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

Mass General Brigham

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Other: Usual Care; Device: Bionic Pancreas

Study type: Interventional

Funder types: Other

Identifiers

NCT02105324

2014P000630

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• 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)
• 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 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
• History of eating disorder such as anorexia, bulimia, or 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Bionic Pancreas

Experimental group

Description:

Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.

Treatment:

Device: Bionic Pancreas

Usual Care

Experimental group

Description:

Usual 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.

Treatment:

Other: Usual Care