The Summer Camp Study 2: Blood Glucose Control With a Bi-Hormonal Endocrine Pancreas
The Summer Camp Study 2: Outpatient Automated Blood Glucose Control With a Bi-Hormonal Bionic Endocrine Pancreas in a Pediatric Population Ages 6-11 at the Clara Barton Diabetes Camps
1 other identifier
interventional
19
1 country
1
Brief Summary
This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers both insulin and glucagon can improve glycemic control vs. usual care for young people with type 1 diabetes ages 6-11 years old in a diabetes camp environment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2014
CompletedFirst Posted
Study publicly available on registry
April 7, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
October 20, 2017
CompletedOctober 20, 2017
October 1, 2017
2 months
April 2, 2014
October 31, 2016
October 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 5
Glucose reading were taken every 5 minutes by the CGM. The CGM glucose results during Days 2 through 5 were averaged.
Days 2 to 5 of each period
Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 5
Glucose reading were taken every 5 minutes by the CGM. The percentage of time that the glucose concentration was less than 60 mg/dL \[3.3 millimoles/liter (mmol/L)\] during Days 2 through 5 was calculated.
Days 2 to 5 of each period
Secondary Outcomes (38)
Mean CGMG Values
Day 1 and Days 1-5 in each period
Percentage of Time With CGMG Concentration by Ranges During Day 1
Day 1 of each period
Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5
Days 1 to 5 of each period
Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5
Days 2 to 5 of each period
Percentage of Participants With Mean CGMG Glucose <154 mg/dL
Day 1, Days 1-5, and Days 2-5 of each period
- +33 more secondary outcomes
Study Arms (2)
Bionic Pancreas
EXPERIMENTALBionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
Usual Care
EXPERIMENTALUsual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Interventions
Automated blood glucose control via a closed-loop bionic pancreas device.
As a comparator control, usual diabetes camp care with the participant's own insulin pump.
Eligibility Criteria
You may qualify if:
- Age 6-11 years with type 1 diabetes for at least one year
- Diabetes managed using an insulin infusion pump for ≥ three months
- Willing to wear two infusion sets and continuous glucose monitoring (CGM) sensor and change sets frequently (at least one new glucagon infusion set daily)
You may not qualify if:
- Unable to provide informed consent, informed assent or parental consent
- Unable to comply with study procedures
- Current participation in another diabetes-related clinical trial that, in the judgment of the principal investigator, will compromise the results of this study or the safety of the subject
- End stage renal disease on dialysis (hemodialysis or peritoneal dialysis)
- Pregnancy (positive urine human chorionic gonadotropin \[HCG\])
- History of liver disease that is expected to interfere with the anti-hypoglycemia action of glucagon (e.g. liver failure or cirrhosis). Other liver disease (i.e. active hepatitis, steatosis, active biliary disease, any tumor of the liver, hemochromatosis, glycogen storage disease) may exclude the subject if it causes significant compromise to liver function or may do so in an unpredictable fashion
- Personal history of cystic fibrosis, pancreatitis, or other pancreatic disease, including pancreatic tumor or insulinoma
- History of prolonged QT or arrhythmia, 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 (T1D) at the time of the study
- Seizure disorder, history of any seizure within the last two years, or ongoing treatment with anticonvulsants
- 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 radio-frequency (RF) interference
- Use of oral (e.g. thiazolidinediones, biguanides, sulfonylureas, glitinides, dipeptidyl peptidase 4 (DPP-4) inhibitors, sodium-glucose linked transporter 2 (SGLT-2) inhibitors) anti-diabetic medications
- History of adverse reaction to glucagon (including allergy) besides nausea and vomiting.
- Unwilling or unable to completely avoid acetaminophen during the comparator and bionic pancreas arms of the study
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Boston Universitycollaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
Russell SJ, Hillard MA, Balliro C, Magyar KL, Selagamsetty R, Sinha M, Grennan K, Mondesir D, Ekhlaspour L, Zheng H, Damiano ER, El-Khatib FH. Day and night glycaemic control with a bionic pancreas versus conventional insulin pump therapy in preadolescent children with type 1 diabetes: a randomised crossover trial. Lancet Diabetes Endocrinol. 2016 Mar;4(3):233-243. doi: 10.1016/S2213-8587(15)00489-1. Epub 2016 Feb 3.
PMID: 26850709DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Steven J. Russell
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Steven J Russell, MD PhD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
April 2, 2014
First Posted
April 7, 2014
Study Start
June 1, 2014
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
October 20, 2017
Results First Posted
October 20, 2017
Record last verified: 2017-10