What is the diagnosis and management of Type 1 Diabetes Mellitus (Type 1 DM)?

From the Guidelines

Type 1 diabetes mellitus (T1DM) management should prioritize multiple daily insulin injections or an insulin pump, with a focus on matching prandial insulin to carbohydrate intake, premeal blood glucose, and anticipated activity, as recommended by the most recent guidelines 1.

Key Components of T1DM Management

• Multiple daily insulin injections (3-4 injections per day of basal and prandial insulin) or continuous subcutaneous insulin injection (CSII) therapy
• Matching prandial insulin doses to carbohydrate intake, preprandial blood glucose levels, and anticipated activity level
• Use of insulin analogs to reduce hypoglycemia risk
• Continuous glucose monitoring systems to reduce severe hypoglycemia risk
• Regular medical follow-up every 3-6 months to monitor HbA1c, adjust insulin, and screen for complications

Lifestyle Interventions

• Regular exercise, aiming for at least 150 minutes of moderate-intensity aerobic activity per week
• Maintaining a healthy weight through a balanced diet and regular physical activity
• Limiting alcohol consumption to moderate amounts
• Managing stress levels to minimize impact on blood glucose control

Monitoring and Emergency Preparedness

• Blood glucose monitoring at least 4 times daily or using continuous glucose monitoring
• Carrying emergency glucagon and fast-acting carbohydrates to treat hypoglycemia
• Wearing a medical alert bracelet or necklace to alert others of T1DM diagnosis

Ongoing Education and Support

• Individualized diabetes self-management education and support according to national standards
• Regular assessment of psychosocial and diabetes-related distress, with referrals to trained mental health professionals as needed
• Preconception counseling for all girls of childbearing potential starting at puberty 1

From the FDA Drug Label

In two clinical studies (Studies A and B), adult patients with type 1 diabetes (Study A, n=585, Study B n=534) were randomized to 28 weeks of basal-bolus treatment with Insulin Glargine or NPH insulin. In another clinical study (Study C), patients with type 1 diabetes (n=619) were randomized to 16 weeks of basal-bolus treatment with Insulin Glargine or NPH insulin. In a randomized, controlled clinical study (Study D), pediatric patients (age range 6 to 15 years) with type 1 diabetes (n=349) were treated for 28 weeks with a basal-bolus insulin regimen where regular human insulin was used before each meal.

The treatment of Type 1 Diabetes Mellitus with Insulin Glargine has been studied in several clinical trials, including:

• Adult patients: Studies A, B, and C, which compared the efficacy of Insulin Glargine to NPH insulin in basal-bolus regimens.
• Pediatric patients: Study D, which evaluated the safety and efficacy of Insulin Glargine in a basal-bolus regimen. The results of these studies showed that Insulin Glargine had similar effects on HbA1c and severe symptomatic hypoglycemia compared to NPH insulin 2. Additionally, a study with Insulin Glulisine also evaluated its efficacy in Type 1 Diabetes in adults, showing similar glycemic control compared to Insulin Lispro 3.

From the Research

Type 1 Diabetes Management

• Type 1 diabetes is characterized by insulin deficiency and requires near-physiological insulin replacement 4
• Basal bolus therapy, consisting of a long-acting basal insulin and short-acting insulin with main meals, is commonly used to manage type 1 diabetes 4, 5

Insulin Therapies

• Long-acting insulin analogs, such as insulin glargine and insulin detemir, have been developed to optimize basal insulin therapy 4
• Insulin glargine U300 and insulin degludec provide non-inferior efficacy and reduce hypoglycemia risk compared to insulin glargine U100 4, 6
• Rapid-acting insulin analogs, such as aspart, glulisine, and lispro, are preferred for prandial glycemic control 5, 7

Treatment Strategies

• Continuous subcutaneous insulin infusion (CSII) is a treatment option for patients with type 1 diabetes who do not meet individual glycemic targets or experience frequent or severe hypoglycemia 5
• Continuous glucose monitoring (CGM) can improve glycemic control irrespective of treatment regimen 5
• A glycemic target of glycated hemoglobin <7% (53 mmol/mol) is appropriate for most nonpregnant adults with type 1 diabetes 5

Insulin Regimens

• Basal insulin analogs with a reduced peak profile and extended duration of action are preferred over neutral protamine Hagedorn (NPH) insulin 5, 7
• Premixed insulin preparations do not provide the flexibility to address individual needs of patients with type 1 diabetes 7
• Insulin degludec can be used as an alternative to insulin glargine or detemir, with a potential for lower doses and similar glycemic control 6, 8