N/A
N=10
Post Bariatric Closed Loop Glucagon Trial
Hypoglycemia
Bottom Line
View on ClinicalTrials.gov: NCT02966275 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Area Over the Curve and <60 mg/dl (CGM) Measured in mg/dl *Min — 1066.30; 2004.80 mg/dl *minute
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Glucagon-only bionic pancreas - glucagon (Device); Glucagon-only bionic pancreas - placebo (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Over the Curve and <60 mg/dl (CGM) Measured in mg/dl *Min |
1066.30; 2004.80 | — |
| SECONDARY Mean Continuous Glucose Monitor (CGM) Glucose |
112.3; 110.2 | — |
| SECONDARY Percentage of Time With CGM Glucose Less Than 60 mg/dl Overnight (11:00 PM - 7:00 AM) |
0.93; 3.95 | — |
| SECONDARY Percentage of Time With CGM Glucose Less Than 60 mg/dl During Daytime ( 7:00 AM-11:00 PM) |
1.43; 1.47 | — |
| SECONDARY Percentage of Time Spent Within the Glucose Range 70-120 mg/dl |
66.53; 63.41 | — |
| SECONDARY Percentage of Time Spent Within the Glucose Range 70-180 mg/dl |
92.67; 89.31 | — |
| SECONDARY Percentage of Time Spent Within the Glucose Range >180 mg/dl |
4.27; 4.81 | — |
| SECONDARY Fraction of Time Spent Within the Glucose Range >250 mg/dl |
0.35; 0.10 | — |
| SECONDARY Mean Absolute Relative Deviation (MARD) of CGM vs. All StatStrip Xpress BG Measurements |
14.2 | — |
| SECONDARY Number of Carbohydrate Interventions for Hypoglycemia Per Day |
1.17; 1.32 | — |
| SECONDARY Total Number of Grams of Carbohydrate Taken for Hypoglycemia Per Day |
24.09; 22.56 | — |
| SECONDARY Total Glucagon Dosing (mcg/kg/24 Hours) |
8.34; 10.1 | — |
| SECONDARY Number of Symptomatic Hypoglycemia Events Per Day |
1.37; 1.56 | — |
| SECONDARY Percentage of Days When Participants Correctly Guessed Intervention (Glucagon vs Placebo) Out of a Total of 14 Days. |
1.9; 1.4 | — |
| SECONDARY Number of Days With Nausea |
1.1; 1.1 | — |
| SECONDARY Severity of Nausea on Daily E-mail Survey |
0.5; 0.5 | — |
Summary
This study is to test our automated hypoglycemia prevention and treatment device (glucagon-only bionic pancreas) in subjects that have undergone post-bariatric surgery that are experiencing symptoms of hypoglycemia.
Eligibility Criteria
Inclusion Criteria
- Age 21 years or older with a gastric bypass for more than 1 year.
- 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. Other therapies will not exclude a subject as long as the therapy is continued during the study.
- Otherwise healthy (mild chronic disease such as asthma, hypertension, and depression will be allowed if well controlled).
- Self-reported frequency of documented hypoglycemia (BG 3 drinks daily in last 30 days) or substance abuse (any use within the last 6 months of controlled substances without a prescription).
- Unwilling or unable to refrain from drinking more than two drinks in an hour or more than four drinks in a day during the trial.
- Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference.
- History of adverse reaction to glucagon (including allergy) besides nausea and vomiting.
- Unwilling or unable to completely avoid acetaminophen during the study period.
- Any factors that, in the opinion of the principal investigator, would interfere with the safe completion of the study procedures.
Data sourced from ClinicalTrials.gov (NCT02966275). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.