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The OpenAPS_ShadowMode Study

NCT03720080 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2023-03-14

No results posted yet for this study

Summary

The "Open Artificial Pancreas System (OpenAPS)" was designed to quickly spread technology and knowledge about the construction of artificial pancreas systems to patients with diabetes without awaiting clinical regulatory approval. OpenAPS is based on a privately shared software programs and available insulin pumps and glucose sensors. OpenAPS includes a "decision making" algorithm, which issues adaptions of basal rates to insulin pumps, which represents all fundamental aspects of closed loop artificial pancreas systems. The present study aims to compare the accuracy and performance of a self-constructed OpenAPS system with the approved hybrid closed loop system Medtronic Minimed 670G.

While wearing the Medtronic Minimed 670G in automode, study participants will wear an OpenAPS system in parallel, which does calculate basal rate adaptions based on continuous glucose monitoring data and its respective algorithm. The investigators aim to recruit 15 participants in an open label, single-center, single-arm, observational study. Insulin injection will only be provided by the Medtronic 670G HCL system (Basal rate insulin). The OpenAPS system will be worn contemporaneously, calculate recommended basal rate insulin adjustments but will not inject insulin. The maximum treatment period will be 2 weeks per patient.

Conditions

  • Type1diabetes

Interventions

DEVICE

OpenAPS

A self-constructed OpenAPS system will be worn contemporaneously to a Medtronic Minimed 670G hybrid closed loop system. Both systems will calculate recommended basal rate insulin adjustments but only the Minimed 670G system will inject insulin. The maximum treatment period will be 2 weeks per patient

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Christoph Stettler, Prof MD · Inselspital, Bern University Hospital, University of Bern

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-16
Primary Completion
2019-12-01
Completion
2019-12-05

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03720080 on ClinicalTrials.gov