The OpenAPS_ShadowMode Study

Study Overview
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Brief Summary
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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.

Detailed Description
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Insulin titration remains a demanding challenge in the treatment of type 1 diabetes mellitus (T1DM). The two most significant advances in terms of insulin dosing where the introduction of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) sensors. CSII allows to diligently titrate hourly basal rates of insulin, which tremendously increased insulin and meal-time flexibility. CGM sensors provide continuous documentation of glycemic excursions without the need for patients' activity. The most recent development was to enable communication and data sharing between CSII and CGMS. The idea was to create an autonomous system that measured current glucose concentrations and issued an adequate insulin dose to the CSII device. These systems were entitled closed loop systems or artificial pancreas (AP). In general, APs have three components: the CSII device, a CGM sensor, and a decision-making algorithm integrated in a microprocessor. In 2006, the Juvenile Diabetes Research Foundation (JDRF) launched the AP Project and has been funding development in this area since that time. In 2013, the threshold suspend feature was approved by the American Food and Drug Administration (FDA) as part of the MiniMed 530G CSII and Enlite sensor CGM. Threshold suspend autonomously stopped basal rate insulin infusion if hypoglycaemia was imminent. It is categorized as hybrid closed loop (HCL) AP system. HCL autonomous adjusts basal rate insulin infusion yet requires active bolus application by the patient. Several trials confirmed its safety and efficacy in children and adults with type 1 diabetes. In clinical trials, general safety was high, glycemic control increased and the incidence of hypoglycaemia was significantly reduced. Based on these promising data, the FDA approved the Medtronic 670G as the first HCL automated insulin delivery system in the United States. In 2018, Medtronic 670G was approved in the European Union and in Switzerland for the treatment of patients with T1DM. In 2013, an initiative called the Open Artificial Pancreas System (OpenAPS) gained significant attention in the diabetes community.(9) OpenAPS was designed to quickly spread AP technology to patients with diabetes without awaiting clinical trials and FDA approval. OpenAPS is based on a privately shared software program, which enables access and transfer of CGM data to a data cloud, the so called Nightscout software. Soon thereafter, the Do-It-Yourself Pancreas System (DIYPS) software was created. DIYPS is a decision making algorithm for insulin delivery. DIYPS was combined with the Nightscout-software and allowed communication between Medtronic CSII and CGM sensors, data retrieval and issuance of insulin-dosing. With this update, the DIYPS system and Nightscout-software together became a hybrid closed loop AP system, better known as OpenAPS. In Switzerland, OpenAPS gained considerable interest in technique-affine patients with T1DM, and there already are patients with T1DM using openAPS at our department, despite the recommendation to use only approved medical devices. The number of patients using OpenAPS might be small at the moment but is growing, and diabetes care experts are asked to respond to this trend. It is necessary to evaluate safety of OpenAPS in diabetes, which are free of charge, to be used at your own risk, but regulate sensible parameters like insulin dosing in the treatment of diabetes. The aim of the present study is to evaluate accuracy and performance of an individually build OpenAPS in the fasting and the postprandial state and to compare each step of dose titration with the Medtronic 670G system as an approved HCL reference system. 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.

Official Title
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Observational Study to Compare Adaptions of Basal Rate Doses Using Self-build OpenAPS Artificial Pancreas Compared With Medtronic 670G Hybrid Closed Loop in Type 1 Diabetes

Conditions
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Type1diabetes

Intervention / Treatment
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* Device: OpenAPS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 670G/OpenAPS<br>Participants with Type 1 Diabetes wearing a Medtornic Minimed 670G hybrid closed loop system in parallel with a non-insulin injecting, self-constructed OpenAPS system. | Device: OpenAPS<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjustments of basal rate insulin infusion OpenAPS | Dose adjustments of basal rate insulin infusion calculated by OpenAPS during the study period | Maximum duration of 2 weeks per participant | 
| Adjustments of basal rate insulin infusion 670G | Dose adjustments of basal rate insulin infusion calculated by Minimed 670G during the study period | Maximum duration of 2 weeks per participant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes, Artificial Pancreas, Medtronic 670G, OpenAPS