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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

Tracking Information
First Submitted Date  ICMJE March 30, 2016
First Posted Date  ICMJE April 11, 2016
Results First Submitted Date  ICMJE August 21, 2018
Results First Posted Date  ICMJE October 30, 2018
Last Update Posted Date October 30, 2018
Study Start Date  ICMJE March 2016
Actual Primary Completion Date April 5, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2018)
Detection/Notification of Hypoglycemia [ Time Frame: 0 - 120 minutes following dosing ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 5, 2016)
Detection/Notification of Hypoglycemia [ Time Frame: 0 - 120 minutes following dosing ]
Incidence with which the device controller software correctly identifies impending hypoglycemia (glucose < 75 mg/dl) and notifies the investigator to initiate treatment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2018)
  • Number of Subjects With Severe Hypoglycemia [ Time Frame: 0 - 120 minutes following dosing ]
    Frequency of severe hypoglycemia defined as glucose levels below 60 mg/dl. Reported as the number of subjects with severe hypoglycemia.
  • Number of Subjects With Rebound Hyperglycemia [ Time Frame: 0 - 120 minutes following dosing ]
    Frequency of rebound hyperglycemia defined as glucose levels above 180 mg/dl. Reported as the number of subjects with rebound hyperglycemia.
  • Glucose Time in Range [ Time Frame: 0 - 120 minutes following dosing ]
    Time glucose remains in goal range, 60-180 mg/dl, reported in minutes
Original Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2016)
  • Prevention of severe hypoglycemia [ Time Frame: 0 - 120 minutes following dosing ]
    Incidence of severe hypoglycemia defined as glucose levels below 60 mg/dl
  • Prevention of rebound hyperglycemia [ Time Frame: 0 - 120 minutes following dosing ]
    Incidence of rebound hyperglycemia defined as glucose levels above 180 mg/dl
  • Glucose Time in Range [ Time Frame: 0 - 120 minutes following dosing ]
    Time glucose remains in goal range, 60-180 mg/dl, reported in minutes
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients
Official Title  ICMJE A Phase 2 Proof-of-Concept Study of Sensor-Guided, Clinician-Administered Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Post-Prandial Hypoglycemia in Post-Bariatric Surgery Patients
Brief Summary The primary objective of this study is to test an optimized control system for sensor-guided (physician administered) delivery of glucagon, and test Proof-of-Concept (POC) in a clinical setting in patients with severe hypoglycemia following bariatric surgery.
Detailed Description

This is a Phase 2a, single-center, open-label, proof-of-concept study designed to test the ability of the control algorithm to detect and direct timing of G-Pump™ glucagon infused from an OmniPod® pump to prevent hypoglycemia in patients with post-bariatric hypoglycemia syndrome. While the algorithm will provide an alert as to when glucagon should be dosed to prevent hypoglycemia, there will be no automation in this clinical trial and it will ultimately be up to the physician to initiate dosing via the OmniPod® controller.

Participant on continuous glucose monitoring will arrive at the clinic and IV line will be inserted for venous access. Subject will then be asked to drink a liquid mixed meal containing 60 g of carbohydrates, e.g. Boost® Nutritional Drink, over 10 minutes. Blood samples will be collected for glucose and hormone measurement.

The open-loop system will be set to recognize low sensor glucose values, triggering an alert to the physician, who will deliver a bolus of 150 or 300 µg of glucagon via the pump, with the goal of preventing further decline in glucose values. Depending on response, a second bolus dose of 150 or 300 µg of glucagon may be administered. Plasma glucose will be measured after glucagon administration to ensure successful treatment and glucose stability, and glucagon levels will be analyzed concurrently to determine magnitude of increase above baseline. Sensors will be downloaded for subsequent analysis of appropriateness of alert timing and trigger for glucagon bolus delivery.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypoglycemia
  • Complications of Bariatric Procedures
Intervention  ICMJE Drug: G-Pump™ (glucagon infusion)
0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump
Other Name: glucagon
Study Arms  ICMJE Experimental: G-Pump™ (glucagon infusion)
0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump
Intervention: Drug: G-Pump™ (glucagon infusion)
Publications * Laguna Sanz AJ, Mulla CM, Fowler KM, Cloutier E, Goldfine AB, Newswanger B, Cummins M, Deshpande S, Prestrelski SJ, Strange P, Zisser H, Doyle FJ 3rd, Dassau E, Patti ME. Design and Clinical Evaluation of a Novel Low-Glucose Prediction Algorithm with Mini-Dose Stable Glucagon Delivery in Post-Bariatric Hypoglycemia. Diabetes Technol Ther. 2018 Feb;20(2):127-139. doi: 10.1089/dia.2017.0298.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2017)
8
Original Estimated Enrollment  ICMJE
 (submitted: April 5, 2016)
5
Actual Study Completion Date  ICMJE June 1, 2017
Actual Primary Completion Date April 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • diagnosed with ongoing post-bariatric hypoglycemia with prior episodes of neuroglycopenia, unresponsive to dietary intervention (low glycemic index, controlled carbohydrate portions) and trial of acarbose therapy at the maximally tolerated dose.
  • willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.

Exclusion Criteria:

  • documented hypoglycemia occurring in the fasting state (> 12 hours fast);
  • chronic kidney disease stage 4 or 5;
  • hepatic disease, including serum alanine aminotransferase or aspartate aminotransferase greater than or equal to 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as serum albumin < 3.0 g/dL; or serum bilirubin > 2.0;
  • congestive heart failure, New York Heart Association class II, III or IV;
  • history of myocardial infarction, unstable angina or revascularization within the past 6 months;
  • history of a cerebrovascular accident;
  • seizure disorder (other than with suspect or documented hypoglycemia);
  • active treatment with any diabetes medications except for acarbose;
  • active malignancy, except basal cell or squamous cell skin cancers;
  • personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease);
  • known insulinoma;
  • major surgical operation within 30 days prior to screening;
  • hematocrit ≤ 33%;
  • bleeding disorder, treatment with warfarin, or platelet count <50,000;
  • blood donation (1 pint of whole blood) within the past 2 months;
  • active alcohol abuse or substance abuse;
  • current administration of oral or parenteral corticosteroids;
  • pregnancy and/ or Lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 1 month after participating in the study.
  • use of an investigational drug within 30 days prior to screening.
  • there will be no involvement of special vulnerable populations such as pregnant women, prisoners, institutionalized or incarcerated individuals, or others who may be considered vulnerable populations.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02733588
Other Study ID Numbers  ICMJE XSGO-PB01
1R44DK107114-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xeris Pharmaceuticals
Study Sponsor  ICMJE Xeris Pharmaceuticals
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE Not Provided
PRS Account Xeris Pharmaceuticals
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP