Trial Outcomes & Findings for Post Bariatric Closed Loop Glucagon Trial (NCT NCT02966275)

NCT ID: NCT02966275

Last Updated: 2018-12-13

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2018-12-13

Participant Flow

10 participants were enrolled in the trial and participated in the study

Participant milestones

Measure	Glucagon-only Bionic Pancreas Subjects will use the device every day and will fill the reservoir daily with glucagon or placebo (randomized, double blinded allocation for each day). Participants would be on glucagon or placebo for either 1 day or 2 days and then switch to the alternate arm. They could not be on the same arm for more than 2 days in a row. Glucagon-only Bionic Pancreas: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Post Bariatric Closed Loop Glucagon Trial

Baseline characteristics by cohort

Measure	Glucagon-only Bionic Pancreas n=10 Participants Subjects will use the device every day and will fill the reservoir daily with either glucagon or placebo (randomized, double blinded allocation for each day) for 14 days. Glucagon-only Bionic Pancreas: A computer algorithm will automatically deliver glucagon or placebo based on the signal from a minimally invasive continuous glucose monitor.
Age, Continuous	56.2 years STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Glucagon-only Bionic Pancreas - Glucagon n=10 Participants 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. Glucagon-only bionic pancreas - glucagon: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.	Glucagon-only Bionic Pancreas - Placebo n=10 Participants 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. Glucagon-only bionic pancreas - placebo: A computer algorithm will automatically deliver placebo based on the signal from a minimally invasive continuous glucose monitor.
Area Over the Curve and <60 mg/dl (CGM) Measured in mg/dl *Min	1066.30 mg/dl *minute Standard Deviation 2100.17	2004.80 mg/dl *minute Standard Deviation 3076.93

SECONDARY outcome

Timeframe: 2 weeks

Outcome measures

Measure	Glucagon-only Bionic Pancreas - Glucagon n=10 Participants 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. Glucagon-only bionic pancreas - glucagon: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.	Glucagon-only Bionic Pancreas - Placebo n=10 Participants 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. Glucagon-only bionic pancreas - placebo: A computer algorithm will automatically deliver placebo based on the signal from a minimally invasive continuous glucose monitor.
Mean Continuous Glucose Monitor (CGM) Glucose	112.3 mg/dl Standard Deviation 10	110.2 mg/dl Standard Deviation 11.74

SECONDARY outcome

Timeframe: 14 days

Outcome measures

Measure	Glucagon-only Bionic Pancreas - Glucagon n=10 Participants 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. Glucagon-only bionic pancreas - glucagon: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.	Glucagon-only Bionic Pancreas - Placebo n=10 Participants 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. Glucagon-only bionic pancreas - placebo: A computer algorithm will automatically deliver placebo based on the signal from a minimally invasive continuous glucose monitor.
Percentage of Time With CGM Glucose Less Than 60 mg/dl Overnight (11:00 PM - 7:00 AM)	0.93 percentage of time Standard Deviation 1.41	3.95 percentage of time Standard Deviation 5.5

SECONDARY outcome

Timeframe: 14 days

Outcome measures

Measure	Glucagon-only Bionic Pancreas - Glucagon n=10 Participants 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. Glucagon-only bionic pancreas - glucagon: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.	Glucagon-only Bionic Pancreas - Placebo n=10 Participants 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. Glucagon-only bionic pancreas - placebo: A computer algorithm will automatically deliver placebo based on the signal from a minimally invasive continuous glucose monitor.
Percentage of Time With CGM Glucose Less Than 60 mg/dl During Daytime ( 7:00 AM-11:00 PM)	1.43 percentage of time Standard Deviation 2.40	1.47 percentage of time Standard Deviation 1.85

