Primary outcomeNumber· 0 - 120 minutes following dosing
Detection/Notification of Hypoglycemia
| Group | Value (successful events) |
|---|---|
| G-Pump™ (Glucagon Infusion) | 9 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataDelivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 8 participants (actual)
- Sponsor
- Xeris Pharmaceuticals · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- Mar 2016
- Primary completion
- 5 Apr 2017
- Completion
- 1 Jun 2017
- First posted
- 11 Apr 2016 (estimated)
- Last update posted
- 30 Oct 2018
- Conditions
- Hypoglycemia · Complications of Bariatric Procedures
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201620172018
- Ph 2
Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients
NCT02733588Mar 2016 to 1 Jun 2017
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- G-Pump™ (glucagon infusion)Drug
Arms1
Experimental
G-Pump™ (glucagon infusion)
0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump
Primary outcomes1
Outcomes the sponsor listed as primary.
Detection/Notification of Hypoglycemia
Time frame · 0 - 120 minutes following dosing
Registry 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.
Secondary outcomes(3)
Number of Subjects With Severe Hypoglycemia
Time frame · 0 - 120 minutes following dosing
Registry description
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
Registry description
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
Registry description
Time glucose remains in goal range, 60-180 mg/dl, reported in minutes
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(3)
Secondary outcomeNumber· 0 - 120 minutes following dosing
Number of Subjects With Severe Hypoglycemia
| Group | Value (participants) |
|---|---|
| G-Pump™ (Glucagon Infusion) | 3 |
Secondary outcomeCount of participants· 0 - 120 minutes following dosing
Number of Subjects With Rebound Hyperglycemia
| Group | Value (Participants) |
|---|---|
| G-Pump™ (Glucagon Infusion) | 0 |
Secondary outcomeMean· 0 - 120 minutes following dosing
Glucose Time in Range
| Group | Value (Minutes) | Spread |
|---|---|---|
| G-Pump™ (Glucagon Infusion) | 113 | 11 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| 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 | 0 / 7 | 0 / 7 | 7 / 7 |
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
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedLaguna 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. PMID 29355439
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 65 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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.
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