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A Guide to Open-Source AID Outcomes

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From CREATE to the ADA Standards of Care, evidence confirms open-source AID systems are safe, effective, and ready for DCES support in everyday practice.

Written By: ADCES member Kathryn Alvarez, MS, ACSM-CEP, CDCES. Edited by ADCES & danatech clinical staff.

September 19, 2025

Once considered experimental, open-source automated insulin delivery (AID) systems are now gaining recognition in both research and clinical practice. As diabetes care and education specialists (DCESs), we are uniquely positioned to support individuals who choose these systems, ensuring safety, optimization, and equitable access to care.

What Do the Outcomes Show?

Over the past several years, real-world evidence published in peer-reviewed journals have demonstrated improved glycemic outcomes and high user satisfaction among people with diabetes using open-source systems such as Loop, AndroidAPS, Trio, and OpenAPS.

Key findings from published studies include:

  • Time in Range (70–180 mg/dL): Increased by ~10–15% compared to commercially-available systems
  • HbA1c: Reduced by 0.5–1.0%
  • Hypoglycemia (<70 mg/dL): Significantly reduced
  • Glycemic variability: Reduced
  • Quality of life: Improved in areas such as sleep, confidence, and diabetes burden

Landmark studies such as the CREATE Trial (Burnside et al., 2022) and the OPEN Project (Braune et al., 2021) confirm these benefits, including in pediatric and underserved populations.

Is It Safe?

The short answer, as is the case with any form of applied medical technology: Yes, when properly implemented.

Open-source applications are not FDA-approved. They are built using publicly available algorithms, refined through rigorous community testing, and rely on real-time CGM and pump integration. Studies consistently report no increase in adverse events, including severe hypoglycemia or diabetic ketoacidosis (DKA).

Safety depends on:

  • Comprehensive user education and onboarding
  • Clear understanding of system settings and limitations
  • Ongoing follow-up and access to peer/community support

Compared to commercial systems, open-source platforms demand more self-management skills and technical literacy. The trade-off is flexibility, transparency, and personalization that users say is not available in commercial systems.

What Is iAPS?

While gaining popularity, iAPS is a less established system compared with Loop, AndroidAPS, or Trio. It lacks the same level of community testing, published outcomes, and long-term safety data. DCESs should approach iAPS with caution and encourage clients to carefully consider system maturity, support availability, and reliability before adopting iAPS.

The DCES Role: Meet, Don’t Dismiss

Open-source users are not “noncompliant” or “DIYing” out of recklessness. Most choose these systems after extensive research and because commercial technologies do not fully meet their needs.

Our role as HCPs is not to build or endorse these systems, it is to support the people who use them.

HCPs can:

  • Interpret data and help optimize settings
  • Reinforce safe practices (e.g., temp targets for exercise)
  • Guide glucose pattern management

Validate lived experiences and personal goals

Growing Professional Acceptance

The 2024 ADA Standards of Care (Section 7) explicitly recognized open-source AID, stating: “Open-source AID systems can be safe and effective options when used with appropriate education and oversight.”

At the 2024 and 2025 ADA Scientific Sessions, new data further demonstrated positive outcomes across diverse populations, including groups underrepresented in commercial trials. Additionally, the 2022 international consensus statement (Kovatchev et al.) emphasized the importance of collaboration between clinicians and users, validating the role of open-source systems in modern diabetes care.

Practice Pearls for DCESs

  • Always ask which AID system a client or patient is using, not just if they are using one.
  • Understand the difference between “closed loop” and “open loop” modes.
  • Encourage data uploads to platforms such as Nightscout and Tidepool.
  • Focus on outcomes and self-efficacy, not brand or system.
  • Recommend backup plans for illness, travel, or technology failures.

Resources for Healthcare Professionals

●     AndroidAPS Documentation

●     TrioDocs

●     LoopDocs

●     Loop and Learn

Closed Loop = automated insulin delivery (algorithm controls pump directly).

  • In diabetes tech, a “closed loop” means the system automatically adjusts insulin delivery based on CGM readings, without requiring the user to manually calculate or enter doses (beyond mealtime boluses, depending on the system).
  • The loop is “closed” because the CGM → algorithm → insulin pump cycle runs continuously and directly, creating an automated feedback loop.
  • Example in open-source systems: If Loop or AndroidAPS is running in closed loop mode, the algorithm automatically increases or decreases basal insulin in real time to keep glucose in target range.

Open Loop = decision support (algorithm suggests, person acts).

  • An “open loop” means the algorithm still analyzes CGM data and makes recommendations, but the user must manually approve or enter changes into the pump.
  • The loop is “open” because the automated cycle isn’t fully closed — it requires a human decision step before insulin delivery is adjusted.
  • Example: OpenAPS in open loop mode might suggest “increase basal to X units/hour,” but the user must confirm and program that change.

FAQs

1: Are open-source AID systems safe?

Yes, when implemented with proper education and oversight. Research shows no increase in adverse events such as severe hypoglycemia or diabetic ketoacidosis (DKA). Safety depends on thorough user onboarding, understanding of system settings, and continued support from clinicians and peer communities.

2: How do open-source systems compare with commercial AID systems?

Both types improve glycemic outcomes, but open-source platforms often offer greater flexibility and personalization. The trade-off is that open-source systems require more self-management skills and technical literacy than commercial systems. Many users choose them because commercial options don’t fully meet their needs.

3: What is the role of a DCES in supporting open-source users?

DCESs are not expected to build or endorse these systems, but to support the people who use them. That includes helping interpret data, reinforcing safe practices (e.g., exercise targets, backup plans), guiding glucose pattern management, and validating personal goals. Asking which AID system a client uses is essential to providing meaningful support.

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This site and its services do not constitute the practice of medical advice, diagnosis or treatment. Always talk to your diabetes care and education specialist or health care provider for diagnosis and treatment, including your specific medical needs. If you have or suspect that you have a medical problem or condition, please contact a qualified health care professional immediately. To find a diabetes care and education specialist near you, visit the ADCES finder tool.

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