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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Automated blood glucose control via a closed-loop bionic pancreas device.
As a comparator control, usual diabetes camp care with the participant's own insulin pump.
Massachusetts General Hospital
Boston, Massachusetts, United States
Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 5
Glucose reading were taken every 5 minutes by the CGM. The CGM glucose results during Days 2 through 5 were averaged.
Time frame: Days 2 to 5 of each period
Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 5
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.
Time frame: Days 2 to 5 of each period
Mean CGMG Values
Glucose reading were taken every 5 minutes by the CGM. The glucose results for each time frame were averaged.
Time frame: Day 1 and Days 1-5 in each period
Percentage of Time With CGMG Concentration by Ranges During Day 1
Glucose readings 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), 70-180 mg/dL (3.9 to 10.0 mmol/L), \> 180 mg/dL (10.0 mmol/L).
Time frame: Day 1 of each period
Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5
Glucose readings 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), 70-180 mg/dl (3.9 to 10.0 mmol/L), \> 180 mg/dL (10.0 mmol/L).
Time frame: Days 1 to 5 of each period
Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5
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Glucose readings 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), 70-180 mg/dl (3.9 to 10.0 mmol/L), \> 180 mg/dL (10.0 mmol/L).
Time frame: Days 2 to 5 of each period
Percentage of Participants With Mean CGMG Glucose <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 Hemoglobin A1C of 7.0%.
Time frame: Day 1, Days 1-5, and Days 2-5 of each period
Percentage of Participants With Mean CGMG Glucose <169 mg/dL
Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 169 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.5%.
Time frame: Day 1, Days 1-5, and Days 2-5 of each period
Percentage of Participants With Mean CGMG Glucose <183 mg/dL
Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 183 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 8.0%.
Time frame: 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)
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 1-5
Mean Plasma Glucose Values
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. The plasma glucose results on Day 1, Days 1 to 5 and Days 2 to 5 were averaged.
Time frame: 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
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: \< 70 mg/dl (3.9 mmol/L), \< 60 mg/dL (3.3 mmol/L), \< 50 mg/dl (2.8 mmol/L).
Time frame: Day 1 of each period
Percentage of Time With Plasma Glucose Values by Ranges on Days 1 to 5
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: \< 70 mg/dL (3.9 mmol/L), \< 60 mg/dL (3.3 mmol/L), \< 50 mg/dL (2.8 mmol/L).
Time frame: Days 1 to 5 of each period
Percentage of Time With Plasma Glucose Values by Ranges on Days 2 to 5
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: \< 70 mg/dl (3.9 mmol/L), \< 60 mg/dL (3.3 mmol/L), \< 50 mg/dl (2.8 mmol/L).
Time frame: Days 2 to 5 of each period
Percentage of Participants With Mean Plasma Glucose <154 mg/dL
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 154 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.0%.
Time frame: Day 1, Days 1 to 5, and Days 2 to 5 of each period
Percentage of Participants With Mean Plasma Glucose <169 mg/dL
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 169 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.5%.
Time frame: Day 1, Days 1 to 5, and Days 2 to 5 of each period
Percentage of Participants With Mean Plasma Glucose <183 mg/dL
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 183 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 8.0%.
Time frame: 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)
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 1-5
Percentage of Days That CGM Data Was Used by Participants as Part of Their Usual Care
The percentage of days during the Usual Care period that participants used CGM data as part of their diabetes management.
Time frame: 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
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). Participants were given 15 grams (g) of simple carbohydrates if their plasma glucose concentration dropped below 4.4 mmol/L. These simple carbohydrates were counted as interventions for study outcomes if the plasma glucose concentration was less than 3.9 mmol/L. A second intervention of 15 g of carbohydrate was given if a repeat measurement in 15-20 min was less than 3.9 mmol/L. The total number of carbohydrate interventions are reported.
Time frame: Day 1, Days 1-5, and Days 2-5 of each period
Grams of Carbohydrate Taken for Hypoglycemia When Plasma Glucose <70 mg/dL
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). Participants were given 15 grams (g) of simple carbohydrates if their plasma glucose concentration dropped below 4.4 mmol/L. These simple carbohydrates were counted as interventions for study outcomes if the plasma glucose concentration was less than 3.9 mmol/L. A second intervention of 15 g of carbohydrate was given if a repeat measurement in 15-20 min was less than 3.9 mmol/L.
