than one that is primarily observational in nature.
- Total daily dose (TDD) of insulin that is > 2 units/kg.
- Pregnancy (positive urine HCG), plan to become pregnant in the immediate future, or sexually active without use of contraception
- Hypoglycemia unawareness (self-reported or legal guardian report of consistent lack of hypoglycemia symptoms when BG is < 50 mg/dl)
Show all 19Show fewer
- End stage renal disease on dialysis (hemodialysis or peritoneal dialysis).
- History of prolonged QT or arrhythmia
- History of congenital heart disease or current known cardiac disease
- Acute illness (other than non-vomiting viral illness) or exacerbation of chronic illness other than type 1 diabetes at the time of the study.
- Seizure disorder or history of hypoglycemic seizures or coma in the last five years
- Untreated or inadequately treated mental illness (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year), or treatment with second generation anti-psychotic medications, which are known to affect glucose regulation.
- Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to radiofrequency interference.
- Use non-insulin, injectable (e.g. exenatide, pramlintide) or oral (e.g. thiazolidinediones, biguanides, sulfonylureas, meglitinides, dipeptidyl peptidase-4 inhibitors, acarbose)anti-diabetic medications.
- History of adverse reaction to glucagon (including allergy) besides nausea and vomiting.
- Unwilling or unable to completely avoid acetaminophen during the usual care and closed-loop BG control portions of the study.
- History of eating disorder such as anorexia, bulimia, "diabulemia" or omission of insulin to manipulate weight
- History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment
- Any factors that, in the opinion of the principal investigator, would interfere with the safe completion of the study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: The Summer Camp Study: Feasibility of Outpatient Automated Blood Glucose Control With a Bi-Hormonal Bionic Endocrine Pancreas in a Pediatric Population at the Clara Barton Diabetes Camps
This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers both insulin and glucagon can improved glycemic control vs. usual care for young people with type 1 diabetes 12-20 in a diabetes camp environment.
Read the detailed description
The bionic pancreas will be compared to usual care in a crossover design in which each volunteer will serve as his or her own control. Each volunteer will be under closed-loop glucose control for five days and usual camp level of diabetes care for five days in random order with a one day washout period in between.
- Conditions
- Type 1 Diabetes
- Being tested
- Bi-hormonal Bionic Pancreas, Usual Care
- Keywords
- bionic pancreas, artificial pancreas, insulin, glucagon, continuous glucose monitoring (CGM), outpatient, insulin pump, pediatrics, children, camp, summer camp
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance, Muscle Cramp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bi-hormonal Bionic PancreasDevice
Also called Boston University Bionic Pancreas
Automated blood glucose control via a closed-loop bionic pancreas device.
Usual CareOther
Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump.
| Study group | Role | What they receive |
|---|---|---|
| Bi-hormonal Bionic Pancreas | Experimental | Bi-hormonal Bionic Pancreas Receives: Device: Bi-hormonal Bionic Pancreas |
| Usual Care | Active comparator | Usual Care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Average Blood Glucose (BG) Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) Periods as Determined From All Scheduled HemoCue Measurements With Mean Evenly Weighted Across the Daytime and Nighttime Hours.
Measured: 1 week
Percentage of Time With a Low Plasma Glucose Reading (Less Than 70mg/dl) in the Bionic Pancreas Arm as Compared to Insulin Pump Arm
Measured: 1 week
Secondary outcomes (25)
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Average BG as Determined From All HemoCue Measurements Taken During the Day/Nighttime Including All Extra Measurements.
Difference between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in average BG as determined from all HemoCue measurements taken during the day/nighttime including all extra measurements taken before meals, taken during exercise, and taken for hypoglycemia monitoring.
Measured: 1 week
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Subjects With Mean BG < 154 mg/dl
Measured: Day 2-5
Difference in the Percentage of Study Days With Mean CGM BG </= 154 mg/dl Over the Duration of the Closed-loop Period vs. the Usual Care Period
Measured: Day 2-5
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Hypoglycemic Events (BG <70mg/dl) as Determined From HemoCue Measurements
Measured: Day 1-5
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG (Continuous Glucose Monitor) Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl)
Measured: 1 week
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean BG During Exercise
Measured: 1 week
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Severe Hypoglycemic Episodes and Nadir BG During Exercise
Measured: 1 week
Difference in Mean CGMG on Day 1 vs. Remaining Days (Days 2-5) Between Closed Loop (Bionic Pancreas Arm) and Usual Care (Insulin Pump Arm)
Measured: 1 week
Difference Between Closed-loop (Bionic Pancreas) and Open-loop (Insulin Pump) in Mean Continuous Glucose Monitoring Glucose (CGMG)
Day 2-5
Measured: Day 2-5
Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 70 mg/dl (Measure of Total Hypoglycemia Exposure)
Measured: 1 week
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Area Over the Curve and Below 50 mg/dl (Measure of Total Hypoglycemia Exposure)
Measured: 1 week
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Subjects With Mean CGMG < 154 mg/dl
Measured: 1 week
Difference Between Closed-loop and Open-loop in Mean CGMG in the Four Hour Period Following Meals
Measured: 1 week
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean CGMG During Exercise
Measured: 1 week
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values (Glycemic Variability) in Different BG Ranges.
