INSTITUTION PROFILE / BIOSENSORS
American Diabetes Association (ADA)
The US diabetes organisation that sets out where glucose meters and CGM fit in clinical care
The ADA is a US non-profit that also serves as a professional society for health care professionals. In its annually revised clinical guideline, Standards of Care in Diabetes, it includes a chapter on "diabetes technology" covering blood glucose meters, continuous glucose monitoring (CGM) and insulin pumps, and sets out recommendations for clinicians. The ADA is not a regulator, however. It has no power to approve devices, and no power to give its recommendations legal force. The guideline itself takes regulators' decisions as its starting point, for example by recommending glucose meters that have been approved by the U.S. Food and Drug Administration (FDA). This profile looks at one question: how much influence the ADA actually has over biosensors, in terms of the kind of power it holds and how far that power reaches.
This article describes the role and reach of an organisation. It is not advice on diagnosis, treatment or the reading of any individual's measurements. The ADA itself says its recommendations are for health care professionals to apply to each person's circumstances. For choices about devices and how to use them, please consult your own health care professional.
- The ADA in 30 seconds
- What kind of body it is: the four types of influence
- What it does for biosensors
- How far its influence reaches (powers and geography)
- How the guideline is made and used
- Outlook
- Glossary, references and claim-to-source audit
1. The ADA in 30 seconds
What the ADA sets out is which devices it recommends clinicians use, and in which situations. It is not permission to sell a device. On glucose meters, Section 7 of the guideline recommends that health care professionals use only meters that the FDA (or a comparable regulator elsewhere) has approved and whose accuracy has been shown (Recommendation 7.12) Sourced. The ADA, in other words, speaks about clinical positioning on the basis of regulators' decisions, and does not set the approval criteria itself. Its influence is still considerable, because the guideline is revised every year and takes in new device types as they appear (for example, CGM sold without a prescription), becoming a yardstick for how devices are used in practice.
2. What kind of body it is: the four types of influence
Unlike the companies in this series, the institutions that appear in biosensor coverage do not make sensors. What separates them is the route by which they influence the industry, and that gives four types.
3. What it does for biosensors
The ADA's involvement with biosensors comes in two parts: the Standards of Care in Diabetes guideline, and its meetings and journals. The 2026 edition of the Standards of Care appears in Diabetes Care, volume 49, supplement 1, and was published online on 8 December 2025. Section 7, "Diabetes Technology", occupies pages S150 to S165 Sourced.
| Item | What it contains (per the ADA) | Note from this article |
|---|---|---|
| The Standards of Care as a whole | All of the ADA's current clinical practice recommendations, giving components of diabetes care, general treatment goals and tools to evaluate the quality of care. Updated annually, and online at any time when new evidence or regulatory changes, such as device approvals, warrant it. Published every year since 1989 | Each recommendation carries an evidence grade (A, B, C or E); E means expert consensus or clinical experience |
| Section 7, Diabetes Technology | Recommendations 7.1 to 7.30, covering blood glucose monitoring (BGM), CGM, insulin pumps, automated insulin delivery (AID), connected pens and apps | Changes in 2026: new recommendations on education and training by device type (7.3 split into 7.3a for CGM and 7.3b for AID), and support at school and work (7.6, 7.7) |
| Comparing meter accuracy standards (Table 7.1) | A table setting the FDA's criteria beside ISO 15197:2013. The ADA's table gives, for FDA home-use criteria, "95% within 15% and 99% within 20% across the usable range", and for ISO 15197:2013 "95% within 15 mg/dL (below 100 mg/dL) or 15% (100 mg/dL and above) of the reference, and 99% in zones A and B of the consensus error grid" | The figures are as shown in the ADA's table, not the text of the standard or the FDA guidance. The ADA also writes that meters marketed in the US must meet the standard under which they were approved, which may not be the current one, and that post-market accuracy monitoring is left to the manufacturer |
| Interfering substances (Table 7.2) | Substances and conditions that can affect meter readings (maltose, galactose, xylose, N-acetylcysteine, acetaminophen and others) and the direction of the effect | Test methods for interference are in CLSI documents (see our CLSI profile). The ADA table only lists effects |
