Back to resultsThe Summer Camp Study 2: Blood Glucose Control With a Bi-Hormonal Endocrine Pancreas
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bionic Pancreas
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring bionic pancreas, artificial pancreas, insulin, glucagon, continuous glucose monitoring (CGM), outpatient, insulin pump, pediatrics, children, camp, summer camp
Eligibility 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 continuous glucose monitoring (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 human chorionic gonadotropin [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 type 1 diabetes (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 radio-frequency (RF) interference
- Use of oral (e.g. thiazolidinediones, biguanides, sulfonylureas, glitinides, dipeptidyl peptidase 4 (DPP-4) inhibitors, sodium-glucose linked transporter 2 (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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Bionic Pancreas
Usual Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Mean CGMG Values
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
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
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
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
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
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
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)
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
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
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
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
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
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
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
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)
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
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
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
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
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
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
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
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
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
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 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.
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.
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.
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
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.
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.
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.
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.
Reliability Index
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
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.
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.
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.
Full Information
NCT ID
NCT02105324
First Posted
April 2, 2014
Last Updated
October 19, 2017
Sponsor
Massachusetts General Hospital
Collaborators
Boston University
1. Study Identification
Unique Protocol Identification Number
NCT02105324
Brief Title
The Summer Camp Study 2: Blood Glucose Control With a Bi-Hormonal Endocrine Pancreas
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Boston University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
bionic pancreas, artificial pancreas, insulin, glucagon, continuous glucose monitoring (CGM), outpatient, insulin pump, pediatrics, children, camp, summer camp
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bionic Pancreas
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Bionic Pancreas
Other Intervention Name(s)
Boston University Bionic Pancreas
Intervention Description
Automated blood glucose control via a closed-loop bionic pancreas device.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
As a comparator control, usual diabetes camp care with the participant's own insulin pump.
Primary Outcome Measure Information:
Title
Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 5
Description
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
Title
Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 5
Description
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
Secondary Outcome Measure Information:
Title
Mean CGMG Values
Description
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
Title
Percentage of Time With CGMG Concentration by Ranges During Day 1
Description
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
Title
Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5
Description
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
Title
Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5
Description
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
Title
Percentage of Participants With Mean CGMG Glucose <154 mg/dL
Description
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
Title
Percentage of Participants With Mean CGMG Glucose <169 mg/dL
Description
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
Title
Percentage of Participants With Mean CGMG Glucose <183 mg/dL
Description
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
Title
Number of CGMG Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)
Description
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
Title
Mean Plasma Glucose Values
Description
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
Title
Percentage of Time With Plasma Glucose Values by Ranges on Day 1
Description
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
Title
Percentage of Time With Plasma Glucose Values by Ranges on Days 1 to 5
Description
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
Title
Percentage of Time With Plasma Glucose Values by Ranges on Days 2 to 5
Description
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
Title
Percentage of Participants With Mean Plasma Glucose <154 mg/dL
Description
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
Title
Percentage of Participants With Mean Plasma Glucose <169 mg/dL
Description
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
Title
Percentage of Participants With Mean Plasma Glucose <183 mg/dL
Description
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
Title
Number of Plasma Glucose Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)
Description
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
Title
Percentage of Days That CGM Data Was Used by Participants as Part of Their Usual Care
Description
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
Title
Number of Carbohydrate Interventions for Hypoglycemia When Plasma Glucose <70 mg/dL
Description
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
Title
Grams of Carbohydrate Taken for Hypoglycemia When Plasma Glucose <70 mg/dL
Description
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
Title
Insulin Total Daily Dose
Description
Insulin total daily dose is reported in units per kilogram per day (U/kg/day).
Time Frame
11 days
Title
Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm
Description
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
Title
Daily Basal Insulin Dose in the Bionic Pancreas Period
Description
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
Title
Daily Bolus Insulin Dose in the Bionic Pancreas Period
Description
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
Title
Carbohydrate Intake
Description
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
Title
Number of Unscheduled Infusion Set Changes
Description
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
Title
Number of Unscheduled Infusion Set Changes
Description
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
Title
Number of Unscheduled Infusion Set Changes
Description
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
Title
Number of Bionic Pancreas Local Infusion Site Reactions
Description
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
Title
Mean Nausea Index Score Using a Visual Analogue Scale (VAS)
Description
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
Title
Number of Severe Hypoglycemic Events
Description
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
Title
Percentage of Time Participants Were Not Under Bionic Pancreas Control During the Bionic Pancreas Period
Description
Percentage of time that the Bionic pancreas was not functioning properly due to loss of wireless connectivity.
Time Frame
5 days
Title
Percentage of Time Without CGM Monitoring Data
Description
Percentage of time without CGM monitoring data is the time when the participant's CGM device lost its CGM signal.
Time Frame
5 days
Title
Change From Baseline in Body Weight
Description
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
Title
Reliability Index
Description
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
Title
List of Technical Faults Associated With the Bionic Pancreas Including Cause and Resolution
Time Frame
5 days
Title
Number of Unscheduled CGM Sensor Changes
Description
The number of time a CGM sensor was replaced due to falling out or failing to report a glucose value.
Time Frame
5 days
Title
Percentage of Participants Using a Glucagon-Like Peptide-1 (GLP-1) Agonist During the Usual Care Period
Description
The percentage of participants who used a GLP-1 agonist to manage their diabetes during the Usual Care period.
Time Frame
5 days
Title
Percentage of Participants Using Pramlintide During the Usual Care Period
Description
The percentage of participants who used pramlintide to manage their diabetes during the Usual Care period.
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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 continuous glucose monitoring (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 human chorionic gonadotropin [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 type 1 diabetes (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 radio-frequency (RF) interference
Use of oral (e.g. thiazolidinediones, biguanides, sulfonylureas, glitinides, dipeptidyl peptidase 4 (DPP-4) inhibitors, sodium-glucose linked transporter 2 (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven J Russell, MD PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26850709
Citation
Russell SJ, Hillard MA, Balliro C, Magyar KL, Selagamsetty R, Sinha M, Grennan K, Mondesir D, Ekhlaspour L, Zheng H, Damiano ER, El-Khatib FH. Day and night glycaemic control with a bionic pancreas versus conventional insulin pump therapy in preadolescent children with type 1 diabetes: a randomised crossover trial. Lancet Diabetes Endocrinol. 2016 Mar;4(3):233-243. doi: 10.1016/S2213-8587(15)00489-1. Epub 2016 Feb 3. Erratum In: Lancet Diabetes Endocrinol. 2018 Mar;6(3):e3.
Results Reference
derived
Links:
URL
http://www.bionicpancreas.org
Description
Information about this and related studies
Learn more about this trial
The Summer Camp Study 2: Blood Glucose Control With a Bi-Hormonal Endocrine Pancreas
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