N/A
Completed N=20
Outpatient Automated Blood Glucose Control With a Bi-hormonal Bionic Endocrine Pancreas
Source: ClinicalTrials.gov NCT01762059 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Average Blood Glucose (Co-primary Outcome) — 138 mg/dL
Summary
This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers both insulin and glucagon can improved glycemic control vs. usual in the outpatient environment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Blood Glucose (Co-primary Outcome) |
138 | — |
| PRIMARY Percentage of Time Blood Glucose Values Less Than 70 mg/dl (Co-primary Outcome) |
4.8 | — |
| SECONDARY Average BG During the Closed-loop Control Period as Determined From All HemoCue Measurements Taken During the Daytime and All Scheduled GlucoScout Measurements During the Nighttime. |
138 | — |
| SECONDARY Percentage of the Subset of BG Values Less Than 70 mg/dl as Determined From All All HemoCue Measurements Taken During the Daytime and Scheduled GlucoScout Measurements Taken During the Nighttime. |
4.8 | — |
| SECONDARY Difference in the Average BG Between the Closed-loop Control Period and the Usual Care Period. |
— | — |
| SECONDARY Difference in the Percentage of the Above Subset of BG Values Between the Closed-loop Control and Usual Care Periods Less Than 70 mg/dl. |
— | — |
| SECONDARY Percentage of Subjects With Mean BG < 154 mg/dl. |
100 | — |
| SECONDARY Difference in the Percentage of Subjects With Mean BG < 154 mg/dl During the Closed-loop Period vs. the Usual Care Period. |
— | — |
| SECONDARY Number of Hypoglycemic Events as Determined From GlucoScout and HemoCue Measurements. |
— | — |
| SECONDARY Nadir BG During Exercise. |
— | — |
| SECONDARY Correlation Between Exercise Intensity and Likelihood of a Hypoglycemic Event |
— | — |
| SECONDARY Average BG During the Closed-loop Control Period as Determined From All GlucoScout Measurements Taken During the Nighttime Monitoring. |
125 | — |
| SECONDARY Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From All GlucoScout and HemoCue Measurements. |
— | — |
| SECONDARY Difference of Outcome Measures on Days 1-2 vs. on Remaining Days (Days 3-5) During the Closed-loop Period. |
— | — |
| SECONDARY Mean BG During Exercise. |
— | — |
| SECONDARY Number of Hypoglycemic Episodes During Exercise. |
— | — |
| SECONDARY Difference of Outcome Measures on Day 1 vs. Remaining Days (Days 2-5) During the Closed-loop Period. |
— | — |
Eligibility Criteria
Inclusion Criteria
- Age 21 years or older with type 1 diabetes for at least one year
- Stimulated C-peptide 1.5 U/kg
- Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception.
- Hypoglycemia unawareness (self-reported lack of hypoglycemia symptoms when BG is 3-fold upper limit of normal
- Albumin < 3 g/dl
- Body mass index less than18 or greater than 35
Data sourced from ClinicalTrials.gov (NCT01762059). 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. Informational only — not medical advice.