From the Guidelines
Type 1 Diabetes Mellitus (T1DM) typically presents with signs of autoimmune destruction of the pancreatic b-cells, including the presence of autoantibodies and normoglycemia in stage 1, dysglycemia in stage 2, and overt hyperglycemia in stage 3, as outlined in the 2025 standards of care in diabetes 1. The signs of T1DM can be categorized into three stages, with stage 1 characterized by the presence of two or more autoantibodies and normoglycemia, stage 2 characterized by multiple islet autoantibodies and dysglycemia, and stage 3 characterized by overt hyperglycemia and symptoms such as polyuria, polydipsia, and weight loss. Some key characteristics of each stage include:
- Stage 1:
- Autoimmunity
- Normoglycemia
- Presymptomatic
- Diagnostic criteria: multiple islet autoantibodies, no impaired glucose tolerance (IGT) or impaired fasting glucose (IFG), normal A1C
- Stage 2:
- Autoimmunity
- Dysglycemia
- Presymptomatic
- Diagnostic criteria: islet autoantibodies, IFG: fasting plasma glucose (FPG) 100–125 mg/dL, IGT: 2-h plasma glucose 140–199 mg/dL, A1C 5.7–6.4%
- Stage 3:
- Autoimmunity
- Overt hyperglycemia
- Symptomatic
- Diagnostic criteria: autoantibodies may become absent, diabetes by standard criteria It is essential to note that the rate of b-cell destruction can vary significantly among individuals, and some may present with diabetic ketoacidosis (DKA) as the first manifestation of the disease, while others may have a more gradual onset of symptoms 1. In clinical practice, it is crucial to monitor individuals with presymptomatic T1DM regularly, as the risk of developing symptomatic T1DM can be high, with a 44% risk overall at stage 1 and a 60% risk by 2 years and 75% risk within 5 years at stage 2 1.
From the FDA Drug Label
The type 1 diabetes population had the following characteristics: the mean age was 39 years, 54% were male, and mean body mass index (BMI) was 25. 1 kg/m2. The frequencies of adverse reactions during Insulin Glargine clinical studies in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below (Tables 1,2,3, and 4)
The signs of Type 1 Diabetes Mellitus (T1DM) are not directly stated in the provided drug label. However, based on the information provided about the type 1 diabetes population and the adverse reactions, hypoglycemia is a commonly observed adverse reaction in patients treated with Insulin Glargine.
- Severe symptomatic hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose below 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration.
- The label does not provide direct information on the signs of T1DM, but it does discuss the characteristics of the type 1 diabetes population and the adverse reactions associated with Insulin Glargine treatment 2.
From the Research
Signs and Symptoms of Type 1 Diabetes Mellitus (T1DM)
- The signs and symptoms of T1DM are not explicitly stated in the provided studies, but the disease is characterized by insulin deficiency due to pancreatic β-cell loss, leading to hyperglycaemia 3.
- Hyperglycaemia-associated symptoms, such as polyuria and thirst, are common indicators of the disease 3.
- The pathogenesis of T1DM can be divided into three stages, depending on the absence or presence of hyperglycaemia and hyperglycaemia-associated symptoms 3.
- Islet-targeting autoantibodies, which target proteins associated with secretory granules in β-cells, are biomarkers of T1DM-associated autoimmunity and can be used to identify individuals at risk of developing T1DM 3.
Presymptomatic T1DM
- Presymptomatic T1DM individuals can be identified through screening for autoantibodies, and monitoring strategies can be implemented to reduce the risk of diabetic ketoacidosis (DKA) at diagnosis 4.
- Recommended monitoring approaches include biannual assessments of random plasma glucose and HbA1c for children, and annual assessments for adolescents and adults 4.
- Continuous glucose monitoring and repeat oral glucose tolerance tests (OGTT) may also be valuable tools in monitoring presymptomatic T1DM individuals 4.
Clinical Presentation
- T1DM can present at any age, although symptomatic onset is usually during childhood or adolescence 3.
- The disease is characterized by a chronic progression, with symptoms developing over time as pancreatic β-cell loss occurs 3.
- Clinical care and monitoring strategies are essential to mitigate the risk of complications, such as DKA, and to improve the quality of life and prognosis of individuals with T1DM 4, 3.