What is the management of a patient with type 2 diabetes mellitus (T2DM) and severe hyperglycemia, as indicated by a hemoglobin A1c (HbA1c) level of severely impaired glucose control?

From the Guidelines

Management of a type 2 diabetic with an A1c of 15.5 requires immediate initiation of insulin therapy, as recommended by the standards of medical care for type 2 diabetes in China 2019 1.

Key Considerations

• The patient's high A1c level indicates severe hyperglycemia, putting them at risk for complications such as diabetic ketoacidosis, hyperosmolar hyperglycemic state, and long-term microvascular damage.
• Insulin therapy may start with one to two daily injections, and short-term intensive insulin treatment may be implemented for newly diagnosed patients with T2DM with HbA1c > 9.0% or FPG ≥ 11.1 mmol/L and symptomatic hyperglycaemia 1.
• The patient should also be started on metformin 500mg twice daily, gradually increasing to 1000mg twice daily as tolerated, as part of a comprehensive management plan.

Treatment Plan

• Initiate insulin therapy with basal insulin (such as insulin glargine 10 units at bedtime) plus mealtime insulin (such as insulin lispro or aspart 4-6 units before meals), as this approach has been shown to be effective in achieving glycemic control in patients with type 2 diabetes 1.
• Check blood glucose levels 4 times daily (before meals and at bedtime) and follow up within 1-2 weeks for dose adjustments.
• Concurrent management should include:
  • Diabetes education
  • Medical nutrition therapy
  • Addressing cardiovascular risk factors with statin therapy and possibly an SGLT-2 inhibitor or GLP-1 receptor agonist once glucose levels improve, as recommended by the dcrm 2.0: multispecialty practice recommendations for the management of diabetes, cardiorenal, and metabolic diseases 1.

Monitoring and Follow-up

• Hydration status should be assessed immediately, and the patient should be screened for symptoms of hyperglycemic crisis including excessive thirst, frequent urination, blurred vision, fatigue, and abdominal pain.
• Depending on the patient's clinical status, hospitalization may be necessary if they show signs of dehydration, altered mental status, or metabolic decompensation.

From the FDA Drug Label

The results are presented in Table 7 Table 7: Mean Change in Fasting Plasma Glucose and HbA1c at Week 29 Comparing Metformin Hydrochloride Tablets vs Placebo in Patients with Type 2 Diabetes Mellitus *Not statistically significant Metformin Hydrochloride Tablets (n=141) Placebo (n=145) p-Value FPG (mg/dL) Baseline 241.5 237.7 NS * Change at FINAL VISIT –53.0 6.3 0.001 Hemoglobin A1c (%) Baseline 8.4 8.2 NS * Change at FINAL VISIT –1. 4 0.4 0.001

The patient's HbA1c of 15.5 is significantly higher than the baseline values in the study.

• The study does not provide information on managing patients with such a high HbA1c level.
• The study results show that metformin hydrochloride tablets can decrease HbA1c by approximately 1.4% in patients with type 2 diabetes mellitus.
• However, this decrease may not be sufficient to manage a patient with an HbA1c of 15.5.
• No conclusion can be drawn from the study regarding the management of a type 2 diabetic patient with an HbA1c of 15.5 2.

From the Research

Management of Type 2 Diabetes with A1C of 15.5

• The management of type 2 diabetes with an A1C level of 15.5 requires a comprehensive approach, including lifestyle modifications and pharmacological interventions 3, 4, 5, 6.
• Basal insulin analogues, such as glargine and detemir, are commonly used in the management of type 2 diabetes, particularly in patients with high A1C levels 3, 4, 5.
• Studies have shown that both glargine and detemir are effective in improving glycemic control, with similar efficacy and safety profiles 3, 4, 5.
• However, detemir may be associated with less weight gain and hypoglycemia compared to glargine 4, 5.
• The use of basal insulin combined with oral therapy, such as metformin and glimepiride, is also recommended for type 2 diabetes patients who are uncontrolled on oral agents alone 6.
• Continuous glucose monitoring (CGM) has been shown to be effective in improving glucose control and reducing mortality in type 2 diabetes patients, particularly those using insulin 7.
• The initiation of CGM has been associated with lower mortality, all-cause hospitalization, cardiovascular events, and admissions related to hyperglycemia and hypoglycemia in type 2 diabetes patients 7.

Treatment Options

• Basal insulin analogues, such as glargine and detemir, can be considered as treatment options for type 2 diabetes patients with high A1C levels 3, 4, 5.
• The choice of basal insulin analogue should be individualized based on patient factors, such as weight, hypoglycemia risk, and injection preferences 4, 5.
• Oral therapy, such as metformin and glimepiride, can be used in combination with basal insulin to improve glycemic control 6.
• CGM can be considered as an adjunctive therapy to improve glucose control and reduce mortality in type 2 diabetes patients 7.