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Diagnostic Criteria for Diabetes - Let's understand it in light of new and changing criteria.

Introduction.

Diabetes is a chronic condition of "high blood sugar" in our bodies. However, there have been historical changes in the criteria used to determine at what stage the diagnosis of "diabetes" is made. In recent years, diagnostic criteria using not only blood glucose levels but also HbA1c (hemoglobin A1c) have been adopted internationally and reflected in Japanese practice guidelines (e.g., Diabetes Care Guidelines 2024).

This article provides an easy-to-understand explanation of the current diagnostic criteria, their evolution, and points to note. It also introduces the diagnosis and evaluation system at Ikejiri-Ohashi Sera Clinic.

1. current diagnostic criteria - Japanese and international

Japan (Japan Diabetes Society, Clinical Practice Guidelines 2024)

In Japan, the 2024 edition of the guidelines defines diabetes as one of the following

  1. Fasting blood glucose ≥ 126 mg/dL

  2. Blood glucose level ≥ 200 mg/dL after 2 hours of oral glucose tolerance test (OGTT)

  3. HbA1c ≥ 6.5% (but should be used in conjunction with other blood glucose criteria)

  4. Blood glucose at any time (blood glucose measured at any time) ≥ 200 mg/dL + symptoms of hyperglycemia

However, it is stipulated that in cases with typical hyperglycemia symptoms, a single test can be considered definitive. The need for repeat testing depends on the case.

International/U.S. standards (ADA, etc.)

Internationally, the following criteria are commonly used

  • Fasting plasma glucose (FPG) ≥ 126 mg/dL

  • OGTT 2-hour value ≥ 200 mg/dL

  • HbA1c ≥ 6.5 %

  • Blood glucose at any time ≥ 200 mg/dL + hyperglycemic symptoms

These criteria are for the most part consistent with the Japanese standards. However, there are differences among countries and guidelines in whether HbA1c is formally incorporated into the diagnostic criteria and how it is utilized.

2. evolution and recent review of diagnostic criteria

Introduction of HbA1c

In the past, the mainstream criteria for diagnosis were based on blood glucose levels alone, but since 2009, following international discussions, there has been a growing trend to add HbA1c ≥ 6.5% as one of the diagnostic criteria.

With this introduction, it is now possible to reflect average blood glucose, which is less susceptible to temporal blood glucose fluctuations.

Review of normal range of fasting blood glucose

In Japan, there used to be a concept that the upper limit of fasting blood glucose was 110 mg/dL, but this was later revised to set the “normal high” range at 100-109 mg/dL.

Reorganization of Reinspection Requirements

In the past, "two or more positive tests" were often required, but nowadays, the standard is to confirm the results after only one positive test if a high blood glucose level with typical symptoms is confirmed.

Recent adjustments

The latest guidelines emphasize the importance of combining HbA1c with other glycemic criteria. In other words, neither blood glucose nor HbA1c alone is sufficient.

It also states to be aware of factors that can affect HbA1c, such as fluctuations in measurement accuracy, anemia, abnormal renal function, and blood transfusions.

3. points and limitations to note when diagnosing

  • Factors affecting HbA1c: Anemia, impaired renal function, and abnormal red blood cell lifespan can lead to misinterpretation of HbA1c.

  • Environmental dependence of fasting and OGTT testing: dietary restrictive status and test preparation influence the results.

  • Borderline (pre-diabetes) treatment: Fasting blood glucose 100-125 mg/dL and HbA1c 5.7-6.4 % are treated as pre-diabetes (prediabetes) and are considered at high risk for future development.

  • Hyperglycemia without typical symptoms: Many cases test positive without symptoms and are at risk of being missed.

Diagnosis and evaluation system at Ikejiri-Ohashi Sera Clinic

The hospital takes the following actions based on the diagnostic criteria

  1. Combination of multiple measurement methods

      Fasting blood glucose, blood glucose at any time, HbA1c, and if necessary, OGTT are combined for determination.

  2. Timing and determination of re-inspection

      The policy is to make an immediate diagnosis when high blood glucose levels with typical symptoms are confirmed, while asymptomatic cases are retested to confirm the diagnosis.

  3. Complication Risk Assessment

      From the time of diagnosis, a combination of fundus examination, ABI, carotid echocardiography, and Holter electrocardiography are used for early evaluation of vascular, cardiac, and renal effects.

  4. Integration with initial response after diagnosis

      From the time of diagnosis, lifestyle modification, exercise therapy, and nutritional guidance are provided in conjunction. If necessary, a decision is made to begin drug therapy immediately.

  5. Follow-up and Monitoring

      Regularly track blood glucose and HbA1c to check for fluctuations, and begin management with complication prevention in mind immediately after diagnosis.

summary

  • Current diagnostic criteria are determined using fasting blood glucose, OGTT, anytime blood glucose, and HbA1c. If the patient has typical symptoms, the diagnosis can be confirmed at the first time.

  • In the past, there have been transitions such as the non-introduction of HbA1c and the revision of the fasting blood glucose limit, and recently the emphasis has been on "combining multiple criteria.

  • In some cases, HbA1c cannot be determined in isolation because of the factors that influence it.

  • We have a system in place to make precise determinations based on multiple tests, and to evaluate complications and initiate lifestyle improvement at the same time as diagnosis.

References

  1. The Japan Diabetes Society. Guidelines for Diabetes Care 2024.

  2. The Japan Diabetes Society “Guideline for Diagnosis” PDF

  3. Diabetes Standard Medical Practice Manual 2025 (describing diagnostic criteria)

  4. ADA “Diagnosis and Classification of Diabetes.”

  5. New diabetes diagnosis criteria including HbA1c (MHLW data)

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