This study will test the hypothesis that a wearable bionic pancreas system that automatically delivers insulin and glucagon can provide superior regulation of glycemia versus usual care for adults with type 1 diabetes. Please note that all participants must work or attend school at one of the following campuses: Massachusetts General Hospital in Boston, MA; University of Massachusetts Medical Center in Worcester, MA; University of North Carolina in Chapel Hill, NC; Stanford University in Palo Alto, CA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Stanford University
Stanford, California, United States
Massachusetts General Hospital (MGH) Diabetes Research Center
Boston, Massachusetts, United States
UMass Medical Center
Worcester, Massachusetts, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States
Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 11
Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 2 to 11 were averaged.
Time frame: Days 2 to 11 of each period
Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 11
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 to 11 was calculated.
Time frame: Days 2 to 11 of each period
Mean CGMG Values
Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 1 and Days 1 to 11 were averaged.
Time frame: Day 1 and Days 1 to 11 in each period
Percentage of Time With CGMG Concentration by Ranges During Day 1
Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated: \< 50 mg/dL (2.8 mmol/L) \< 60 mg/dL (3.3 mmol/L) \< 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) \> 180 mg/dL (10.0 mmol/L) \> 250 mg/dL (13.9 mmol/L)
Time frame: Day 1 of each period
Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11
Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated: \< 50 mg/dL (2.8 mmol/L) \< 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) \> 180 mg/dL (10.0 mmol/L) \> 250 mg/dL (13.9 mmol/L)
Time frame: Days 1 to 11 of each period
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Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11
Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated: \< 50 mg/dL (2.8 mmol/L) \< 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) \> 180 mg/dL (10.0 mmol/L) \> 250 mg/dL (13.9 mmol/L)
Time frame: Days 2 to 11 of each period
Percentage of Participants With Mean CGMG < 154 mg/dl
Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 154 mg/dL was the estimated average glucose corresponding to a Glycosylated Hemoglobin A1C of 7%.
Time frame: Day 1, Days 2 to11, Days 1 to11 of each period
Number of Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)
A series of hypoglycemic measurements is defined as a single event until there is a break of ≥ 30 minutes between measurements below the defined thresholds of \< 70, \< 60, and \<50 mg/dL.
Time frame: Days 1-11
Percentage of Days That CGM Was Used by Participants as Part of Their Usual Care
The percentage of days that participants reported the CGM device was being worn and working properly is reported.
Time frame: Days 1-11 of each period
Glycated Albumin on Day 12
Time frame: Day 12 of each period
1,5-anhydroglucitol on Day 12
Time frame: Day 12 of each period
Anti-Insulin and Anti-Glucagon Antibodies on Day 12
Time frame: Day 12 of each period
Number of Participants With Severe Hypoglycemic Events
A severe hypoglycemic event is an event where the participant is unable to self-treat and requires the assistance of another person.
Time frame: 11 days of each period
Number of Episodes of Symptomatic Hypoglycemia
The number of episodes of symptomatic hypoglycemia were reported daily by the participant. The average number of episodes of symptomatic hypoglycemia per day was calculated.
Time frame: Day 1, Days 1 to 11 and Days 2 to 11 of each period
Number of Reported Carbohydrate Interventions for Hypoglycemia
The number of carbohydrate interventions for hypoglycemia were reported daily by the participant. The average number of carbohydrate interventions per day is reported.
Time frame: Day 1, Days 1 to 11 and Days 2 to 11 of each period
Total Grams of Carbohydrate Taken for Hypoglycemia
The total grams of carbohydrate taken for hypoglycemia as reported daily by the participant were averaged. The total number of grams of carbohydrate taken for hypoglycemia were reported daily by the participant. The total number of grams of carbohydrate taken are reported.
Time frame: Day 1, Days 1 to 11 and Days 2 to 11 of each period
Insulin Total Daily Dose
Insulin total daily dose is reported in units per kilogram per day (U/kg/day).
Time frame: Day 1, Days 1 to 11, Days 2 to 11 of each period
Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm
Glucagon dose level is reported in micrograms per kilogram of body mass per day (µg/kg/day).
Time frame: Day 1, Days 2 to 11, Days 1 to 11 of each period
Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm
Time frame: Day 1, Days 2 to 11, Days 1 to11, Overall, Daytime, Nighttime of each period
Percentage of Time Bionic Pancreas Off-line or Not Functioning Properly
Not functioning properly includes issues due to system crash, communication problems between CGM and bionic pancreas, communication problems between bionic pancreas and pumps and pump malfunction.
Time frame: 11 days
Mean Nausea Index Score Using a Visual Analog Scale (VAS)
Participants rated their nausea using a 0 to 10 centimeter (cm) VAS where 0=least severe nausea to 10=most severe nausea. The average nausea index scores during Days 1 to 11 and Days 2 to 11 were calculated.
Time frame: Day 1, Days 1 to 11, Days 2 to 11 and each individual day 2 to 11 of each period
Change From Baseline in Body Weight
The change in body weight collected at Day 12 relative to Baseline. A negative change from Baseline indicates a reduction in body weight and a positive change from Baseline indicates an increase in body weight.
Time frame: Baseline and Day 12 of each period
Change From Baseline in Hemoglobin
The change in the value of hemoglobin collected at Day 12 relative to Baseline. A negative change from Baseline indicates a reduction in hemoglobin and a positive change from Baseline indicates an increase in hemoglobin.
Time frame: Baseline and Day 12 of each period
Number of Participants With Skin Rash
Time frame: 11 days of each period