| Types of CGM (Table 7.3) | Three types, classified with brand names: real-time CGM (rtCGM; prescription, with alarms), CGM sold over the counter (OTC-CGM; no alarms) and professional CGM used in a clinic. The ADA writes that most currently available CGM systems are designated integrated CGM (iCGM) and cleared by the FDA as class II medical devices | The table illustrates the types; it is not a product comparison |
| Glycaemic goals (Section 6) | In 2026 the figure on individualised glycaemic goals gained individualised goals for CGM metrics, based on health status and other factors | The goals are for clinicians to apply to individuals; this article does not discuss them |
| Meetings and journals | The Scientific Sessions (18 to 21 June 2027 in Washington, DC; over 12,000 researchers and clinicians attend each year). The 26th Diabetes Technology Meeting, co-hosted with the Diabetes Technology Society (DTS), 27 to 29 October 2026 in Washington, DC. The Standards of Care appear in Diabetes Care | Meetings and journals are venues for presenting and discussing research, independent of regulation and approval |
As an example of the guideline's recommendations, Section 7 includes a recommendation that CGM use be recommended from diabetes onset for people on insulin therapy and others (Recommendation 7.15, graded A for people on insulin therapy and C for those on non-insulin therapies that can cause hypoglycaemia) Sourced. This is an example of a recommendation addressed to health care professionals, not advice on how an individual should choose a device.
The ADA guideline sets no standards for materials such as electrodes, enzyme membranes or skin adhesives. What it shows instead is what becomes a problem in clinical use. Section 7, for example, includes a recommendation to assess and address skin reactions, whether irritation or allergy, to help people use devices successfully (7.19), and one to educate CGM wearers about interfering substances and other factors that can affect accuracy (7.20) Sourced. From the materials side, this means that the irritancy of skin adhesives and the response of electrodes to interfering substances are issues that clinical documents such as the ADA's also raise. We cover these from the materials side in our explainers on patch-type sensors and skin adhesives and on electrochemical sensors.
4. How far its influence reaches (powers and geography)
| Aspect | What the ADA has | What the ADA does not have |
|---|---|---|
| Powers | It drafts and publishes the recommendations in its guideline. The Professional Practice Committee updates them each year, and they go through external peer review, ADA leadership review and approval by the Board of Directors before publication | Any power to approve or certify devices, to give its recommendations legal force, or to make clinical decisions for individuals |
| Relation to regulation | The guideline is updated when regulatory changes or device approvals warrant it. Recommendation 7.12 recommends meters approved by the FDA (or a comparable regulator elsewhere) | The power to set approval criteria, the outcome of an FDA review such as a 510(k), or the setting of meter accuracy standards |
| Geography | A US-based organisation whose guideline mainly addresses US clinical practice. Recommendation 7.12 also refers to "comparable regulatory agencies for other geographical locations" | The regulations and clinical guidelines of the EU or Japan. We could not confirm how the ADA guideline is treated outside the United States |
| Funding and independence | The Standards of Care are funded from ADA general revenue, with no financial support from industry. Committee members are unpaid and must disclose dualities of interest | The ADA as a whole accepts corporate support (its website has a corporate support page); this is separate from the cost of producing the guideline |
| Insurance and reimbursement | Recommendation 7.5 recommends continued access to devices through third-party payors for people using CGM, pumps or AID | The power to decide reimbursement. We could not confirm how payors use the guideline |
| Scale | Over 10,000 health care professionals, over 400 staff and a volunteer network of over 565,000. More than 12,000 attend the annual meeting | - |
5. How the guideline is made and used
The Standards of Care are produced through systematic literature searches and deliberation by an expert committee. Device approvals and regulatory changes are named as reasons for revising the guideline, which shows a division of roles: regulators decide approval, and the ADA sets out clinical positioning.
