Number of Subjects With Plasma Glucose < 60 mg/dl
| Group | Value |
|---|---|
| Bihormonal Bionic Pancreas | not posted |
| Insulin Only Bionic Pancreas | not posted |
Trial · Interventional
TerminatedNot applicableResults postedRegistry dataThis trial was stopped early.
Reason given at the registry: Lack of appropriate funds
Results were posted for this trial.
United States
1 trial · 1 stopped early · 1 with posted results
Efficacy of Glucagon In the Prevention of Hypoglycemia During Mild Exercise
NCT0321717518 Aug 2017 to 9 Mar 2018
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The study will consist of two study arms. Each arm will include a 24-96 hour outpatient run-in period prior to their exercise visit wearing the bi-hormonal bionic pancreas. In random order subjects will then complete two approximately 5-hour exercise visits, one wearing the bi-hormonal bionic pancreas and one wearing the insulin-only bionic pancreas.
Active comparator
Bihormonal Bionic Pancreas
Bihormonal bionic pancreas exercise visit - subjects will participate in the outpatient bihormonal bionic pancreas run in period, and will use the bihormonal bionic pancreas for their exercise visit at the end of the run in. The glucagon pump of the bionic pancreas will be filled with glucagon.
Placebo comparator
Insulin Only Bionic Pancreas
Insulin-only bionic pancreas exercise visit - Bihormonal bionic pancreas exercise visit - subjects will participate in the outpatient bihormonal bionic pancreas run in period, and will use the insulin-only bionic pancreas for their exercise visit at the end of the run in. The glucagon pump of the bionic pancreas will be filled with placebo (normal saline).
Outcomes the sponsor listed as primary.
Number of Subjects With Plasma Glucose < 60 mg/dl
Time frame · 1 day (last day of each study arm - exercise visit)
Number of subjects discordant between insulin-only and bihormonal bionic pancreas visits for reaching plasma glucose less than 60 mg/dl for greater than 2 consecutive measurements
Duration of Plasma Glucose < 60 mg/dl
Time frame · 1 day (last day of each study arm - exercise visit)
The amount of time the subject's plasma glucose is less than 60 mg/dl during the exercise visit
Nadir Plasma Glucose
Time frame · 1 day (last day of each study arm - exercise visit)
The lowest plasma glucose experienced during the exercise visit
Area Over the Curve and < 60 mg/dl
Time frame · 1 day (last day of each study arm - exercise visit)
The area over the plasma glucose curve but less than the 60 mg/dl threshold during exercise visit (a measure of hypoglycemic exposure)
Time From Exercise Start to Plasma Glucose < 60 mg/dl
Time frame · 1 day (last day of each study arm - exercise visit)
The time from the start of exercise to the first plasma glucose measurement \< 60 mg/dl that is reached
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value |
|---|---|
| Bihormonal Bionic Pancreas | not posted |
| Insulin Only Bionic Pancreas | not posted |
| Group | Value |
|---|---|
| Bihormonal Bionic Pancreas | not posted |
| Insulin Only Bionic Pancreas | not posted |
| Group | Value |
|---|---|
| Bihormonal Bionic Pancreas | not posted |
| Insulin Only Bionic Pancreas | not posted |
| Group | Value |
|---|---|
| Bihormonal Bionic Pancreas | not posted |
| Insulin Only Bionic Pancreas | not posted |
| Group | Value |
|---|---|
| Bihormonal Bionic Pancreas | not posted |
| Insulin Only Bionic Pancreas | not posted |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Bihormonal Bionic PancreasAdverse events for participants in the bihormonal bionic pancreas arm are reported here. | 0 / 5 | 0 / 5 | 0 / 5 |
| Insulin-only Bionic PancreasAdverse events for participants in the insulin-only bionic pancreas arm are reported here. | 0 / 5 | 0 / 5 | 0 / 5 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
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