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 enrollmentJune 2014

ConditionsType 1 Diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 1 Diabetes
Sponsor: Massachusetts General Hospital
Enrollment: 19
Locations: 1
Primary Endpoint: Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 5
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

June 2014

End Date

August 2014

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Massachusetts General Hospital

Responsible Party

Principal Investigator

Steven J. Russell, MD, PhD

Assistant Professor of Medicine

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

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)