Area Over the Curve and <60 mg/dl (CGM) Measured in mg/dl *Min
| Group | Value (mg/dl *minute) | Spread |
|---|---|---|
| Glucagon-only Bionic Pancreas - Glucagon | 1066.30 | 2100.17 |
| Glucagon-only Bionic Pancreas - Placebo | 2004.80 | 3076.93 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study is to test our automated hypoglycemia prevention and treatment device (glucagon-only bionic pancreas) in subjects that have undergone post-bariatric surgery that are experiencing symptoms of hypoglycemia.
Experimental
Glucagon-only bionic pancreas - glucagon
Subjects will wear the bionic pancreas that consists of a continuous glucose monitor linked to a smartphone running a hypoglycemia prevention algorithm that doses glucagon from an insulin pump through a subcutaneous infusion set. Subjects will continue to manage any hypoglycemia that occurs according to the current recommendations of their care provider.
Placebo comparator
Glucagon-only bionic pancreas - placebo
Subjects will wear the bionic pancreas that consists of a continuous glucose monitor linked to a smartphone running a hypoglycemia prevention algorithm that doses placebo from an insulin pump through a subcutaneous infusion set. Subjects will continue to manage any hypoglycemia that occurs according to the current recommendations of their care provider.
Outcomes the sponsor listed as primary.
Area Over the Curve and <60 mg/dl (CGM) Measured in mg/dl *Min
Time frame · 14 days
The measure for area over the curve is used when an integrated assessment (e.g., a measurement of something over a specific amount of time) is more useful in understanding a phenomenon. To calculate this measure, a method of approximation is often used. One way would be to estimate the curve via curve-fitting techniques. For this outcome, using area over the curve and \<60mg/dl provides a more robust method of calculating amount of hypoglycemia (by including more severe degrees of hypoglycemia in the product of mg/dl\*min as opposed to percentage of time below 60mg/dl.
Mean Continuous Glucose Monitor (CGM) Glucose
Time frame · 2 weeks
Percentage of Time With CGM Glucose Less Than 60 mg/dl Overnight (11:00 PM - 7:00 AM)
Time frame · 14 days
Percentage of Time With CGM Glucose Less Than 60 mg/dl During Daytime ( 7:00 AM-11:00 PM)
Time frame · 14 days
Percentage of Time Spent Within the Glucose Range 70-120 mg/dl
Time frame · 14 days
Percentage of Time Spent Within the Glucose Range 70-180 mg/dl
Time frame · 14 days
Percentage of Time Spent Within the Glucose Range >180 mg/dl
Time frame · 14 days
Fraction of Time Spent Within the Glucose Range >250 mg/dl
Time frame · 2 weeks
Mean Absolute Relative Deviation (MARD) of CGM vs. All StatStrip Xpress BG Measurements
Time frame · 14 days
MARD is computed using the difference between the CGM readings and the values measured at the same time by the reference measurement system. The mean (or average) of all the absolute relative deviations produces the MARD. In this study, the reference measurement system was the StatStrip Xpress meter, to which the CGM values were compared.
Number of Carbohydrate Interventions for Hypoglycemia Per Day
Time frame · 14 days
Number of carbohydrate interventions for hypoglycemia per day calculated from daily email survey
Total Number of Grams of Carbohydrate Taken for Hypoglycemia Per Day
Time frame · 14 days
Calculated from daily email survey
Total Glucagon Dosing (mcg/kg/24 Hours)
Time frame · 2 weeks
Number of Symptomatic Hypoglycemia Events Per Day
Time frame · 14 days
Number of symptomatic hypoglycemia events per day calculated from daily email survey
Percentage of Days When Participants Correctly Guessed Intervention (Glucagon vs Placebo) Out of a Total of 14 Days.
Time frame · 2 weeks
Number of Days With Nausea
Time frame · 14 days
Number of days with nausea calculated from daily survey
Severity of Nausea on Daily E-mail Survey
Time frame · 14 days
The visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. We used a simple VAS is a straight horizontal line of fixed length measuring 0-100mm with subscale markings every 10mm. The ends are defined as the extreme limits of the parameter to be measured (nausea) orientated from the left (least severity or 0) to the right (most severity or 100mm). Subjects can mark their response anywhere from 0 to 100mm. The mean severity of nausea for the group in each arm was calculated by averaging all responses in either arm.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (mg/dl *minute) | Spread |
|---|---|---|
| Glucagon-only Bionic Pancreas - Glucagon | 1066.30 | 2100.17 |
| Glucagon-only Bionic Pancreas - Placebo | 2004.80 | 3076.93 |
| Group | Value (mg/dl) | Spread |
|---|---|---|
| Glucagon-only Bionic Pancreas - Glucagon | 112.3 | 10 |
| Glucagon-only Bionic Pancreas - Placebo | 110.2 | 11.74 |
| Group | Value (percentage of time) | Spread |
|---|---|---|
| Glucagon-only Bionic Pancreas - Glucagon | 0.93 | 1.41 |
| Glucagon-only Bionic Pancreas - Placebo | 3.95 | 5.5 |
| Group | Value (percentage of time) | Spread |
|---|---|---|
| Glucagon-only Bionic Pancreas - Glucagon | 1.43 | 2.40 |
| Glucagon-only Bionic Pancreas - Placebo | 1.47 | 1.85 |
| Group | Value (percentage of time) | Spread |
|---|---|---|
| Glucagon-only Bionic Pancreas - Glucagon | 66.53 | 13.15 |
| Glucagon-only Bionic Pancreas - Placebo | 63.41 | 15.00 |
| Group | Value (percentage of time) | Spread |
|---|---|---|
| Glucagon-only Bionic Pancreas - Glucagon | 92.67 | 7.07 |
| Glucagon-only Bionic Pancreas - Placebo | 89.31 | 8.22 |
| Group | Value (percentage of time) | Spread |
|---|---|---|
| Glucagon-only Bionic Pancreas - Glucagon | 4.27 | 4.48 |
| Glucagon-only Bionic Pancreas - Placebo | 4.81 | 4.41 |
| Group | Value (percentage of time) | Spread |
|---|---|---|
| Glucagon-only Bionic Pancreas - Glucagon | 0.35 | 0.66 |
| Glucagon-only Bionic Pancreas - Placebo | 0.10 | 0.16 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Glucagon-only Bionic Pancreas - GlucagonSubjects will wear the bionic pancreas that consists of a continuous glucose monitor linked to a smartphone running a hypoglycemia prevention algorithm that doses glucagon from an insulin pump through a subcutaneous infusion set. Subjects will continue to manage any hypoglycemia that occurs according to the current recommendations of their care provider. Glucagon-only bionic pancreas - glucagon: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor. | 0 / 10 | 0 / 10 | 0 / 10 |
| Glucagon-only Bionic Pancreas - PlaceboSubjects will wear the bionic pancreas that consists of a continuous glucose monitor linked to a smartphone running a hypoglycemia prevention algorithm that doses placebo from an insulin pump through a subcutaneous infusion set. Subjects will continue to manage any hypoglycemia that occurs according to the current recommendations of their care provider. Glucagon-only bionic pancreas - placebo: A computer algorithm will automatically deliver placebo based on the signal from a minimally invasive continuous glucose monitor. | 0 / 10 | 0 / 10 | 0 / 10 |
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
Studies that cite this trial.
No study cites this trial.
Who could join, as posted.
PepBank is a research reference. Talk to a doctor before you use any peptide.
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated