Assessment of Glycemic Control
2021 vs 2022: TIR/GMI 的概念 不只是評估 -> 管理血糖/低血糖/自我效能
血糖控制通過 A1C 測量、連續血糖監測 (CGM) 使用範圍內時間 (TIR) 和/或血糖管理指標 (GMI) (2022增）和血糖自我監測 (SMBG) 來評估。 A1C 是迄今為止在臨床試驗中使用的指標，用於證明改善血糖控制的益處。 患者 SMBG 可用於自我管理和藥物調整，特別是在服用胰島素的個體中。 CGM 在評估 管理 許多 1 型糖尿病患者（包括預防低血糖）和某些 2 型糖尿病患者（例如接受強化胰島素治療方案的患者和接受與 低血糖。使用多種胰島素方案的個體可以從 CGM 中受益，改善血糖控制、減少低血糖和增強自我效能 (2022增)
glycemic control is assessed by the A1C measurement, continuous glucose monitoring (CGM), using either time in range (TIR) and/or glucose management indicator (GMI) (2022增）, and self-monitoring of blood glucose (SMBG). A1C is the metric used to date in clinical trials demonstrating the benefits of improved glycemic control. Patient SMBG can be used with self-management and medication adjustment, particularly in individuals taking insulin. CGM serves an increasingly important role in assessingthe management of the effectiveness and safety of treatment in many patients with type 1 diabetes, including prevention of hypoglycemia, (2022 刪）and in selected patients with type 2 diabetes, such as in those on intensive insulin regimens and in those on regimens associated with hypoglycemia. Individuals on a variety of insulin regimens can benefit from CGM with improved glucose control, decreased hypoglycemia, and enhanced self-efficacy (2022增）
Glycemic Assessment
2021 vs 2022：
A1C 反映了大約 3 個月的平均血糖。對於經NGSP 認證的檢測，該測試的性能通常非常出色。該測試是評估血糖控制的主要工具，對糖尿病並發症具有很強的預測價值 (2-4)。因此，所有糖尿病患者在初始評估時都應常規進行 A1C 檢測，並將其作為持續治療的一部分。大約每 3 個月進行一次測量可確定患者的血糖目標是否已達到和維持。 TIR 和 GMI 的 14 天 CGM 評估可作為 A1C 的替代指標用於臨床管理 (5,7,9)(2022增）。 A1C 檢測的頻率應取決於臨床情況、治療方案和臨床醫生的判斷。使用即時 A1C 測試或 CGM 衍生的 TIR 和 GMI 可能為在患者和提供者之間的相遇期間更及時地改變治療提供機會。血糖穩定在目標範圍內的 2 型糖尿病患者可能每年只進行兩次 A1C 檢測或其他血糖評估。不穩定或集中管理的患者或未達到治療調整目標的人可能需要更頻繁地進行測試（每 3 個月進行一次中期評估，以確保安全性）（10）。可以在診所或通過遠程醫療跟踪 CGM 參數以優化糖尿病管理。(2022增）
A1C reflects average glycemia over approximately 3 months. The performance of the test is generally excellent for National Glycohemoglobin Standardization Program (NGSP)-certified assays (see www.ngsp.org). The test is the primary tool for assessing glycemic control and has a strong predictive value for diabetes complications (2–4). Thus, A1C testing should be performed routinely in all patients with diabetes at initial assessment and as part of continuing care. Measurement approximately every 3 months determines whether patients’ glycemic targets have been reached and maintained. A 14-day CGM assessment of TIR and GMI can serve as a surrogate for A1C for use in clinical management (5–9). The frequency of A1C testing should depend on the clinical situation, the treatment regimen, and the clinician’s judgment. The use of point-of-care A1C testing or CGM-derived TIR and GMI may provide an opportunity for more timely treatment changes during encounters between patients and providers. People with type 2 diabetes with stable glycemia well within target may do well with A1C testing or other glucose assessment only twice per year. Unstable or intensively managed patients or people not at goal with treatment adjustments may require testing more frequently (every 3 months with interim assessments as needed for safety) (10). CGM parameters can be tracked in the clinic or via telemedicine to optimize diabetes management.
