Trial Outcomes & Findings for Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients (NCT NCT02733588)

Last Updated: 2018-10-30

Results Overview

Frequency with which the device controller software correctly identifies impending hypoglycemia (glucose \< 75 mg/dl) and notifies the investigator to initiate treatment. Reported as the number of successful identifications.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

0 - 120 minutes following dosing

Results posted on

2018-10-30

Participant Flow

A total of 8 patients were enrolled in the study. One subject withdrew prior to completing study procedures, leaving 7 subjects who were assigned to a treatment arm. Consistent with the number of subjects who started treatment period 1, the number enrolled is given as 7 even though demographics are presented for all 8 qualified/enrolled subjects.

Participant milestones

Participant milestones
Measure	G-Pump™ (Glucagon Infusion) 0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump G-Pump™ (glucagon infusion): 0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	G-Pump™ (Glucagon Infusion) n=8 Participants 0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump G-Pump™ (glucagon infusion): 0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump
Age, Continuous	51 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants
Months postop hypoglycemia diagnosed	41 months n=5 Participants
Months postop at study visit	116 months n=5 Participants
Hemoglobin A1c	5.7 % n=5 Participants
Preoperative Body Mass Index (BMI)	46.4 kg/m2 n=5 Participants
Current BMI	30.1 kg/m2 n=5 Participants
Delta BMI	-16.3 kg/m2 n=5 Participants
Prescribed glucose-modifying medications	6 Participants n=5 Participants
Received nutritional counseling	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0 - 120 minutes following dosing

Population: Includes all subjects who completed a study visit, including repeat visits by 2 subjects.

Outcome measures

Outcome measures
Measure	G-Pump™ (Glucagon Infusion) n=9 Participants 0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump G-Pump™ (glucagon infusion): 0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump
Detection/Notification of Hypoglycemia	9 successful events

SECONDARY outcome

Timeframe: 0 - 120 minutes following dosing

Population: Includes all subjects who completed a study visit, including repeat visits by 2 subjects.

Frequency of severe hypoglycemia defined as glucose levels below 60 mg/dl. Reported as the number of subjects with severe hypoglycemia.

Outcome measures

Outcome measures
Measure	G-Pump™ (Glucagon Infusion) n=9 Participants 0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump G-Pump™ (glucagon infusion): 0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump
Number of Subjects With Severe Hypoglycemia	3 participants

SECONDARY outcome

Timeframe: 0 - 120 minutes following dosing

Population: Includes all subjects who completed a study visit, including repeat visits by 2 subjects.

Frequency of rebound hyperglycemia defined as glucose levels above 180 mg/dl. Reported as the number of subjects with rebound hyperglycemia.

Outcome measures

Outcome measures
Measure	G-Pump™ (Glucagon Infusion) n=9 Participants 0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump G-Pump™ (glucagon infusion): 0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump
Number of Subjects With Rebound Hyperglycemia	0 Participants

SECONDARY outcome

Timeframe: 0 - 120 minutes following dosing

Population: Includes all subjects who completed a study visit, including repeat visits by 2 subjects.

Time glucose remains in goal range, 60-180 mg/dl, reported in minutes

Outcome measures

Outcome measures
Measure	G-Pump™ (Glucagon Infusion) n=9 Participants 0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump G-Pump™ (glucagon infusion): 0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump
Glucose Time in Range	113 Minutes Standard Deviation 11

Adverse Events

G-Pump™ (Glucagon Infusion)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	G-Pump™ (Glucagon Infusion) n=7 participants at risk 0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump G-Pump™ (glucagon infusion): 0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump
Gastrointestinal disorders Nausea	57.1% 4/7 • Number of events 4 • Adverse Events (AEs) were collected from enrollment until 1 day following the last study visit. Thus the total monitored period was approximately 1 month per patient.
General disorders Fatigue	28.6% 2/7 • Number of events 2 • Adverse Events (AEs) were collected from enrollment until 1 day following the last study visit. Thus the total monitored period was approximately 1 month per patient.
Nervous system disorders Lightheadedness	14.3% 1/7 • Number of events 1 • Adverse Events (AEs) were collected from enrollment until 1 day following the last study visit. Thus the total monitored period was approximately 1 month per patient.
General disorders Headache	14.3% 1/7 • Number of events 1 • Adverse Events (AEs) were collected from enrollment until 1 day following the last study visit. Thus the total monitored period was approximately 1 month per patient.
Skin and subcutaneous tissue disorders Infusion site erythema	100.0% 7/7 • Number of events 7 • Adverse Events (AEs) were collected from enrollment until 1 day following the last study visit. Thus the total monitored period was approximately 1 month per patient.
Skin and subcutaneous tissue disorders Infusion site edema	57.1% 4/7 • Number of events 4 • Adverse Events (AEs) were collected from enrollment until 1 day following the last study visit. Thus the total monitored period was approximately 1 month per patient.
Skin and subcutaneous tissue disorders Infusion site discomfort	57.1% 4/7 • Number of events 4 • Adverse Events (AEs) were collected from enrollment until 1 day following the last study visit. Thus the total monitored period was approximately 1 month per patient.
Metabolism and nutrition disorders Hypoglycemia, post-discharge	42.9% 3/7 • Number of events 3 • Adverse Events (AEs) were collected from enrollment until 1 day following the last study visit. Thus the total monitored period was approximately 1 month per patient.
Skin and subcutaneous tissue disorders Bleeding from catheter site upon pump removal	14.3% 1/7 • Number of events 1 • Adverse Events (AEs) were collected from enrollment until 1 day following the last study visit. Thus the total monitored period was approximately 1 month per patient.

Additional Information

Mary-Elizabeth Patti, MD

Joslin Diabetes Center

Phone: 617-309-2665

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place