| Organisation | Relationship with the ADA (as stated in primary sources) |
|---|---|
| FDA | Section 7 recommends meters approved by the FDA (or a comparable regulator elsewhere), cites FDA guidance as the source of the figures in Table 7.1, and states that most CGM systems are designated iCGM and cleared as class II medical devices by the FDA |
| ISO | The guideline says the two most used standards for meter accuracy are ISO 15197:2013 and the FDA's (see our ISO profile) |
| Diabetes Technology Society (DTS) | The ADA and the DTS co-host the 26th Diabetes Technology Meeting, 27 to 29 October 2026, in Washington, DC |
Table 7.3 of the guideline lists brand names as definitions of the types of CGM now available, among them products of Abbott (the FreeStyle Libre family and Lingo) and Dexcom (G6, G7 and Stelo), as well as Eversense, Guardian and Simplera Sourced. The ADA presents the table to explain the types; it does not compare or recommend products. Where our company profiles in this series (in preparation) cover those makers' products, the ADA's wording is a reference for clinical classification, not an assessment of the companies. The differences between regulatory pathways are covered in our explainer on medical device approval categories and home use, and continuous glucose monitoring in our explainer of that name.
6. Outlook
| What we can read | Primary information behind it | Type |
|---|---|---|
| The guideline is revised every year and updated online at any time when device approvals or regulatory changes warrant it | The "Introduction and Methodology" of the 2026 edition and the ADA's Standards of Care page | Sourced |
| The next major venues are the 26th Diabetes Technology Meeting (27 to 29 October 2026) and the 2027 Scientific Sessions (18 to 21 June 2027; abstracts due by 5 January 2027) | The ADA's pages for the meeting and for the Scientific Sessions | Sourced |
| Which device types and recommendations will be added in the 2027 edition | As of October 2026 the content of the 2027 edition has not been published | Not yet confirmed |
| As new device types are approved, they are likely to be reflected in turn in the guideline's device tables (such as Table 7.3) | The guideline says it is updated for regulatory changes and device approvals, and the 2026 Table 7.3 already includes the over-the-counter CGM (OTC-CGM) type | Inference |
7. Glossary
- Standards of Care in Diabetes
- The ADA's clinical guideline. It collects the ADA's current clinical practice recommendations and is revised every year, for clinicians to apply to each person.
- Professional Practice Committee (PPC)
- The expert committee that updates the Standards of Care each year.
- Evidence grade
- A letter showing the strength of evidence behind a recommendation: A (clear evidence, such as adequately powered randomised controlled trials), B (supportive evidence, such as trials with a flaw or well-conducted cohort studies), C (supportive evidence from poorly controlled or uncontrolled studies) and E (expert consensus or clinical experience).
- BGM
- Blood glucose monitoring: measuring glucose in a blood sample, such as from a fingertip, with a meter.
- CGM
- Continuous glucose monitoring: continuous measurement of glucose in the interstitial fluid under the skin. Types include real-time CGM (rtCGM) and over-the-counter CGM (OTC-CGM).
- iCGM
- Integrated CGM: a CGM that the FDA has cleared as a class II medical device for use with other digitally connected devices.
- AID
- Automated insulin delivery: a system in which an algorithm adjusts insulin delivery on the basis of CGM readings.
8. References
- American Diabetes Association Who We Are (over 565,000 volunteers, over 10,000 health care professionals, over 400 staff, corporate support page). https://diabetes.org/about-us
- ADA Press release "The American Diabetes Association Marks 85 Years" (5 August 2025: founded 1940, yearly Standards of Care since 1989, voluntary health organization, Arlington, VA). https://diabetes.org/newsroom/press-releases/american-diabetes-association-marks-85-years-advancements-diabetes-care-and
- ADA Standards of Care in Diabetes (the Standards of Care page: purpose, annual updates and updates online at any time, list of sections). https://professional.diabetes.org/standards-of-care
- ADA Professional Practice Committee for Diabetes Introduction and Methodology: Standards of Care in Diabetes-2026 (Diabetes Care 2026;49(Suppl. 1):S1-S5, DOI 10.2337/dc26-SINT: funding source, unpaid members, disclosure of interests, period of the literature search, peer review and Board approval, evidence grades). Open PubMed Central version. https://pmc.ncbi.nlm.nih.gov/articles/PMC12690168/