2021 vs 2022:
A1C 不提供血糖變異性或低血糖的測量。 對於容易出現血糖波動的患者，尤其是患有嚴重胰島素缺乏的 1 型糖尿病或 2 型糖尿病患者，最好通過 SMBG (BGM) 或 CGM 和 A1C 的結果來評估血糖控制。A1C 還可以告知患者 CGM 或儀表（或患者報告的 SMBG 結果）的準確性以及 SMBG 監測的充分性。BGM/CGM 和 A1C 之間的不一致結果可能是上述條件或血糖變異性的結果，BGM 缺少極端情況。 （2022年修）
A1C does not provide a measure of glycemic variability or hypoglycemia. For patients prone to glycemic variability, especially patients with type 1 diabetes or type 2 diabetes with severe insulin deficiency, glycemic control is best evaluated by the combination of results from SMBG (BGM) or CGM and A1C.
Discordant results between BGM/CGM and A1C can be the result of the conditions outlined above or glycemic variability, with BGM missing the extremes. (2022修）
A1C Differences in Ethnic Populations and Children
2021 vs 2022
在 ADAG 研究中，在 A1C 和平均血糖之間的回歸線中，種族和族裔群體之間沒有顯著差異，儘管該研究不足以檢測到差異，並且非洲裔和非裔美國人之間存在差異的趨勢，以及 非西班牙裔白人隊列，在給定的平均葡萄糖下，與非西班牙裔白人相比，在非洲人和非裔美國人中觀察到的 A1C 值更高。 其他研究也表明，在給定的平均葡萄糖濃度下，非裔美國人的 A1C 水平高於白人 (14,15)。 相比之下，非洲裔加勒比地區最近的一份報告發現 A1C 相對於葡萄糖值較低 (16)。 總之，A1C 和葡萄糖參數對於最佳評估血糖狀態至關重要。2022年增）
In the ADAG study, there were no significant differences among racial and ethnic groups in the regression lines between A1C and mean glucose, although the study was underpowered to detect a difference and there was a trend toward a difference between the African and African American and the non-Hispanic White cohorts, with higher A1C values observed in Africans and African Americans compared with non-Hispanic Whites for a given mean glucose. Other studies have also demonstrated higher A1C levels in African Americans than in Whites at a given mean glucose concentration (14,15). In contrast, a recent report in Afro-Caribbeans found lower A1C relative to glucose values (16). Taken together, A1C and glucose parameters are essential for the optimal assessment of glycemic status. 2022年增）
Glucose Assessment by Continuous Glucose Monitoring Recommendations
2021 vs 2022:
6.4 範圍內時間 (TIR) 與微血管並發症的風險相關，應該是向前推進的臨床試驗可接受的終點，（2022 刪）並可用於評估血糖控制。 此外，低於目標的時間和高於目標的時間是重新評估治療方案的有用參數。 C
6.4 Time in range (TIR) is associated with the risk of microvascular complications, should be an acceptable end point for clinical trials moving forward, (2022刪) and can be used for assessment of glycemic control. Additionally, time below target (<70 and <54 mg/dL ) and time above target (>180 mg/dL) are useful parameters for reevaluation of the treatment regimen. C
2021 vs 2022: CGM in T1DM： 標準的血糖監監，not附加或補充方法
對於許多醣尿病患者來說，血糖監測是實現血糖目標的關鍵。 胰島素治療患者的主要臨床試驗已將 SMBG 作為多因素干預的一部分，以證明強化血糖控制對糖尿病並發症的益處 (25)。 因此，SMBG 是對服用胰島素的患者進行有效治療的一個組成部分。 近年來，CGM 已成為評估血糖水平的補充方法 大多數 1 型糖尿病成人血糖監測的標準方法。
For many people with diabetes, glucose monitoring is key for achieving glycemic targets. Major clinical trials of insulin-treated patients have included SMBG as part of multifactorial interventions to demonstrate the benefit of intensive glycemic control on diabetes complications (25). SMBG is thus an integral component of effective therapy of patients taking insulin. In recent years, CGM has emergedis now a standard as a complementary method for assessing glucose levels.glucose monitoring for most adults with type 1 diabetes
2021 vs 2022: focus TIR and GMI 來作用血糖管理計劃
兩種血糖監測方法都允許患者評估個體對治療的反應並評估是否安全地達到血糖目標。 TIR 國際共識為標準化 CGM 指標（見表 6.2）和臨床解釋和護理考慮提供了指導 (26)。為了使這些指標更具可操作性，建議使用具有視覺提示的標準化報告，例如動態血糖曲線（見圖 6.1）（26），並可能幫助患者和提供者更好地解釋數據以指導治療決策（16， 19）。 SMBG 和 CGM 可用於指導醫學營養治療和身體活動、預防低血糖和輔助藥物管理。雖然 A1C 目前是指導血糖管理的主要指標，也是發展糖尿病並發症的重要風險標誌物，但血糖管理指標 (GMI) 以及其他 CGM 指標提供了更加個性化的糖尿病管理計劃。但 CGM 指標 TIR（時間低於範圍和時間高於範圍）和 GMI 為更個性化的糖尿病管理計劃提供了見解。將這些指標納入臨床實踐正在發展中，遠程訪問這些數據對於遠程醫療至關重要. CGM 術語的優化和協調將不斷發展，以滿足患者和提供者的需求。患者的具體需求和目標應決定 SMBG 的頻率和時間以及 CGM 使用的考慮。
Both approaches to glucose monitoring allow patients to evaluate individual response to therapy and assess whether glycemic targets are being safely achieved. The international consensus on TIR provides guidance on standardized CGM metrics (see Table 6.2) and considerations for clinical interpretation and care (26). To make these metrics more actionable, standardized reports with visual cues, such as the ambulatory glucose profile (see Fig. 6.1), are recommended (26) and may help the patient and the provider better interpret the data to guide treatment decisions (16,19). SMBG and CGM can be useful to guide medical nutrition therapy and physical activity, prevent hypoglycemia, and aid medication management. While A1C is currently the primary measure to guide glucose management and a valuable risk marker for developing diabetes complications, the glucose management indicator (GMI) along with the other CGM metrics provideCGM metrics TIR (with time below range and time above range) and GMI provide the insights for a more personalized diabetes management plan. The incorporation of these metrics into clinical practice is in evolution and remote access to these data can be critical for telemedicine, (2022增）A rapid optimization and harmonization of CGM terminology and remote access is occurring to meet will evolve to suit patient and provider needs. The patient’s specific needs and goals should dictate SMBG frequency and timing and consideration of CGM use.
2021 vs 2022: TIR and GMI 二種都要計算
隨著新技術的出現，CGM 在準確性和可負擔性方面發展迅速。 因此，許多患者擁有這些數據可用於幫助提供者進行自我管理和評估及其提供者對血糖狀態的評估。。 可以從 CGM 生成報告，使提供者能夠確定 TIR , 計算 GMI 並評估低血糖、高血糖和血糖變異性。 正如最近的共識文件中所討論的，可以生成格式如圖 6.1 所示的報告 (26)。 已發表的數據表明 TIR 和 A1C 之間存在很強的相關性，在兩項前瞻性研究中，目標是 70% 的 TIR 與約 7% 的 A1C 一致 (18,27)。請注意圖 6.1 中每個指標旁邊的治療目標（例如，低，<4%；非常低，<1%）作為指導治療變化的值。
With the advent of new technology, CGM has evolved rapidly in both accuracy and affordability. As such, many patients have these data available to assist with both self-management and assessment by providers their providers’ assessment of glycemic status. Reports can be generated from CGM that will allow the provider to determine TIR and toand person with diabetes to determine TIR, calculate GMI, and assess hypoglycemia, hyperglycemia, and glycemic variability. As discussed in a recent consensus document, a report formatted as shown in Fig. 6.1 can be generated (26). Published data suggest a strong correlation between TIR and A1C, with a goal of 70% TIR aligning with an A1C of ∼7% in two prospective studies (18,27). Note the goals of therapy next to each metric in Fig. 6.1 (e.g., low, <4%; very low, <1%) as values to guide changes in therapy.
Glycemic Goals
2021 vs 2022:
6.5b 如果使用動態血糖譜/血糖管理指標來評估血糖，許多非妊娠成人的平行目標是 TIR >70% ，TBR <4%，Time <54 mg/dL <1% (2022 新增）
6.5b If using ambulatory glucose profile/glucose management indicator to assess glycemia, a parallel goal for many nonpregnant adults is a time in range of >70% with time below range <4% and time <54 mg/dL <1% (Fig. 6.1 and Table 6.2). B
Setting and Modifying A1C Goals
2021 vs 2022:
圖 6.2 描述了個性化目標時要考慮的因素。 該數字並非旨在嚴格應用，而是用作指導臨床決策的廣泛結構 (68) 並使 1 型和 2 型糖尿病患者參與共同決策。 如果可以安全地達到目標，並且治療負擔可以接受，並且預期壽命足以獲得嚴格目標的益處，則可以推薦 更嚴格 更積極的目標
The factors to consider in individualizing goals are depicted in Fig. 6.2. This figure is not designed to be applied rigidly but to be used as a broad construct to guide clinical decision-making (59) and engage in shared decision-making in people with type 1 and type 2 diabetes. More stringentaggressive targets may be recommended if they can be achieved safely and with acceptable burden of therapy and if life expectancy is sufficient to reap benefits of stringent targets.
2021 vs 2022: 血糖變異度-> 增加低血糖 esp 3級->死亡率增加
依賴住院、急診科就診和救護車索賠數據的 3 級低血糖發生率研究大大低估了 3 級低血糖的發生率 (89)，但揭示了社區中 60 歲以上成年人的低血糖負擔很高。 90)。非裔美國人患 3 級低血糖的風險顯著增加 (90,91)。除年齡和種族外，在以社區為基礎的 2 型糖尿病老年黑人和白人成人流行病學隊列中發現的其他重要風險因素包括胰島素使用、血糖控制不佳或中度與良好、白蛋白尿和認知功能差 (90) .在 ACCORD 試驗的標準和強化血糖組中，3 級低血糖與參與者的死亡率相關，但低血糖、達到的 A1C 和治療強度之間的關係並不直接。在 ADVANCE 試驗中也發現了 3 級低血糖與死亡率之間的關聯（92）。臨床實踐中也報導了自我報告的 3 級低血糖與 5 年死亡率之間的關聯（93）。葡萄糖變異性也與低血糖風險增加有關 (94)。
Studies of rates of level 3 hypoglycemia that rely on claims data for hospitalization, emergency department visits, and ambulance use substantially underestimate rates of level 3 hypoglycemia (89) yet reveal a high burden of hypoglycemia in adults over 60 years of age in the community (90). African Americans are at substantially increased risk of level 3 hypoglycemia (90,91). In addition to age and race, other important risk factors found in a community-based epidemiologic cohort of older Black and White adults with type 2 diabetes include insulin use, poor or moderate versus good glycemic control, albuminuria, and poor cognitive function (90). Level 3 hypoglycemia was associated with mortality in participants in both the standard and the intensive glycemia arms of the ACCORD trial, but the relationships between hypoglycemia, achieved A1C, and treatment intensity were not straightforward. An association of level 3 hypoglycemia with mortality was also found in the ADVANCE trial (92). An association between self-reported level 3 hypoglycemia and 5-year mortality has also been reported in clinical practice (93). Glucose variability is also associated with an increased risk for hypoglycemia (94). (2022增）
2021 vs 2022:
患有 1 型糖尿病的幼兒和老年人，包括 1 型和 2 型糖尿病患者 (86,95)，由於識別低血糖症狀和有效溝通需求的能力降低，因此特別容易患低血糖症。 個體化的血糖目標、患者教育、飲食干預（例如，當特別需要治療低血糖時，睡前點心以防止夜間低血糖）、運動管理、藥物調整、血糖監測和常規臨床監測可能會改善患者的預後（96）。 具有自動低葡萄糖暫停和混合閉環系統的 CGM 已被證明可有效減少 1 型糖尿病的低血糖症 (97)。 對於 3 級低血糖和儘管接受藥物治療仍持續存在低血糖無意識的 1 型糖尿病患者，人類胰島移植可能是一種選擇，但該方法仍處於試驗階段 (98,99)。
Young children with type 1 diabetes and the elderly, including those with type 1 and type 2 diabetes (86,95), are noted as particularly vulnerable to hypoglycemia because of their reduced ability to recognize hypoglycemic symptoms and effectively communicate their needs. Individualized glucose targets, patient education, dietary intervention (e.g., bedtime snack to prevent overnight hypoglycemia when specifically needed to treat low blood glucose), exercise management, medication adjustment, glucose monitoring, and routine clinical surveillance may improve patient outcomes (96). CGM with automated low glucose suspend and hybrid closed-loop systems (2022增 have been shown to be effective in reducing hypoglycemia in type 1 diabetes (97). For patients with type 1 diabetes with level 3 hypoglycemia and hypoglycemia unawareness that persists despite medical treatment, human islet transplantation may be an option, but the approach remains experimental (98,99).
2021 vs 2022 新增eady-to-inject glucagon preparations glucagon
Glucagon用於治療不能或不願口服碳水化合物的人的低血糖症。應指導與易患低血糖症的糖尿病患者（家庭成員、室友、學校工作人員、托兒服務提供者、懲教機構工作人員或同事）密切接觸或接受監護的人使用胰高血糖素，包括Glucagon在哪裡產品被保存以及何時以及如何管理它。個人不需要是醫療保健專業人員即可安全地管理胰高血糖素。除了需要在註射前重組的傳統Glucagon注射粉外，還有用於皮下注射的鼻內Glucagon和Glucagon溶液。應注意確保胰高血糖素產品不會過期。胰高血糖素用於治療不能或不願口服碳水化合物的人的低血糖症。應指導與易患低血糖症的糖尿病患者（家庭成員、室友、學校工作人員、托兒服務提供者、懲教機構工作人員或同事）密切接觸或接受監護的人使用胰高血糖素，包括胰高血糖素在哪裡產品被保存以及何時以及如何管理它。個人不需要是醫療保健專業人員即可安全地管理胰高血糖素。除了需要在註射前重組的傳統Glucagon注射粉外，還有用於皮下注射的鼻內Glucagon和即用型Glucagon製劑 (2022增)。應注意確保Glucagon產品不會過期。
Glucagon
The use of glucagon is indicated for the treatment of hypoglycemia in people unable or unwilling to consume carbohydrates by mouth. Those in close contact with, or having custodial care of, people with hypoglycemia-prone diabetes (family members, roommates, school personnel, childcare providers, correctional institution staff, or coworkers) should be instructed on the use of glucagon, including where the glucagon product is kept and when and how to administer it. An individual does not need to be a health care professional to safely administer glucagon. In addition to traditional glucagon injection powder that requires reconstitution prior to injection, intranasal glucagon and glucagon solution for subcutaneous injection are available. Care should be taken to ensure that glucagon products are not expired. The use of glucagon is indicated for the treatment of hypoglycemia in people unable or unwilling to consume carbohydrates by mouth. Those in close contact with, or having custodial care of, people with hypoglycemia-prone diabetes (family members, roommates, school personnel, childcare providers, correctional institution staff, or coworkers) should be instructed on the use of glucagon, including where the glucagon product is kept and when and how to administer it. An individual does not need to be a health care professional to safely administer glucagon. In addition to traditional glucagon injection powder that requires reconstitution prior to injection, intranasal glucagon and ready-to-inject glucagon preparations for subcutaneous injection are available. Care should be taken to ensure that glucagon products are not expired.
