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

Not Applicable

Completed

Conditions: Type 1 Diabetes

Interventions: Other: Usual Care
Device: Bionic Pancreas

Registration Number: NCT02105324

Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	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.
Bionic Pancreas	Bionic Pancreas	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.

Primary Outcome Measures

Name	Time	Method
Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 5	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	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 Outcome Measures

Name	Time	Method
Mean CGMG Values	Day 1 and Days 1-5 in each period	Glucose reading were taken every 5 minutes by the CGM. The glucose results for each time frame were averaged.
Percentage of Time With CGMG Concentration by Ranges During Day 1	Day 1 of each period	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).
Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5	Days 1 to 5 of each period	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).
Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5	Days 2 to 5 of each period	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).
Percentage of Participants With Mean CGMG Glucose <154 mg/dL	Day 1, Days 1-5, and Days 2-5 of each period	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%.
Percentage of Participants With Mean CGMG Glucose <169 mg/dL	Day 1, Days 1-5, and Days 2-5 of each period	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%.
Percentage of Participants With Mean CGMG Glucose <183 mg/dL	Day 1, Days 1-5, and Days 2-5 of each period	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%.
Number of CGMG Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)	Days 1-5	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.
Mean Plasma Glucose Values	Day 1, Days 1 to 5, and Days 2 to 5 of each period	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.
Percentage of Time With Plasma Glucose Values by Ranges on Day 1	Day 1 of each period	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).
Percentage of Time With Plasma Glucose Values by Ranges on Days 1 to 5	Days 1 to 5 of each period	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).
Percentage of Time With Plasma Glucose Values by Ranges on Days 2 to 5	Days 2 to 5 of each period	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).
Percentage of Participants With Mean Plasma Glucose <154 mg/dL	Day 1, Days 1 to 5, and Days 2 to 5 of each period	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%.
Percentage of Participants With Mean Plasma Glucose <169 mg/dL	Day 1, Days 1 to 5, and Days 2 to 5 of each period	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%.
Percentage of Participants With Mean Plasma Glucose <183 mg/dL	Day 1, Days 1 to 5, and Days 2 to 5 of each period	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%.
Number of Plasma Glucose Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)	Days 1-5	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.
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	The percentage of days during the Usual Care period that participants used CGM data as part of their diabetes management.
Number of Carbohydrate Interventions for Hypoglycemia When Plasma Glucose <70 mg/dL	Day 1, Days 1-5, and Days 2-5 of each period	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.
Grams of Carbohydrate Taken for Hypoglycemia When Plasma Glucose <70 mg/dL	Day 1, Days 1-5, and Days 2-5 of each period	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.
Insulin Total Daily Dose	11 days	Insulin total daily dose is reported in units per kilogram per day (U/kg/day).
Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm	Day 1, Days 1-5, and Days 2-5 of each period	Glucagon dose level is reported in micrograms per kilogram of body mass per day (µg/kg/day).
Daily Basal Insulin Dose in the Bionic Pancreas Period	Day 1 through Day 5	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).
Daily Bolus Insulin Dose in the Bionic Pancreas Period	Day 1 through Day 5	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).
Carbohydrate Intake	Day 1, Days 1-5 and Days 2-5	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).
Number of Unscheduled Infusion Set Changes	Days 2-5	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.
Number of Bionic Pancreas Local Infusion Site Reactions	Day 1, Days 1-5 and Days 2-5	Local infusion site reactions are defined as pain at the infusion site of the Bionic Pancreas. Itching and redness may have also been present.
Mean Nausea Index Score Using a Visual Analogue Scale (VAS)	Day 1, Days 1-5, and Days 2-5 in each period	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
Number of Severe Hypoglycemic Events	Day 1, Days 1-5 and Days 2-5	A severe hypoglycemic event is an event where the participant is unable to self-treat and requires the assistance of another person.
Percentage of Time Participants Were Not Under Bionic Pancreas Control During the Bionic Pancreas Period	5 days	Percentage of time that the Bionic pancreas was not functioning properly due to loss of wireless connectivity.
Percentage of Time Without CGM Monitoring Data	5 days	Percentage of time without CGM monitoring data is the time when the participant's CGM device lost its CGM signal.
Change From Baseline in Body Weight	5 days	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.
Reliability Index	Day 1, Days 1-5, and Days 2-5 in each period	Reliability index was calculated as the percentage of time values were actually recorded by CGM.
List of Technical Faults Associated With the Bionic Pancreas Including Cause and Resolution	5 days
Number of Unscheduled CGM Sensor Changes	5 days	The number of time a CGM sensor was replaced due to falling out or failing to report a glucose value.
Percentage of Participants Using a Glucagon-Like Peptide-1 (GLP-1) Agonist During the Usual Care Period	5 days	The percentage of participants who used a GLP-1 agonist to manage their diabetes during the Usual Care period.
Percentage of Participants Using Pramlintide During the Usual Care Period	5 days	The percentage of participants who used pramlintide to manage their diabetes during the Usual Care period.