Overview

This trial is active, not recruiting.

Condition type 1 diabetes
Treatments bi-hormonal bionic pancreas, usual care
Phase phase 2/phase 3
Sponsor Massachusetts General Hospital
Collaborator Boston University
Start date June 2014
End date August 2014
Trial size 24 participants
Trial identifier NCT02105324, 2014P000630

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
bi-hormonal bionic pancreas Boston University Bionic Pancreas
Automated blood glucose control via a closed-loop bionic pancreas device.
(Active Comparator)
Usual Care
usual care
Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump.

Primary Outcomes

Measure
Mean CGM glucose values during days 2-5
time frame: Days 2-5
Fraction of time with CGM glucose < 60 mg/dl during days 2-5
time frame: Days 2-5

Secondary Outcomes

Measure
Mean CGM glucose
time frame: Day 1, days 1-5, and days 2-5
Fraction of time spent within CGMG ranges (<50, <60,< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl).
time frame: Day 1, days 1-5,and days 2-5
Percentage of subjects with mean CGMG < 154 mg/dl.
time frame: Day 1, days 1-5 , and days 2-5
Percentage of subjects with mean CGMG < 169 mg/dl.
time frame: Day 1, days 1-5, and days 2-5
Percentage of subjects with mean CGMG < 183 mg/dl.
time frame: Day 1, days 1-5, and days 2-5
Number of CGMG reported hypoglycemic events (< 70 mg/dl, < 60 mg/dl, <50 mg/dl).
time frame: Day 1, days 1-5, and days 2-5
Average BG determined from the scheduled StatStrip Xpress measurements.
time frame: Day 1, days 1-5, and days 2-5
Percentage of the scheduled StatStrip Xpress BG values < 70 mg/dl, < 60 mg/dl, and < 50 mg/dl.
time frame: Day 1, days 1-5, and days 2-5
Percentage of subjects with mean BG < 154 mg/dl, < 169 mg/dl, and < 183 mg/dl using the scheduled StatStrip Xpress measurements.
time frame: Day 1, days 1-5, and days 2-5
Number of hypoglycemic events (BG < 70 mg/dl, BG < 60 mg/dl, BG < 50 mg/dl) as determined from all StatStrip Xpress measurements.
time frame: Day 1, days 1-5, and days 2-5
Fraction of days CGM used by participants in the usual care arm.
time frame: Day 1, days 1-5, and days 2-5
Number of carbohydrate interventions for hypoglycemia when BG < 70 mg/dl.
time frame: Day 1, days 1-5, and days 2-5
Grams of carbohydrate taken for hypoglycemia when BG < 70 mg/dl.
time frame: Day 1, days 1-5, and days 2-5
Mean insulin total daily dose.
time frame: Day 1, days 1-5, and days 2-5
Mean glucagon total daily dose.
time frame: Day 1, days 1-5, and days 2-5
Mean daily basal insulin dose.
time frame: Day 1, days 1-5, and days 2-5
Mean daily bolus insulin dose.
time frame: Day 1, days 1-5, and days 2-5
Mean meal carbohydrate content.
time frame: Day 1, days 1-5, and days 2-5
Number of unscheduled infusion set changes.
time frame: Day 1, days 1-5, and days 2-5
Number and severity of local infusion site reactions.
time frame: Day 1, days 1-5, and days 2-5
Episodes of nausea and nausea index as determined by VAS
time frame: Day 1, days 1-5, and days 2-5
Number of severe hypoglycemic events.
time frame: Day 1, days 1-5, and days 2-5
Time subjects were not under bionic pancreas control during the bionic pancreas arm.
time frame: Day 1, days 1-5, and days 2-5
Time without CGM monitoring data during the usual care arm
time frame: Day 1, days 1-5, and day 2-5
Change in body weight from beginning to end of each study arm
time frame: Day 1, days 1-5, and days 2-5
Reliability index
time frame: Day 1, days 1-5 , and days 2-5
List of technical faults associated with the bionic pancreas including cause and resolution
time frame: Day 1, days 1-5 and days 2-5

Eligibility Criteria

Male or female participants from 6 years up to 11 years old.

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 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 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 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 RF interference - Use of oral (e.g. thiazolidinediones, biguanides, sulfonylureas, glitinides, DPP-4 inhibitors, 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

Additional Information

Official title 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
Principal investigator Steven J Russell, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.