2021 vs 2022: 需急迫的策略來避免低血糖
低血糖預防
低血糖預防是糖尿病管理的重要組成部分。 SMBG 和對某些患者而言，CGM 是評估治療和檢測早期低血糖的重要工具。患者應該了解會增加低血糖風險的情況，例如在進行檢查或手術時禁食、進餐延遲、飲酒期間和之後、劇烈運動期間和之後以及睡眠期間。低血糖可能會增加傷害自己或他人的風險，例如駕駛。教導糖尿病患者平衡胰島素使用、碳水化合物攝入和運動是必要的，但這些策略並不總是足以預防。低血糖預防是糖尿病管理的重要組成部分。 BGM，對於某些患者，CGM 是評估治療和檢測早期低血糖的重要工具。患者應了解會增加低血糖風險的情況，例如在進行實驗室檢查或手術時禁食、進餐延遲、飲酒期間和之後、劇烈運動期間和之後以及睡眠期間。低血糖可能會增加對自己或他人造成傷害的風險，例如在駕駛時。教導糖尿病患者平衡胰島素使用、碳水化合物攝入和運動是必要的，但這些策略並不總是足以預防 (82,104–106)。已經制定了提高低血糖意識和製定減少低血糖策略的正式培訓計劃，包括血糖意識培訓計劃、正常飲食調整劑量 (DAFNE) 和 DAFNEplus。相反，一些害怕高血糖的有低血糖的第 1 型糖尿病患者，不敢放鬆血糖目標 (78,80)。不管導致低血糖和低血糖無意識的因素如何，這代表了一個需要干預的緊迫醫學問題。(2022增)
Hypoglycemia Prevention
Hypoglycemia prevention is a critical component of diabetes management. SMBG and, for some patients, CGM are essential tools to assess therapy and detect incipient hypoglycemia. Patients should understand situations that increase their risk of hypoglycemia, such as when fasting for tests or procedures, when meals are delayed, during and after the consumption of alcohol, during and after intense exercise, and during sleep. Hypoglycemia may increase the risk of harm to self or others, such as with driving. Teaching people with diabetes to balance insulin use and carbohydrate intake and exercise are necessary, but these strategies are not always sufficient for prevention. Hypoglycemia prevention is a critical component of diabetes management. BGM and, for some patients, CGM are essential tools to assess therapy and detect incipient hypoglycemia. Patients should understand situations that increase their risk of hypoglycemia, such as when fasting for laboratory tests or procedures, when meals are delayed, during and after the consumption of alcohol, during and after intense exercise, and during sleep. Hypoglycemia may increase the risk of harm to self or others, such as when driving. Teaching people with diabetes to balance insulin use and carbohydrate intake and exercise are necessary, but these strategies are not always sufficient for prevention (82,104–106). Formal training programs to increase awareness of hypoglycemia and to develop strategies to decrease hypoglycemia have been developed, including the Blood Glucose Awareness Training Programme, Dose Adjusted for Normal Eating (DAFNE), and DAFNEplus. Conversely, some individuals with type 1 diabetes and hypoglycemia who have a fear of hyperglycemia are resistant to relaxation of glycemic targets (78,80). Regardless of the factors contributing to hypoglycemia and hypoglycemia unawareness, this represents an urgent medical issue requiring intervention.
在 1 型糖尿病和嚴重缺乏胰島素的 2 型糖尿病中，低血糖無意識（或低血糖相關的自主神經衰竭）會嚴重影響嚴格的糖尿病控制和生活質量。 這種綜合徵的特點是反調節激素釋放不足，尤其是在老年人中，以及自主神經反應減弱，這些都是低血糖的危險因素和引起的。 這種“惡性循環”的一個必然結果是，已證明數週避免低血糖可改善許多患者的反調節和低血糖意識 (107)。 因此，患有一次或多次臨床顯著低血糖發作的患者可能會受益於至少短期的血糖目標放鬆和胰高血糖素的可用性（108）。 任何反復出現低血糖或無意識低血糖的人都應調整其血糖管理方案
In type 1 diabetes and severely insulin-deficient type 2 diabetes, hypoglycemia unawareness (or hypoglycemia-associated autonomic failure) can severely compromise stringent diabetes control and quality of life. This syndrome is characterized by deficient counterregulatory hormone release, especially in older adults, and a diminished autonomic response, which are both risk factors for and caused by hypoglycemia. A corollary to this “vicious cycle” is that several weeks of avoidance of hypoglycemia has been demonstrated to improve counterregulation and hypoglycemia awareness in many patients (107). Hence, patients with one or more episodes of clinically significant hypoglycemia may benefit from at least short-term relaxation of glycemic targets and availability of glucagon (108). Any person with recurrent hypoglycemia or hypoglycemia unawareness should have their glucose management regimen adjusted.2022增)