Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 11
| Group | Value (milligrams/deciliter (mg/dL)) | Spread |
|---|---|---|
| Bionic Pancreas | 141.2 | 9.9 |
| Usual Care | 161.5 | 28.7 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataThis trial does not test a peptide that PepBank tracks.
United States
1 trial · 1 completed · 1 with posted results
A Multicenter Study of Outpatient Automated Blood Glucose Control With a Bihormonal Bionic Pancreas
NCT02092220Apr 2014 to Dec 2016
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
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 11 days.
Active comparator
Usual Care
Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Outcomes the sponsor listed as primary.
Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 11
Time frame · Days 2 to 11 of each period
Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 2 to 11 were averaged.
Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 11
Time frame · Days 2 to 11 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 to 11 was calculated.
Mean CGMG Values
Time frame · Day 1 and Days 1 to 11 in each period
Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 1 and Days 1 to 11 were averaged.
Percentage of Time With CGMG Concentration by Ranges During Day 1
Time frame · Day 1 of each period
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)
Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11
Time frame · Days 1 to 11 of each period
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)
Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11
Time frame · Days 2 to 11 of each period
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)
Percentage of Participants With Mean CGMG < 154 mg/dl
Time frame · Day 1, Days 2 to11, Days 1 to11 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 Glycosylated Hemoglobin A1C of 7%.
Number of Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)
Time frame · Days 1-11
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 Was Used by Participants as Part of Their Usual Care
Time frame · Days 1-11 of each period
The percentage of days that participants reported the CGM device was being worn and working properly is reported.
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
Time frame · 11 days of each period
A severe hypoglycemic event is an event where the participant is unable to self-treat and requires the assistance of another person.
Number of Episodes of Symptomatic Hypoglycemia
Time frame · Day 1, Days 1 to 11 and Days 2 to 11 of each period
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.
Number of Reported Carbohydrate Interventions for Hypoglycemia
Time frame · Day 1, Days 1 to 11 and Days 2 to 11 of each period
The number of carbohydrate interventions for hypoglycemia were reported daily by the participant. The average number of carbohydrate interventions per day is reported.
Total Grams of Carbohydrate Taken for Hypoglycemia
Time frame · Day 1, Days 1 to 11 and Days 2 to 11 of each period
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.
Insulin Total Daily Dose
Time frame · Day 1, Days 1 to 11, Days 2 to 11 of each period
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
Time frame · Day 1, Days 2 to 11, Days 1 to 11 of each period
Glucagon dose level is reported in micrograms per kilogram of body mass per day (µg/kg/day).
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
Time frame · 11 days
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.
Mean Nausea Index Score Using a Visual Analog Scale (VAS)
Time frame · Day 1, Days 1 to 11, Days 2 to 11 and each individual day 2 to 11 of 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 during Days 1 to 11 and Days 2 to 11 were calculated.
Change From Baseline in Body Weight
Time frame · Baseline and Day 12 of each period
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (milligrams/deciliter (mg/dL)) | Spread |
|---|---|---|
| Bionic Pancreas | 141.2 | 9.9 |
| Usual Care | 161.5 | 28.7 |
| Group | Value (percentage of time) | Spread |
|---|---|---|
| Bionic Pancreas | 0.6 | 0.6 |
| Usual Care | 1.9 | 1.7 |
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Bionic Pancreas | 145.3 | 17.6 |
| Usual Care | 161.9 | 45.2 |
| Group | Value (percentage of time) | Spread |
|---|---|---|
| Bionic Pancreas | 0.1 | 0.3 |
| Usual Care | 0.9 | 1.5 |
| Group | Value (percentage of time) | Spread |
|---|---|---|
| Bionic Pancreas | 0.1 | 0.1 |
| Usual Care | 0.6 | 0.6 |
| Group | Value (percentage of time) | Spread |
|---|---|---|
| Bionic Pancreas | 0.1 | 0.2 |
| Usual Care | 0.6 | 0.6 |
| Group | Value (percentage of participants) |
|---|---|
| Bionic Pancreas | 79 |
| Usual Care | 59 |
| Group | Value (hypoglycemic events) | Spread |
|---|---|---|
| Bionic Pancreas | 0.58 | 0.87 |
| Usual Care | 1.0 | 1.06 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Bionic PancreasBionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days. | 0 / 41 | 0 / 41 | 41 / 41 |
| Usual CareUsual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days. | 0 / 41 | 0 / 41 | 41 / 41 |
Each cell reads participants affected / participants at risk, as the registry posted them.
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