What is the optimal management plan for a patient with diabetes mellitus (DM) on an insulin pump (Bionics) and continuous glucose monitoring (CGM) (Dexcom) system, with a history of hypoglycemia, hemoglobin A1C (HbA1C) of 7%, and total daily insulin use of 34 units of Novolog (insulin aspart)?

From the Guidelines

The patient should continue using the Bionics insulin pump with Novolog insulin and Dexcom continuous glucose monitoring (CGM), while implementing strategies to improve glycemic control, such as timely carbohydrate entry and setting reminders for pre-meal bolusing, as evidenced by the most recent study on artificial intelligence and machine learning for improving glycemic control in diabetes 1. The patient's current glycemic control shows an A1C of 7% with average blood sugar of 150 mg/dl, and CGM data indicates 70% time in range (TIR), 29% time above range (TAR), and 1% time below range (TBR). The patient is using a total of 34 units of insulin daily, with 14 units as basal, and changes their infusion set every 3 days. They report occasional delays in entering carbohydrate information into their pump. Key considerations for the patient's management include:

• Implementing strategies to improve glycemic control, such as timely carbohydrate entry and setting reminders for pre-meal bolusing, to address the 29% time above range, as suggested by the study on pharmacologic approaches to glycemic treatment 1.
• Maintaining the low rate of hypoglycemia (1% TBR), which is excellent, and ensuring regular follow-up for diabetic retinopathy given their history of eye complications, as recommended by the study on diabetes technology 1.
• Scheduling regular EKG monitoring, as this information is missing from the current assessment, and considering the patient's history of diabetic retinopathy and blindness in the right eye, as noted in the executive summary of standards of medical care in diabetes 1. The patient's current insulin pump therapy with Novolog and CGM has been shown to be effective in improving glycemic control, and with proper management and follow-up, the patient can achieve optimal glycemic control and reduce the risk of complications, as supported by the study on artificial intelligence and machine learning for improving glycemic control in diabetes 1.

From the FDA Drug Label

The rates of reported hypoglycemia depend on the definition of hypoglycemia used, diabetes type, insulin dose, intensity of glucose control, background therapies, and other intrinsic and extrinsic patient factors Severe hypoglycemia was defined as hypoglycemia associated with central nervous system symptoms and requiring the intervention of another person or hospitalization. Adult and pediatric patients with type 1 diabetes mellitus, who received NOVOLOG via continuous subcutaneous insulin infusion by external pump was 2% at 16 weeks and 10% at 16 weeks respectively No severe hypoglycemic episodes were reported in adult patients with type 2 diabetes mellitus receiving NOVOLOG via continuous subcutaneous insulin infusion by external pump at 16 weeks.

The patient's hypoglycemia rate is 1% as per the Time Below Range (TBR) given.

• The severe hypoglycemia rate for adult patients with type 1 diabetes mellitus who received NOVOLOG via continuous subcutaneous insulin infusion by external pump was 2% at 16 weeks 2.
• Since the patient is using an insulin pump and has type 1 diabetes, the risk of severe hypoglycemia should be considered, but the patient's current TBR is 1%, which is lower than the reported rate in the clinical trial.
• It is essential to continue monitoring the patient's blood glucose levels and adjust the insulin regimen as needed to minimize the risk of hypoglycemia.

From the Research

Patient Evaluation

• The patient has been using an insulin pump (Bionics) and Dexcom for diabetes management, with a diabetes onset in 1980 and insulin pump initiation in November.
• The patient's current insulin regimen consists of Novolog via insulin pump, with a total daily insulin use of 34 units and basal insulin of 14 units.
• The patient's A1C level is 7% as of August 2023, and their average blood sugar level is 150 mg/dl, with a time in range (TIR) of 70%, time above range (TAR) of 29%, and time below range (TBR) of 1% 3, 4.

Hypoglycemia Management

• The patient reports experiencing hypoglycemia, which is a critical obstacle to the care of patients with type 1 diabetes 3.
• Sensor-augmented insulin pump therapy with automated insulin suspension has been shown to reduce the incidence of major hypoglycemic events in patients with type 1 diabetes 3.
• The patient's hypoglycemia management may benefit from the use of faster-acting insulin aspart, which has been shown to improve time in range and reduce time above range in adults with type 1 diabetes using a non-automated insulin pump and continuous glucose monitoring 5.

Glycemic Control

• The patient's glycemic control is currently being managed with insulin pump therapy, which has been shown to be effective in reducing glycosylated hemoglobin (HbA1c) levels and severe hypoglycemic events in patients with diabetes 6.
• The patient's TIR of 70% is close to the target of ≥75% suggested by a prospective cohort study of patients with type 1 diabetes using continuous glucose monitoring for three months 4.
• The use of basal insulin degludec has been shown to have similar glycemic control compared to insulin aspart via insulin pump in patients with well-controlled type 1 diabetes 7.