Difference between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in standard deviation of CGMG values (glycemic variability) in different BG ranges.
%<70 70-120 70-180 %>180 %>250
Measured: 1 week
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values at Night (11:00 PM to 7:00 AM)
Measured: 1 week
Difference Between Closed-loop and Open-loop in Average BG as Determined From All HemoCue Measurements Taken During the Nighttime Including All Extra Measurements Taken for Hypoglycemia Monitoring.
Measured: 1 week
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Time Spent in Hypoglycemia (Plasma BG <Than 70 mg/dl) at Night
Measured: 1 week
Difference Between Closed-loop and Open-loop in Fraction of Time at Night Spent Within Glucose Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl)
Measured: 1 week
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean CGMG at Night
Day 2-5
Measured: Day 2-5
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl) at Night
Measured: 1 week
Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 70 mg/dl (Measure of Total Hypoglycemia Exposure) at Night
Measured: 1 week
Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 50 mg/dl (Measure of Total Hypoglycemia Exposure) at Night
Measured: 1 week
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Carbohydrate Interventions for Hypoglycemia
Measured: 1 week
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Carbohydrate Interventions for Hypoglycemia at Night
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionAug 2013
- Study completionDec 2014
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 DiabetesStudies of the same condition, open and under way.
- More trials run by Massachusetts General 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University
- Responsible party
- Principal investigator, Steven J. Russell, MD, PhD, Massachusetts General Hospital
- Investigators
- Steven J Russell, MD PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01833988
- Sponsor's protocol ID
- 2013p000561
- Status last verified
- Aug 2017
- First submitted
- 13 Apr 2013
- Last updated
- 8 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Russell SJ, El-Khatib FH, Sinha M, Magyar KL, McKeon K, Goergen LG, Balliro C, Hillard MA, Nathan DM, Damiano ER. Outpatient glycemic control with a bionic pancreas in type 1 diabetes. N Engl J Med. 2014 Jul 24;371(4):313-325. doi: 10.1056/NEJMoa1314474. Epub 2014 Jun 15.
PubMed 24931572
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Summer Camp Study: Feasibility of Outpatient Automated Blood Glucose Control With a Bi-Hormonal Bionic Endocrine Pancreas in a Pediatric Population at the Clara Barton Diabetes Camps
- ClinicalTrials.gov ID
- NCT01833988
- Acronym / sponsor ID
- 2013p000561
- Conditions
- Type 1 Diabetes
- Keywords
- bionic pancreas, artificial pancreas, insulin, glucagon, continuous glucose monitoring (CGM), outpatient, insulin pump, pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Boston University
- Study start
- Apr 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Apr 2013 (estimated)
- Results
- Posted 11 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers both insulin and glucagon can improved glycemic control vs. usual care for young people with type 1 diabetes 12-20 in a diabetes camp environment.
Detailed description
The bionic pancreas will be compared to usual care in a crossover design in which each volunteer will serve as his or her own control. Each volunteer will be under closed-loop glucose control for five days and usual camp level of diabetes care for five days in random order with a one day washout period in between.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bi-hormonal Bionic Pancreas | Experimental | Device: Bi-hormonal Bionic PancreasBi-hormonal Bionic Pancreas |
| Usual Care | Active comparator | Other: Usual CareUsual Care |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 12-20 years with type 1 diabetes for at least one year.
- Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins including insulin aspart (NovoLog), insulin lispro (Humalog), and insulin glulisine (Apidra) for at least three months prior to enrollment.
- Otherwise healthy (mild chronic disease such as asthma will be allowed if well controlled that do not require medications that result in exclusion).
Key exclusion criteria (19 listed)
- Unable to provide informed assent
- Unable to comply with study procedures.
- Current participation in another diabetes-related clinical trial other than one that is primarily observational in nature.
- Total daily dose (TDD) of insulin that is > 2 units/kg.
