NCT02105324CompletedNot Applicable
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
Massachusetts General Hospital1 site in 1 country19 target enrollmentStarted: June 1, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 5
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Bionic Pancreas
Experimental
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.
Intervention: Bionic Pancreas (Device)
Usual Care
Experimental
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.
Intervention: Usual Care (Other)
Outcomes
Primary Outcomes
Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 5
Time Frame: Days 2 to 5 of each period
Glucose reading were taken every 5 minutes by the CGM. The CGM glucose results during Days 2 through 5 were averaged.
Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 5
Time Frame: Days 2 to 5 of each period
Glucose reading were taken every 5 minutes by the CGM. The percentage of time that the glucose concentration was less than 60 mg/dL \[3.3 millimoles/liter (mmol/L)\] during Days 2 through 5 was calculated.
Secondary Outcomes
- Mean CGMG Values(Day 1 and Days 1-5 in each period)
- Percentage of Time With CGMG Concentration by Ranges During Day 1(Day 1 of each period)
- Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5(Days 1 to 5 of each period)
- Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5(Days 2 to 5 of each period)
- Percentage of Participants With Mean CGMG Glucose <154 mg/dL(Day 1, Days 1-5, and Days 2-5 of each period)
- Percentage of Participants With Mean CGMG Glucose <169 mg/dL(Day 1, Days 1-5, and Days 2-5 of each period)
- Percentage of Participants With Mean CGMG Glucose <183 mg/dL(Day 1, Days 1-5, and Days 2-5 of each period)
- Number of CGMG Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)(Days 1-5)
- Mean Plasma Glucose Values(Day 1, Days 1 to 5, and Days 2 to 5 of each period)
- Percentage of Time With Plasma Glucose Values by Ranges on Day 1(Day 1 of each period)
- Percentage of Time With Plasma Glucose Values by Ranges on Days 1 to 5(Days 1 to 5 of each period)
- Percentage of Time With Plasma Glucose Values by Ranges on Days 2 to 5(Days 2 to 5 of each period)
- Percentage of Participants With Mean Plasma Glucose <154 mg/dL(Day 1, Days 1 to 5, and Days 2 to 5 of each period)
- Percentage of Participants With Mean Plasma Glucose <169 mg/dL(Day 1, Days 1 to 5, and Days 2 to 5 of each period)
- Percentage of Participants With Mean Plasma Glucose <183 mg/dL(Day 1, Days 1 to 5, and Days 2 to 5 of each period)
- Number of Plasma Glucose Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)(Days 1-5)
- Percentage of Days That CGM Data Was Used by Participants as Part of Their Usual Care(Day 1, Days 1-5, and Days 2-5 of the Usual Care Period)
- Number of Carbohydrate Interventions for Hypoglycemia When Plasma Glucose <70 mg/dL(Day 1, Days 1-5, and Days 2-5 of each period)
- Grams of Carbohydrate Taken for Hypoglycemia When Plasma Glucose <70 mg/dL(Day 1, Days 1-5, and Days 2-5 of each period)
- Insulin Total Daily Dose(11 days)
- Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm(Day 1, Days 1-5, and Days 2-5 of each period)
- Daily Basal Insulin Dose in the Bionic Pancreas Period(Day 1 through Day 5)
- Daily Bolus Insulin Dose in the Bionic Pancreas Period(Day 1 through Day 5)
- Carbohydrate Intake(Day 1, Days 1-5 and Days 2-5)
- Number of Unscheduled Infusion Set Changes(Days 2-5)
- Number of Bionic Pancreas Local Infusion Site Reactions(Day 1, Days 1-5 and Days 2-5)
- Mean Nausea Index Score Using a Visual Analogue Scale (VAS)(Day 1, Days 1-5, and Days 2-5 in each period)
- Number of Severe Hypoglycemic Events(Day 1, Days 1-5 and Days 2-5)
- Percentage of Time Participants Were Not Under Bionic Pancreas Control During the Bionic Pancreas Period(5 days)
- Percentage of Time Without CGM Monitoring Data(5 days)
- Change From Baseline in Body Weight(5 days)
- Reliability Index(Day 1, Days 1-5, and Days 2-5 in each period)
- List of Technical Faults Associated With the Bionic Pancreas Including Cause and Resolution(5 days)
- Number of Unscheduled CGM Sensor Changes(5 days)
- Percentage of Participants Using a Glucagon-Like Peptide-1 (GLP-1) Agonist During the Usual Care Period(5 days)
- Percentage of Participants Using Pramlintide During the Usual Care Period(5 days)
- Number of Unscheduled Infusion Set Changes(Day 1)
- Number of Unscheduled Infusion Set Changes(Days 1-5)
Investigators
Steven J. Russell, MD, PhD
Assistant Professor of Medicine
Massachusetts General Hospital
Study Sites (1)
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