Time frame: Day 1, Days 1-5, and Days 2-5 of each period
Insulin Total Daily Dose
Insulin total daily dose is reported in units per kilogram per day (U/kg/day).
Time frame: 11 days
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 1-5, and Days 2-5 of each period
Daily Basal Insulin Dose in the Bionic Pancreas Period
The bionic pancreas automatically adapted insulin dosing to each individual's needs. When CGM data were not available (because of sensor failure or during the warm-up time after sensor replacement), the bionic pancreas automatically delivered a dose of basal insulin based on the mean basal dosing it had calculated at that time on previous days. Daily basal insulin dose is reported in units per kilogram (kg) per day (U/kg).
Time frame: Day 1 through Day 5
Daily Bolus Insulin Dose in the Bionic Pancreas Period
The first time the bionic pancreas was used in each participant, a partial meal-priming bolus based on the participant's body mass (0.05 units/kg) was delivered. After the first use, the size of the meal-priming bolus was adapted by the bionic pancreas to 75% of the 4-hour prandial insulin used for that meal type and size. Daily bolus insulin dose is reported in units per kilogram (kg) per day (U/kg).
Time frame: Day 1 through Day 5
Carbohydrate Intake
Carbohydrate intake included meals, snacks and unscheduled carbohydrates administered when a participant's blood glucose was \<80 mg/dl (or for symptoms at any glucose level). Carbohydrate intake per day was averaged and is reported in grams (g) per kilogram (kg) per day (g/kg/day).
Time frame: Day 1, Days 1-5 and Days 2-5
Number of Unscheduled Infusion Set Changes
Infusion sets for administering insulin and glucagon were placed under the skin the in the abdomen, buttocks, arms, or legs. Infusion set changes due to pain, infusion set falling out or infusion set failure are reported. Camp policy was to suspect failure of the infusion set whenever ketonemia occurred, so failures may not have actually been set failures, but rather failure to deliver enough insulin.
Time frame: Day 1
Number of Unscheduled Infusion Set Changes
Infusion sets for administering insulin and glucagon were placed under the skin the in the abdomen, buttocks, arms, or legs. Infusion set changes due to pain, infusion set falling out or infusion set failure are reported. Camp policy was to suspect failure of the infusion set whenever ketonemia occurred, so failures may not have actually been set failures, but rather failure to deliver enough insulin.
Time frame: Days 1-5
Number of Unscheduled Infusion Set Changes
Infusion sets for administering insulin and glucagon were placed under the skin the in the abdomen, buttocks, arms, or legs. Infusion set changes due to pain, infusion set falling out or infusion set failure are reported. Camp policy was to suspect failure of the infusion set whenever ketonemia occurred, so failures may not have actually been set failures, but rather failure to deliver enough insulin.
Time frame: Days 2-5
Number of Bionic Pancreas Local Infusion Site Reactions
Local infusion site reactions are defined as pain at the infusion site of the Bionic Pancreas. Itching and redness may have also been present.
Time frame: Day 1, Days 1-5 and Days 2-5
Mean Nausea Index Score Using a Visual Analogue 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 from Day 1 to Day 5 were calculated
Time frame: Day 1, Days 1-5, and Days 2-5 in each period
Number of 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: Day 1, Days 1-5 and Days 2-5
Percentage of Time Participants Were Not Under Bionic Pancreas Control During the Bionic Pancreas Period
Percentage of time that the Bionic pancreas was not functioning properly due to loss of wireless connectivity.
Time frame: 5 days
Percentage of Time Without CGM Monitoring Data
Percentage of time without CGM monitoring data is the time when the participant's CGM device lost its CGM signal.
Time frame: 5 days
Change From Baseline in Body Weight
The change in body weight collected at Day 5 of each period 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: 5 days
Reliability Index
Reliability index was calculated as the percentage of time values were actually recorded by CGM.
Time frame: 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
Time frame: 5 days
Number of Unscheduled CGM Sensor Changes
The number of time a CGM sensor was replaced due to falling out or failing to report a glucose value.
Time frame: 5 days
Percentage of Participants Using a Glucagon-Like Peptide-1 (GLP-1) Agonist During the Usual Care Period
The percentage of participants who used a GLP-1 agonist to manage their diabetes during the Usual Care period.
Time frame: 5 days
Percentage of Participants Using Pramlintide During the Usual Care Period
The percentage of participants who used pramlintide to manage their diabetes during the Usual Care period.
Time frame: 5 days