Percentage of Time in Glucose Target Range (70-180 mg/dl) as Determined by Continuous Glucose Monitor (CGM) on Days 3-14
| Group | Value (percentage of time spent in target range) | Spread |
|---|---|---|
| Usual Care | 63 | 22 |
| Insulin Only Bionic Pancreas | 75 | 11 |
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
Feasibility of Outpatient Closed Loop Control With the iLet Bionic Pancreas in Cystic Fibrosis Related Diabetes
NCT0325885326 Aug 2021 to 29 Jun 2022
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The current study is designed to test the feasibility of the a wearable bionic pancreas system that automatically delivers insulin and glucagon can provide superior regulation of glycemia versus usual care for adults and children with cystic fibrosis related diabetes.
Active comparator
Usual Care
Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm
Experimental
Insulin only bionic pancreas
Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.
Outcomes the sponsor listed as primary.
Percentage of Time in Glucose Target Range (70-180 mg/dl) as Determined by Continuous Glucose Monitor (CGM) on Days 3-14
Time frame · Days 3-14
Percentage of time spent with CGM glucose values between 70 and 180 mg/dl
Percentage of Time Spent With CGM Glucose: < 54 mg/dl
Time frame · Days 3-14
Percentage of time spent with CGM glucose in this range
Mean CGM Glucose
Time frame · Days 3-14
Average CGM glucose
Percentage of Time Spent With CGM Glucose < 70 mg/dl
Time frame · Days 3-14
Percent of time the participant spent with CGM glucose in this range
Percentage of Time Spent With CGM Glucose >180 mg/dL
Time frame · Days 3-14
The percent of time the participant spent with CGM glucose in this range
Percentage of Time Spent With CGM Glucose > 250mg/dL
Time frame · Days 3-14
The percent of time the participant spent with CGM glucose in this range
Standard Deviation
Time frame · Days 3-14
Standard deviation of participants' mean CGM glucose
Coefficient of Variation
Time frame · Days 3-14
Coefficient of variation of CGM glucose values
Number of Episodes of Self-reported Symptomatic Hypoglycemia
Time frame · Days 3-14
Number of episodes subjects reported experiencing symptoms of low blood sugar (hypoglycemia)
Number of Subjects With Mean CGMG <154 mg/dl
Time frame · Days 3-14
Number of subjects who achieve a mean CGM glucose \< 154 mg/dl, which is the estimated average glucose for a hemoglobin A1c of 7% (ADA goal for therapy)
Number of Subjects With Percentage of Time < 54 mg/dl < 1%
Time frame · Days 3-14
Number of subjects who have less than 1% percent of CGM glucose values \< 54 mg/dl
Number of Subjects With Percentage of Time < 54 mg/dl < 1% and Mean CGM Glucose < or Equal to 154 mg/dl
Time frame · Days 3-14
Number of subjects who have less than 1% percent of CGM glucose values \< 54 mg/dl and also have a mean CGM glucose that is less than or equal to 154 mg/dl
Number of Subjects With Time in Range (70-180 mg/dl) of 70% or Greater
Time frame · Days 3-14
Number of subjects who have 70% percent or more of their CGM glucose values between 70 and 180 mg/dl
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of time spent in target range) | Spread |
|---|---|---|
| Usual Care | 63 | 22 |
| Insulin Only Bionic Pancreas | 75 | 11 |
| Group | Value (percentage of time spent <54mg/dL) |
|---|---|
| Usual Care | 0.36 |
| Insulin Only Bionic Pancreas | 0.27 |
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Usual Care | 171 | 45 |
| Insulin Only Bionic Pancreas | 150 | 19 |
| Group | Value (percentage of time) |
|---|---|
| Usual Care | 1.5 |
| Insulin Only Bionic Pancreas | 1.7 |
| Group | Value (percentage of time) |
|---|---|
| Usual Care | 31 |
| Insulin Only Bionic Pancreas | 18 |
| Group | Value (percentage of time) |
|---|---|
| Usual Care | 10 |
| Insulin Only Bionic Pancreas | 3.9 |
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Usual Care | 60 | 16 |
| Insulin Only Bionic Pancreas | 54 | 15 |
| Group | Value (percentage of variability) | Spread |
|---|---|---|
| Usual Care | 35 | 6 |
| Insulin Only Bionic Pancreas | 35 | 6 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Usual CareUsual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use. | 0 / 20 | 0 / 20 | 4 / 20 |
| Insulin Only Bionic PancreasInsulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days. Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting. | 0 / 20 | 0 / 20 | 6 / 20 |
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Studies that cite this trial.
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