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
Bi-hormonal Bionic Pancreas
+ Usual Care
Autoimmune Diseases+15
+ Diabetes Mellitus
+ Endocrine System Diseases
Treatment Study
Summary
Study start date: April 1, 2013
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.32 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 12 to 20 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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) 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Massachusetts General Hospital
Boston, United StatesOpen Massachusetts General Hospital in Google Maps