N/A
Completed N=78
Overnight Closed Loop Study in U.S.
Source: ClinicalTrials.gov NCT01857973 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Percentage of Time in Euglycemic Range - Phase 3 (Closed-loop Using the NGP Pump Platform) — 69.3 percentage of time
Summary
This is a multicenter feasibility study. Up to 85 subjects will be enrolled in the study. The goal of the study is to demonstrate that the Hybrid Closed Loop (HCL) System is safe to be used in an even larger study outside of hospital.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Time in Euglycemic Range - Phase 3 (Closed-loop Using the NGP Pump Platform) |
69.3 | — |
| SECONDARY Percentage of Time in Euglycemic Range - Exploratory A Phase |
90.7 | — |
| SECONDARY Number of Subject With YSI (Yellow Spring Instrument) Dipped Below 50mg/dL - Exploratory B Phase |
5 | — |
| SECONDARY Number of Subject Under-calibrated to Introduce a Persistent Under-reading Sensor Measurement Bias- Phase 1 |
13 | — |
| SECONDARY Percentage of Time in Euglycemic Range - Phase 2 |
65.8 | — |
| SECONDARY Percentage of Time in Euglycemic Range - Phase 4 |
76.1 | — |
| SECONDARY Percentage of Time in Euglycemic Range - Phase 6 |
60 | — |
| SECONDARY Percentage of Time in Euglycemic Range - Phase 7 |
60 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is 2-75 years of age at time of screening
- A clinical diagnosis of type 1 diabetes as determined by either medical record or source documentation from qualified individual to make medical diagnosis
Exclusion Criteria that are Based on Demands of In-Clinic Study Procedures :
- Pump therapy for greater than 6 months with use of real time CGM for any period of time (ie. one day) 3 months prior to screening
- Adequate venous access as assessed by investigator or appropriate staff
- Subject should have an established insulin carbohydrate and insulin sensitivity ratio.
- Subject reports at the time of screening that their average fasting glucose is 60 mg/dL - 200 mg/dL
- Subject reports at the time of screening that their average total daily insulin dose is 15 units - 110 units. (Insulin pump memory for this information may be used)
Data sourced from ClinicalTrials.gov (NCT01857973). 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.