The Summer Camp Study: Blood Glucose Control With a Bi-Hormonal Bionic Endocrine Pancreas

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Summer Camp Study 2: Blood Glucose Control With a Bi-Hormonal Endocrine Pancreas

NCT02105324

Type 1 Diabetes

COMPLETED NA

A Multicenter Study of Outpatient Automated Blood Glucose Control With a Bihormonal Bionic Pancreas

NCT02092220

Diabetes Mellitus Type 1

COMPLETED NA

Closed-Loop Glucagon Administration For Hypoglycemia Treatment

NCT02181127

Type 1 Diabetes

COMPLETED NA

Outpatient Automated Blood Glucose Control With a Bi-hormonal Bionic Endocrine Pancreas

NCT01762059

Type 1 Diabetes

COMPLETED NA

Efficacy of Closed-Loop Strategy With and Without a Learning Component in Children and Adolescents With Type 1 Diabetes at a Diabetes Camp

NCT03581968

Diabetes Type 1 Diabetes Mellitus

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bi-hormonal Bionic Pancreas

Group Type EXPERIMENTAL

Bi-hormonal Bionic Pancreas

Intervention Type DEVICE

Automated blood glucose control via a closed-loop bionic pancreas device.

Usual Care

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bi-hormonal Bionic Pancreas

Automated blood glucose control via a closed-loop bionic pancreas device.

Intervention Type DEVICE

Usual Care

Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Boston University Bionic Pancreas

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No