- Pregnancy (positive urine HCG), plan to become pregnant in the immediate future, or sexually active without use of contraception
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 |
|---|---|---|
| Bi-hormonal Bionic PancreasAlso: Boston University Bionic PancreasAutomated blood glucose control via a closed-loop bionic pancreas device. | Device | Bi-hormonal Bionic Pancreas |
| Usual CareComparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump. | Other | Usual Care |
Primary outcome
Difference in Average Blood Glucose (BG) Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) Periods as Determined From All Scheduled HemoCue Measurements With Mean Evenly Weighted Across the Daytime and Nighttime Hours.
Time frame: 1 week
Percentage of Time With a Low Plasma Glucose Reading (Less Than 70mg/dl) in the Bionic Pancreas Arm as Compared to Insulin Pump Arm
Time frame: 1 week
25 secondary outcomes
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Average BG as Determined From All HemoCue Measurements Taken During the Day/Nighttime Including All Extra Measurements.
Time frame: 1 week
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Subjects With Mean BG < 154 mg/dl
Time frame: Day 2-5
Difference in the Percentage of Study Days With Mean CGM BG </= 154 mg/dl Over the Duration of the Closed-loop Period vs. the Usual Care Period
Time frame: Day 2-5
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Hypoglycemic Events (BG <70mg/dl) as Determined From HemoCue Measurements
Time frame: Day 1-5
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG (Continuous Glucose Monitor) Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl)
Time frame: 1 week
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean BG During Exercise
Time frame: 1 week
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Severe Hypoglycemic Episodes and Nadir BG During Exercise
Time frame: 1 week
Difference in Mean CGMG on Day 1 vs. Remaining Days (Days 2-5) Between Closed Loop (Bionic Pancreas Arm) and Usual Care (Insulin Pump Arm)
Time frame: 1 week
Difference Between Closed-loop (Bionic Pancreas) and Open-loop (Insulin Pump) in Mean Continuous Glucose Monitoring Glucose (CGMG)
Time frame: Day 2-5
Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 70 mg/dl (Measure of Total Hypoglycemia Exposure)
Time frame: 1 week
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Area Over the Curve and Below 50 mg/dl (Measure of Total Hypoglycemia Exposure)
Time frame: 1 week
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Subjects With Mean CGMG < 154 mg/dl
Time frame: 1 week
Difference Between Closed-loop and Open-loop in Mean CGMG in the Four Hour Period Following Meals
Time frame: 1 week
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean CGMG During Exercise
Time frame: 1 week
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values (Glycemic Variability) in Different BG Ranges.
Time frame: 1 week
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values at Night (11:00 PM to 7:00 AM)
Time frame: 1 week
Difference Between Closed-loop and Open-loop in Average BG as Determined From All HemoCue Measurements Taken During the Nighttime Including All Extra Measurements Taken for Hypoglycemia Monitoring.
Time frame: 1 week
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Time Spent in Hypoglycemia (Plasma BG <Than 70 mg/dl) at Night
Time frame: 1 week
Difference Between Closed-loop and Open-loop in Fraction of Time at Night Spent Within Glucose Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl)
Time frame: 1 week
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean CGMG at Night
Time frame: Day 2-5
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl) at Night
Time frame: 1 week
Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 70 mg/dl (Measure of Total Hypoglycemia Exposure) at Night
Time frame: 1 week
Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 50 mg/dl (Measure of Total Hypoglycemia Exposure) at Night
Time frame: 1 week
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Carbohydrate Interventions for Hypoglycemia
Time frame: 1 week
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Carbohydrate Interventions for Hypoglycemia at Night
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24931572Russell SJ, El-Khatib FH, Sinha M, Magyar KL, McKeon K, Goergen LG, Balliro C, Hillard MA, Nathan DM, Damiano ER. Outpatient glycemic control with a bionic pancreas in type 1 diabetes. N Engl J Med. 2014 Jul 24;371(4):313-325. doi: 10.1056/NEJMoa1314474. Epub 2014 Jun 15.
- Information about this and related studiesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Steven J Russell, MD PhD principal investigator
Massachusetts General 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 Bi-hormonal Bionic Pancreas in people with Type 1 Diabetes, run by Massachusetts General 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 19 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 8 Sep 2017. 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 11 Aug 2017). 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?
Difference in Average Blood Glucose (BG) Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) Periods as Determined From All Scheduled HemoCue Measurements With Mean Evenly Weighted Across the Daytime and Nighttime Hours. (time frame: 1 week). The study lists 2 primary outcomes in all. 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 NCT01833988, 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 8 Sep 2017.