Clinical trial NCT02105324: The Summer Camp Study 2: Blood Glucose Control With a Bi-Hormonal Endocrine Pancreas
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: bionic pancreas
artificial pancreas
insulin
glucagon
continuous glucose monitoring (CGM)
outpatient
insulin pump
pediatrics
children
camp
summer camp
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Boston University
First posted: 2014-04-07
Enrollment: 19
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 5
timeFrame: Days 2 to 5 of each period
measure: Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 5
timeFrame: Days 2 to 5 of each period
Secondary outcomes:
measure: Mean CGMG Values
timeFrame: Day 1 and Days 1-5 in each period
measure: Percentage of Time With CGMG Concentration by Ranges During Day 1
timeFrame: Day 1 of each period
measure: Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5
timeFrame: Days 1 to 5 of each period
measure: Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5
timeFrame: Days 2 to 5 of each period
measure: Percentage of Participants With Mean CGMG Glucose <154 mg/dL
timeFrame: Day 1, Days 1-5, and Days 2-5 of each period
measure: Percentage of Participants With Mean CGMG Glucose <169 mg/dL
timeFrame: Day 1, Days 1-5, and Days 2-5 of each period
measure: Percentage of Participants With Mean CGMG Glucose <183 mg/dL
timeFrame: Day 1, Days 1-5, and Days 2-5 of each period
measure: Number of CGMG Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)
timeFrame: Days 1-5
measure: Mean Plasma Glucose Values
timeFrame: Day 1, Days 1 to 5, and Days 2 to 5 of each period
measure: Percentage of Time With Plasma Glucose Values by Ranges on Day 1
timeFrame: Day 1 of each period
measure: Percentage of Time With Plasma Glucose Values by Ranges on Days 1 to 5
timeFrame: Days 1 to 5 of each period
measure: Percentage of Time With Plasma Glucose Values by Ranges on Days 2 to 5
timeFrame: Days 2 to 5 of each period
measure: Percentage of Participants With Mean Plasma Glucose <154 mg/dL
timeFrame: Day 1, Days 1 to 5, and Days 2 to 5 of each period
measure: Percentage of Participants With Mean Plasma Glucose <169 mg/dL
timeFrame: Day 1, Days 1 to 5, and Days 2 to 5 of each period
measure: Percentage of Participants With Mean Plasma Glucose <183 mg/dL
timeFrame: Day 1, Days 1 to 5, and Days 2 to 5 of each period
measure: Number of Plasma Glucose Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)
timeFrame: Days 1-5
measure: Percentage of Days That CGM Data Was Used by Participants as Part of Their Usual Care
timeFrame: Day 1, Days 1-5, and Days 2-5 of the Usual Care Period
measure: Number of Carbohydrate Interventions for Hypoglycemia When Plasma Glucose <70 mg/dL
timeFrame: Day 1, Days 1-5, and Days 2-5 of each period
measure: Grams of Carbohydrate Taken for Hypoglycemia When Plasma Glucose <70 mg/dL
timeFrame: Day 1, Days 1-5, and Days 2-5 of each period
measure: Insulin Total Daily Dose
timeFrame: 11 days
measure: Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm
timeFrame: Day 1, Days 1-5, and Days 2-5 of each period
measure: Daily Basal Insulin Dose in the Bionic Pancreas Period
timeFrame: Day 1 through Day 5
measure: Daily Bolus Insulin Dose in the Bionic Pancreas Period
timeFrame: Day 1 through Day 5
measure: Carbohydrate Intake
timeFrame: Day 1, Days 1-5 and Days 2-5
measure: Number of Unscheduled Infusion Set Changes
timeFrame: Day 1
measure: Number of Unscheduled Infusion Set Changes
timeFrame: Days 1-5
measure: Number of Unscheduled Infusion Set Changes
timeFrame: Days 2-5
measure: Number of Bionic Pancreas Local Infusion Site Reactions
timeFrame: Day 1, Days 1-5 and Days 2-5
measure: Mean Nausea Index Score Using a Visual Analogue Scale (VAS)
timeFrame: Day 1, Days 1-5, and Days 2-5 in each period
measure: Number of Severe Hypoglycemic Events
timeFrame: Day 1, Days 1-5 and Days 2-5
measure: Percentage of Time Participants Were Not Under Bionic Pancreas Control During the Bionic Pancreas Period
timeFrame: 5 days
measure: Percentage of Time Without CGM Monitoring Data
timeFrame: 5 days
measure: Change From Baseline in Body Weight
timeFrame: 5 days
measure: Reliability Index
timeFrame: Day 1, Days 1-5, and Days 2-5 in each period
measure: List of Technical Faults Associated With the Bionic Pancreas Including Cause and Resolution
timeFrame: 5 days
measure: Number of Unscheduled CGM Sensor Changes
timeFrame: 5 days
measure: Percentage of Participants Using a Glucagon-Like Peptide-1 (GLP-1) Agonist During the Usual Care Period
timeFrame: 5 days
measure: Percentage of Participants Using Pramlintide During the Usual Care Period
timeFrame: 5 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Steven J Russell, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.