What evidence supports a diagnosis of uncontrolled chronic type 2 diabetes mellitus (T2DM)?

From the Guidelines

Diagnosing uncontrolled chronic type 2 diabetes is supported by evidence of elevated hemoglobin A1C levels above 7% (or individualized targets), as recommended by the American College of Physicians guidance statement 1.

Key Indicators

• Elevated hemoglobin A1C levels above 7% (or individualized targets)
• Persistent fasting blood glucose readings above 130 mg/dL
• Post-prandial glucose levels exceeding 180 mg/dL despite treatment
• Presence of symptoms such as polyuria, polydipsia, unexplained weight loss, recurrent infections, and poor wound healing
• Diabetes complications like retinopathy, nephropathy, or neuropathy
• Laboratory findings including glycosuria, ketonuria, and elevated fructosamine levels

Considerations

• Medication adherence issues
• Inadequate medication regimens or treatment resistance
• Patient reports of worsening symptoms or lack of improvement
• Presence of comorbidities affecting glucose control, such as obesity or stress
• Impact of concurrent medications like steroids on blood glucose levels The American College of Physicians guidance statement 1 emphasizes the importance of individualizing HbA1c targets based on patient characteristics, such as comorbid conditions and risk for hypoglycemia.

Guidance Statements

• Guidance Statement 1: Clinicians should personalize goals for glycemic control in patients with type 2 diabetes on the basis of a discussion of benefits and harms of pharmacotherapy, patients' preferences, patients' general health and life expectancy, treatment burden, and costs of care 1.
• Guidance Statement 2: Clinicians should aim to achieve an HbA1c level between 7% and 8% in most patients with type 2 diabetes 1.
• Guidance Statement 3: Clinicians should consider deintensifying pharmacologic therapy in patients with type 2 diabetes who achieve HbA1c levels less than 6.5% 1.
• Guidance Statement 4: Clinicians should treat patients with type 2 diabetes to minimize symptoms related to hyperglycemia and avoid targeting an HbA1c level in patients with a life expectancy less than 10 years due to advanced age (80 years or older), residence in a nursing home, or chronic conditions (such as dementia, cancer, end-stage kidney disease, or severe chronic obstructive pulmonary disease or congestive heart failure) because the harms outweigh the benefits in this population 1. By considering these factors and following the guidance statements, clinicians can make informed decisions about diagnosing and managing uncontrolled chronic type 2 diabetes.

From the FDA Drug Label

At the end of treatment, INVOKANA provided statistically significant improvements from baseline relative to placebo in HbA 1C(p<0.001 for both doses) of -0.57% (95% CI: -0.71%; -0.44%) for INVOKANA 100 mg and -0.70% (95% CI: -0.84%; -0. 57%) for INVOKANA 300 mg HbA 1C(%) Baseline (mean)8.208.338.27 Change from baseline (adjusted mean)0.01-0.63-0.72 Difference from placebo (adjusted mean) (95% CI) †-0.65 ‡ (-0.73; -0.56) -0.73 ‡ (-0.82; -0. 65) The mean HbA 1Cat baseline was 8. 0% HbA 1C(%) Baseline (mean)8.37.8 Change from baseline †‡0.34-0.38 Difference from placebo 95% CI †‡-0.73 (-1.26, -0.19)

The supporting evidence for making a diagnosis of uncontrolled chronic type 2 diabetes includes:

• Elevated HbA1C levels: Baseline HbA1C levels ranged from 8.0% to 8.3%, indicating uncontrolled diabetes.
• Inadequate response to current therapy: Patients were inadequately controlled on current diabetes therapy, including diet, exercise, and/or antihyperglycemic agents.
• High Fasting Plasma Glucose (FPG) levels: Baseline FPG levels ranged from 154.8 to 169 mg/dL, indicating hyperglycemia. The evidence suggests that these patients have uncontrolled type 2 diabetes, as indicated by elevated HbA1C and FPG levels, despite being on current diabetes therapy 2.

From the Research

Diagnosis of Uncontrolled Chronic Type 2 Diabetes

The diagnosis of uncontrolled chronic type 2 diabetes can be supported by several factors, including:

• Elevated hemoglobin A1c (HbA1c) levels, indicating poor glucose control over time 3, 4
• High fasting blood glucose (FBG) and post-prandial blood glucose (PPBG) levels, suggesting inadequate glucose regulation 3, 4
• Presence of microvascular complications, such as nephropathy, retinopathy, or neuropathy, which can occur as a result of prolonged hyperglycemia 3
• Cardiovascular risks, including hypertension, dyslipidemia, and a history of cardiovascular disease, which are commonly associated with type 2 diabetes 3, 5

Treatment Options for Uncontrolled Type 2 Diabetes

Treatment options for uncontrolled type 2 diabetes may include:

• Intensification of insulin therapy, which can be achieved through the use of basal insulin, premix insulin regimens, or rapid-acting prandial insulin doses 5, 6
• Addition of oral antidiabetic agents, such as sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, or incretin-based therapies, to improve glucose control 3, 4
• Combination therapy, which involves the use of multiple medications with different mechanisms of action to target multiple pathogenic mechanisms simultaneously 7
• Lifestyle modifications, including diet, exercise, and weight loss, which can help improve glucose control and reduce cardiovascular risk factors 7

Factors to Consider in Diagnosis and Treatment

When diagnosing and treating uncontrolled type 2 diabetes, several factors should be considered, including:

• Patient-specific factors, such as cardiovascular risks, risk of hypoglycemia, metabolic changes, and cost 3
• The potential benefits and limitations of different treatment options, including their efficacy, safety, and potential side effects 3, 5, 4
• The importance of individualized treatment approaches, which take into account the unique needs and circumstances of each patient 7