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

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ClinicalTrials.gov Identifier: NCT02733588
Recruitment Status : Completed
First Posted : April 11, 2016
Results First Posted : October 30, 2018
Last Update Posted : October 30, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Xeris Pharmaceuticals

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hypoglycemia
Complications of Bariatric Procedures
Intervention Drug: G-Pump™ (glucagon infusion)
Enrollment 8
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title G-Pump™ (Glucagon Infusion)
Hide Arm/Group Description

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

Period Title: Overall Study
Started 7
Completed 7
Not Completed 0
Arm/Group Title G-Pump™ (Glucagon Infusion)
Hide Arm/Group Description

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 Number of Baseline Participants 8
Hide Baseline Analysis Population Description
A total of 8 subjects were enrolled into the study and demographic characteristics are provided for these 8 subjects. One subject dropped out before receiving study treatment or beginning any study procedures. A total of 7 unique subjects received treatment, and due to the iterative nature of the study, 2 subjects participated twice.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants
51
(38 to 62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
7
  87.5%
Male
1
  12.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Hispanic or Latino
1
  12.5%
Not Hispanic or Latino
7
  87.5%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
8
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
Months postop hypoglycemia diagnosed  
Mean (Full Range)
Unit of measure:  Months
Number Analyzed 8 participants
41
(12 to 150)
Months postop at study visit  
Median (Full Range)
Unit of measure:  Months
Number Analyzed 8 participants
116
(45 to 176)
Hemoglobin A1c  
Mean (Full Range)
Unit of measure:  %
Number Analyzed 8 participants
5.7
(5.4 to 5.8)
Preoperative Body Mass Index (BMI)  
Mean (Full Range)
Unit of measure:  Kg/m2
Number Analyzed 8 participants
46.4
(37.8 to 61.0)
Current BMI  
Mean (Full Range)
Unit of measure:  Kg/m2
Number Analyzed 8 participants
30.1
(24.3 to 36.8)
Delta BMI  
Mean (Full Range)
Unit of measure:  Kg/m2
Number Analyzed 8 participants
-16.3
(-36.7 to -5.2)
Prescribed glucose-modifying medications  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
6
  75.0%
Received nutritional counseling  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
7
  87.5%
1.Primary Outcome
Title Detection/Notification of Hypoglycemia
Hide Description 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.
Time Frame 0 - 120 minutes following dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who completed a study visit, including repeat visits by 2 subjects.
Arm/Group Title G-Pump™ (Glucagon Infusion)
Hide Arm/Group Description:

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 Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: successful events
9
2.Secondary Outcome
Title Number of Subjects With Severe Hypoglycemia
Hide Description Frequency of severe hypoglycemia defined as glucose levels below 60 mg/dl. Reported as the number of subjects with severe hypoglycemia.
Time Frame 0 - 120 minutes following dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who completed a study visit, including repeat visits by 2 subjects.
Arm/Group Title G-Pump™ (Glucagon Infusion)
Hide Arm/Group Description:

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 Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
3
3.Secondary Outcome
Title Number of Subjects With Rebound Hyperglycemia
Hide Description Frequency of rebound hyperglycemia defined as glucose levels above 180 mg/dl. Reported as the number of subjects with rebound hyperglycemia.
Time Frame 0 - 120 minutes following dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who completed a study visit, including repeat visits by 2 subjects.
Arm/Group Title G-Pump™ (Glucagon Infusion)
Hide Arm/Group Description:

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 Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4.Secondary Outcome
Title Glucose Time in Range
Hide Description Time glucose remains in goal range, 60-180 mg/dl, reported in minutes
Time Frame 0 - 120 minutes following dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who completed a study visit, including repeat visits by 2 subjects.
Arm/Group Title G-Pump™ (Glucagon Infusion)
Hide Arm/Group Description:

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 Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: Minutes
113  (11)
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title G-Pump™ (Glucagon Infusion)
Hide Arm/Group Description

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

All-Cause Mortality
G-Pump™ (Glucagon Infusion)
Affected / at Risk (%)
Total   0/7 (0.00%)    
Hide Serious Adverse Events
G-Pump™ (Glucagon Infusion)
Affected / at Risk (%) # Events
Total   0/7 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
G-Pump™ (Glucagon Infusion)
Affected / at Risk (%) # Events
Total   7/7 (100.00%)    
Gastrointestinal disorders   
Nausea *  4/7 (57.14%)  4
General disorders   
Fatigue *  2/7 (28.57%)  2
Headache *  1/7 (14.29%)  1
Metabolism and nutrition disorders   
Hypoglycemia, post-discharge *  3/7 (42.86%)  3
Nervous system disorders   
Lightheadedness *  1/7 (14.29%)  1
Skin and subcutaneous tissue disorders   
Infusion site erythema   7/7 (100.00%)  7
Infusion site edema   4/7 (57.14%)  4
Infusion site discomfort *  4/7 (57.14%)  4
Bleeding from catheter site upon pump removal   1/7 (14.29%)  1
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Sample size was small; gender mix, although unequal, is typical of the PBH population at Joslin. The protocol was modified at every stage to test iterations of the detection algorithm and/or increasing glucagon doses to prevent hypoglycemia.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mary-Elizabeth Patti, MD
Organization: Joslin Diabetes Center
Phone: 617-309-2665
EMail: mary.elizabeth.patti@joslin.harvard.edu
Layout table for additonal information
Responsible Party: Xeris Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02733588    
Other Study ID Numbers: XSGO-PB01
1R44DK107114-01 ( U.S. NIH Grant/Contract )
First Submitted: March 30, 2016
First Posted: April 11, 2016
Results First Submitted: August 21, 2018
Results First Posted: October 30, 2018
Last Update Posted: October 30, 2018