- ADA Professional Practice Committee for Diabetes 7. Diabetes Technology: Standards of Care in Diabetes-2026 (Diabetes Care 2026;49(Suppl. 1):S150-S165, DOI 10.2337/dc26-S007: Recommendations 7.1 to 7.30, Tables 7.1 to 7.3). Open PubMed Central version. https://pmc.ncbi.nlm.nih.gov/articles/PMC12690173/
- ADA Professional Practice Committee for Diabetes Summary of Revisions: Standards of Care in Diabetes-2026 (changes to Sections 6 and 7). Open PubMed Central version. https://pmc.ncbi.nlm.nih.gov/articles/PMC12690167/
- Crossref Bibliographic record for DOI 10.2337/dc26-s007 (Diabetes Care vol. 49, supplement 1, pp. S150-S165, published 8 December 2025). https://api.crossref.org/works/10.2337/dc26-s007
- ADA Diabetes Technology (scope of diabetes technology and the guideline chapter). https://professional.diabetes.org/diabetes-technology
- ADA Scientific Sessions (2027: 18 to 21 June, Washington, DC; over 12,000 attendees a year; abstracts accepted until 5 January 2027). https://professional.diabetes.org/scientific-sessions
- ADA Diabetes Technology Meeting (26th meeting, co-hosted with the DTS, 27 to 29 October 2026). https://professional.diabetes.org/meetings/diabetes-technology-meeting
9. Claim-to-source audit
| Claim in the text | Type | Source |
|---|---|---|
| Over 565,000 volunteers, over 10,000 health care professionals, over 400 staff; the website has a corporate support page | Sourced | Reference 1 https://diabetes.org/about-us |
| Founded 1940; the Standards of Care published yearly since 1989; voluntary health organization; Arlington, Virginia | Sourced | Reference 2 https://diabetes.org/newsroom/press-releases/american-diabetes-association-marks-85-years-advancements-diabetes-care-and |
| Purpose of the Standards of Care; annual updates and updates online at any time; list of sections | Sourced | Reference 3 https://professional.diabetes.org/standards-of-care |
| Funding from ADA general revenue with no industry funding; unpaid members; disclosure of interests; period of the literature search; peer review and Board approval; evidence grades; recommendations to be applied to each person | Sourced | Reference 4 https://pmc.ncbi.nlm.nih.gov/articles/PMC12690168/ |
| Recommendations 7.3a, 7.3b, 7.5, 7.12, 7.15, 7.19 and 7.20; Tables 7.1 to 7.3 (accuracy standards, interfering substances, CGM types); iCGM cleared as class II; mention of ISO 15197:2013 and the FDA's criteria | Sourced | Reference 5 https://pmc.ncbi.nlm.nih.gov/articles/PMC12690173/ |
| 2026 changes: individualised CGM-metric goals in Section 6; education and training recommendations in Section 7, the split of 7.3, and 7.6 and 7.7 | Sourced | Reference 6 https://pmc.ncbi.nlm.nih.gov/articles/PMC12690167/ |
| Section 7 in Diabetes Care vol. 49, supplement 1, pp. S150-S165, published online 8 December 2025 | Sourced | Reference 7 https://api.crossref.org/works/10.2337/dc26-s007 Reference 5 https://pmc.ncbi.nlm.nih.gov/articles/PMC12690173/ |
| Scope of diabetes technology and the guideline chapter | Sourced | Reference 8 https://professional.diabetes.org/diabetes-technology |
| Scientific Sessions: 18 to 21 June 2027, over 12,000 attendees a year, abstracts until 5 January 2027 | Sourced | Reference 9 https://professional.diabetes.org/scientific-sessions |
| 26th Diabetes Technology Meeting, co-hosted with the DTS, 27 to 29 October 2026 | Sourced | Reference 10 https://professional.diabetes.org/meetings/diabetes-technology-meeting |
| The four-type classification, the summary of the flow in Fig. 2, and the materials engineer's reading | Our calculation | Our own grouping, based on References 4 and 5 |
| Content of the 2027 edition, how payors use the guideline, and the standing of the ADA guideline in the EU and Japan | Not yet confirmed | Not found in official materials as of October 2026. This article does not estimate them |
| New device types are likely to be reflected in turn in the guideline's device tables | Inference | Our reading of the update policy (References 3 and 4) and of Table 7.3 including OTC-CGM (Reference 5); this article's interpretation |
Last updated 4 October 2026 / Troy Technical
This article summarises an organisation and its guideline from the ADA's official materials. It is not advice on diagnosis, treatment or the reading of any individual's measurements. Items marked "Inference" are this article's reading of the primary information.