From the Guidelines
For a patient with an A1c greater than 16%, immediate intensive intervention is necessary, and I recommend starting with insulin therapy, typically a basal-bolus regimen, as outlined in the 2016 American Diabetes Association standards of medical care in diabetes 1. This approach is supported by the most recent and highest quality studies, which emphasize the importance of timely and aggressive management of severe hyperglycemia to prevent acute and chronic complications. The basal-bolus regimen should consist of a long-acting insulin, such as insulin glargine, at a dose of 0.3-0.5 units/kg/day, plus rapid-acting insulin, such as insulin lispro, aspart, or glulisine, before meals at 0.1-0.2 units/kg per meal. Concurrent initiation of metformin is also recommended, if not contraindicated, starting at 500mg daily and titrating up to 1000mg twice daily as tolerated. Close glucose monitoring is essential, with fingerstick checks 4 times daily (before meals and at bedtime), and the patient should be evaluated weekly initially for insulin dose adjustments until glucose levels stabilize. Hydration status must be assessed immediately, as severe hyperglycemia can lead to hyperosmolar states or diabetic ketoacidosis, and education on hypoglycemia recognition and management is crucial. It's worth noting that the 2021 standards of medical care in diabetes also emphasize the importance of individualized care, particularly in older adults or those with advanced disease, where the focus may shift from tight glycemic control to prevention of hypoglycemia and management of hyperglycemia 1. However, for a patient with an A1c greater than 16%, the primary goal is to rapidly improve glycemic control and prevent acute complications, making the basal-bolus insulin regimen the most appropriate initial approach. As glucose levels improve, additional oral agents or GLP-1 receptor agonists may be considered based on the patient's specific characteristics. Key points to consider in the management of a patient with an A1c greater than 16% include:
- Immediate initiation of insulin therapy, typically a basal-bolus regimen
- Concurrent use of metformin, if not contraindicated
- Close glucose monitoring and frequent insulin dose adjustments
- Assessment and management of hydration status
- Education on hypoglycemia recognition and management
- Individualized care, taking into account the patient's specific characteristics and comorbidities.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Diabetes Management for A1c > 16
Overview of Treatment Options
- The American Association of Clinical Endocrinologists and the American Diabetes Association recommend considering insulin administration for people with type 2 diabetes with HbA1c levels exceeding 9.0% and 10%, respectively 2.
- However, other treatment options such as metformin, incretin-based treatments, SGLT2 inhibitors, and thiazolidinediones can also be effective in reducing HbA1c levels 2, 3, 4, 5, 6.
Comparison of Treatment Options
- A study comparing exenatide QW and liraglutide with insulin glargine found that the GLP-1RA led to greater reductions in HbA1c than insulin glargine, particularly in patients with higher baseline HbA1c levels 2.
- Another study found that the combination of metformin and a DPP-4 inhibitor with or without a sulfonylurea was effective in reducing HbA1c levels, with 31.7% of patients achieving a target HbA1c level of ≤7.0% 3.
- A meta-analysis comparing SGLT2 inhibitors with sulfonylureas as add-on therapy to metformin found that SGLT2 inhibitors led to similar reductions in HbA1c, but with less hypoglycemia and greater weight loss 5.
- A systematic review comparing SGLT2 inhibitors with DPP-4 inhibitors as add-ons to metformin found that SGLT2 inhibitors led to slightly greater reductions in HbA1c, particularly in patients with lower baseline HbA1c levels 6.
Considerations for Treatment Selection
- The choice of treatment should be based on individual patient factors, including baseline HbA1c level, presence of symptoms, and other health conditions 2, 3, 4, 5, 6.
- Consideration should also be given to the potential benefits and risks of each treatment option, including the risk of hypoglycemia, weight gain, and other adverse events 2, 3, 4, 5, 6.