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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Boston University
Information provided by (Responsible Party):
Steven J. Russell, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02105324
First received: April 2, 2014
Last updated: September 10, 2015
Last verified: September 2015
  Purpose
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.

Condition Intervention Phase
Type 1 Diabetes
Device: Bi-hormonal Bionic Pancreas
Other: Usual Care
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

    By cause:

    • CGM signal loss
    • Pump communication loss
    • Pump malfunction
    • iPhone or algorithm fault

  • 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 ]
    Percent of possible values actually recorded by CGM

  • List of technical faults associated with the bionic pancreas including cause and resolution [ Time Frame: Day 1, days 1-5 and days 2-5 ]

Estimated Enrollment: 24
Study Start Date: June 2014
Estimated Study Completion Date: December 2015
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bi-hormonal Bionic Pancreas Device: Bi-hormonal Bionic Pancreas
Automated blood glucose control via a closed-loop bionic pancreas device.
Other Name: Boston University Bionic Pancreas
Active Comparator: Comparator Arm
Usual Care
Other: Usual Care
Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump.

  Eligibility

Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02105324

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Boston University
Investigators
Principal Investigator: Steven J Russell, MD PhD Massachusetts General Hospital
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven J. Russell, MD, PhD, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02105324     History of Changes
Other Study ID Numbers: 2014P000630
Study First Received: April 2, 2014
Last Updated: September 10, 2015

Keywords provided by Massachusetts General Hospital:
summer camp
bionic pancreas
artificial pancreas
insulin
glucagon
continuous glucose monitoring (CGM)
outpatient
insulin pump
pediatrics
children
camp

Additional relevant MeSH terms:
Insulin
Pancrelipase
Pancreatin
Hypoglycemic Agents
Physiological Effects of Drugs
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 22, 2017