SECONDARY outcome

Timeframe: 14 days

Outcome measures

Measure	Glucagon-only Bionic Pancreas - Glucagon n=10 Participants 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. Glucagon-only bionic pancreas - glucagon: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.	Glucagon-only Bionic Pancreas - Placebo n=10 Participants 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. Glucagon-only bionic pancreas - placebo: A computer algorithm will automatically deliver placebo based on the signal from a minimally invasive continuous glucose monitor.
Percentage of Time Spent Within the Glucose Range 70-120 mg/dl	66.53 percentage of time Standard Deviation 13.15	63.41 percentage of time Standard Deviation 15.00

SECONDARY outcome

Timeframe: 14 days

Outcome measures

Measure	Glucagon-only Bionic Pancreas - Glucagon n=10 Participants 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. Glucagon-only bionic pancreas - glucagon: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.	Glucagon-only Bionic Pancreas - Placebo n=10 Participants 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. Glucagon-only bionic pancreas - placebo: A computer algorithm will automatically deliver placebo based on the signal from a minimally invasive continuous glucose monitor.
Percentage of Time Spent Within the Glucose Range 70-180 mg/dl	92.67 percentage of time Standard Deviation 7.07	89.31 percentage of time Standard Deviation 8.22

SECONDARY outcome

Timeframe: 14 days

Outcome measures

Measure	Glucagon-only Bionic Pancreas - Glucagon n=10 Participants 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. Glucagon-only bionic pancreas - glucagon: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.	Glucagon-only Bionic Pancreas - Placebo n=10 Participants 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. Glucagon-only bionic pancreas - placebo: A computer algorithm will automatically deliver placebo based on the signal from a minimally invasive continuous glucose monitor.
Percentage of Time Spent Within the Glucose Range >180 mg/dl	4.27 percentage of time Standard Deviation 4.48	4.81 percentage of time Standard Deviation 4.41

SECONDARY outcome

Timeframe: 2 weeks

Outcome measures

Measure	Glucagon-only Bionic Pancreas - Glucagon n=10 Participants 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. Glucagon-only bionic pancreas - glucagon: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.	Glucagon-only Bionic Pancreas - Placebo n=10 Participants 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. Glucagon-only bionic pancreas - placebo: A computer algorithm will automatically deliver placebo based on the signal from a minimally invasive continuous glucose monitor.
Fraction of Time Spent Within the Glucose Range >250 mg/dl	0.35 percentage of time Standard Deviation 0.66	0.10 percentage of time Standard Deviation 0.16

SECONDARY outcome

Timeframe: 14 days

Population: The 2 arms are combined for this analysis as subjects switched arms either daily or every other day through the 14 days. During this period, subjects wore 2 sensors in total (1 sensor lasts 7 days). We do not expect a difference in accuracy resulting from switching arms this frequently or relating to glucagon vs placebo.

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.

Outcome measures

Measure	Glucagon-only Bionic Pancreas - Glucagon n=10 Participants 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. Glucagon-only bionic pancreas - glucagon: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.	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. Glucagon-only bionic pancreas - placebo: A computer algorithm will automatically deliver placebo based on the signal from a minimally invasive continuous glucose monitor.
Mean Absolute Relative Deviation (MARD) of CGM vs. All StatStrip Xpress BG Measurements	14.2 percent difference Standard Deviation 12.5	—

SECONDARY outcome

Timeframe: 14 days

Number of carbohydrate interventions for hypoglycemia per day calculated from daily email survey

Outcome measures

Measure	Glucagon-only Bionic Pancreas - Glucagon n=10 Participants 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. Glucagon-only bionic pancreas - glucagon: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.	Glucagon-only Bionic Pancreas - Placebo n=10 Participants 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. Glucagon-only bionic pancreas - placebo: A computer algorithm will automatically deliver placebo based on the signal from a minimally invasive continuous glucose monitor.
Number of Carbohydrate Interventions for Hypoglycemia Per Day	1.17 interventions/day Standard Deviation 1.25	1.32 interventions/day Standard Deviation 0.94

