TerminatedNot Applicable

The OpenAPS_ShadowMode Study

Stopped: Enough information was gathered in order to answer the primary research question

Switzerland10 participantsStarted 2019-05-16

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Written informed consent * Aged ≥ 18 years * T1D as defined by WHO for at least 1 year * Planned use of the Medtronic 670G HCL system Exclusion Criteria: * Type 2 diabetes mellitus * Gestational diabetes mellitus * Participation in another trial which may in the opinion of the investigator interfere with the software algorithm * Any mental condition rendering the patient incapable of giving informed consent * Any disease or condition which in the opinion of the investigator would interfere with the trial performance and/or the physical and/or psychosocial safety of the study participant

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adjustments of basal rate insulin infusion OpenAPS

Timeframe: Maximum duration of 2 weeks per participant

Adjustments of basal rate insulin infusion 670G

Timeframe: Maximum duration of 2 weeks per participant

Trial details

NCT IDNCT03720080

SponsorInsel Gruppe AG, University Hospital Bern

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-12-01

View on ClinicalTrials.gov More Type1diabetes trials