SECONDARY outcome

Timeframe: 14 days

Calculated from daily email survey

Outcome measures

Measure	Glucagon-only Bionic Pancreas - Glucagon n=10 Participants 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. Glucagon-only bionic pancreas - glucagon: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.	Glucagon-only Bionic Pancreas - Placebo n=10 Participants 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. Glucagon-only bionic pancreas - placebo: A computer algorithm will automatically deliver placebo based on the signal from a minimally invasive continuous glucose monitor.
Total Number of Grams of Carbohydrate Taken for Hypoglycemia Per Day	24.09 grams Standard Deviation 26.10	22.56 grams Standard Deviation 22.07

SECONDARY outcome

Timeframe: 2 weeks

Outcome measures

Measure	Glucagon-only Bionic Pancreas - Glucagon n=10 Participants 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. Glucagon-only bionic pancreas - glucagon: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.	Glucagon-only Bionic Pancreas - Placebo n=10 Participants 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. Glucagon-only bionic pancreas - placebo: A computer algorithm will automatically deliver placebo based on the signal from a minimally invasive continuous glucose monitor.
Total Glucagon Dosing (mcg/kg/24 Hours)	8.34 mcg/kg/day Standard Deviation 3.76	10.1 mcg/kg/day Standard Deviation 4.3

SECONDARY outcome

Timeframe: 14 days

Number of symptomatic hypoglycemia events per day calculated from daily email survey

Outcome measures

Measure	Glucagon-only Bionic Pancreas - Glucagon n=10 Participants 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. Glucagon-only bionic pancreas - glucagon: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.	Glucagon-only Bionic Pancreas - Placebo n=10 Participants 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. Glucagon-only bionic pancreas - placebo: A computer algorithm will automatically deliver placebo based on the signal from a minimally invasive continuous glucose monitor.
Number of Symptomatic Hypoglycemia Events Per Day	1.37 events per day Standard Deviation 1.05	1.56 events per day Standard Deviation 0.94

SECONDARY outcome

Timeframe: 2 weeks

Outcome measures

Measure	Glucagon-only Bionic Pancreas - Glucagon n=10 Participants 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. Glucagon-only bionic pancreas - glucagon: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.	Glucagon-only Bionic Pancreas - Placebo n=10 Participants 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. Glucagon-only bionic pancreas - placebo: A computer algorithm will automatically deliver placebo based on the signal from a minimally invasive continuous glucose monitor.
Percentage of Days When Participants Correctly Guessed Intervention (Glucagon vs Placebo) Out of a Total of 14 Days.	1.9 percentage of days Standard Deviation 1.5	1.4 percentage of days Standard Deviation 1.1

SECONDARY outcome

Timeframe: 14 days

Number of days with nausea calculated from daily survey

Outcome measures

Measure	Glucagon-only Bionic Pancreas - Glucagon n=10 Participants 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. Glucagon-only bionic pancreas - glucagon: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.	Glucagon-only Bionic Pancreas - Placebo n=10 Participants 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. Glucagon-only bionic pancreas - placebo: A computer algorithm will automatically deliver placebo based on the signal from a minimally invasive continuous glucose monitor.
Number of Days With Nausea	1.1 days Standard Deviation 1.6	1.1 days Standard Deviation 2.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Glucagon-only Bionic Pancreas - Glucagon n=10 Participants 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. Glucagon-only bionic pancreas - glucagon: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.	Glucagon-only Bionic Pancreas - Placebo n=10 Participants 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. Glucagon-only bionic pancreas - placebo: A computer algorithm will automatically deliver placebo based on the signal from a minimally invasive continuous glucose monitor.
Severity of Nausea on Daily E-mail Survey	0.5 millimeters Standard Deviation 0.7	0.5 millimeters Standard Deviation 0.7

Adverse Events

Glucagon-only Bionic Pancreas - Glucagon

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Glucagon-only Bionic Pancreas - Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Courtney Balliro BS, RN, CDE

MGH

Phone: 617-726-1242

Email: cballiro@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place