Is type 1 diabetes a contraindication for taking Jardiance (empagliflozin) for heart failure?

Is Type 1 Diabetes a Contraindication for Jardiance in Heart Failure?

Type 1 diabetes is NOT an absolute contraindication for Jardiance (empagliflozin) in heart failure, but it is explicitly not recommended by the FDA and carries substantially elevated risk of diabetic ketoacidosis that requires extreme caution and intensive monitoring. 1

FDA Labeling and Official Recommendations

The FDA label for Jardiance explicitly states: "JARDIANCE is not recommended for patients with type 1 diabetes" under Limitations of Use. 1 This is a critical distinction—it is not listed as an absolute contraindication (which includes only severe renal impairment/ESRD/dialysis and serious hypersensitivity reactions), but rather as "not recommended." 1

Evidence Base and Clinical Context

Why Type 1 Diabetes Poses Unique Risks

• All major cardiovascular and heart failure outcomes trials (EMPA-REG OUTCOME, EMPEROR-Reduced, EMPEROR-Preserved, DAPA-HF) specifically excluded patients with type 1 diabetes, meaning there is no high-quality evidence supporting safety or efficacy in this population. 2

• The American Diabetes Association guidelines explicitly note that cardiovascular and heart failure trials "excluded individuals with type 1 diabetes and/or recent history of diabetic ketoacidosis," highlighting the recognized elevated risk in this population. 2

Diabetic Ketoacidosis Risk

The risk of diabetic ketoacidosis with SGLT2 inhibitors is substantially higher in type 1 diabetes compared to type 2 diabetes. 2, 3 Key mechanistic factors include:

• Increased ketone production due to insulin deficiency (inherent in type 1 diabetes) 2
• Increased glucagon levels leading to enhanced lipolysis and ketogenesis 2
• Decreased renal clearance of ketones 2
• Euglycemic presentation (blood glucose often <250 mg/dL), which delays recognition and treatment 1

Pharmacovigilance data confirms ketoacidosis has significantly higher reporting probability in diabetes cases (ROR: 5.95%CI: 4.87-7.26) compared to heart failure alone. 3

Clinical Decision Algorithm

If Considering Empagliflozin in Type 1 Diabetes with Heart Failure:

Step 1: Assess Absolute Contraindications

• eGFR <20 mL/min/1.73m² 4, 1
• History of serious hypersensitivity to empagliflozin 1
• Severe renal impairment, ESRD, or dialysis 1

Step 2: Evaluate Ketoacidosis Susceptibility

• History of diabetic ketoacidosis (high risk) 2
• Insulin pump use or frequent pump malfunctions 2
• History of significant insulin dose reductions 2
• Pancreatic disorders or history of pancreatitis 1
• Alcohol abuse 1
• Frequent prolonged fasting or severe carbohydrate restriction 2, 1

Step 3: Risk-Benefit Assessment

• The heart failure mortality benefit is substantial (21-26% reduction in cardiovascular death or heart failure hospitalization) 5, 4
• However, this benefit is established only in type 2 diabetes and non-diabetic heart failure patients 2, 6
• No evidence exists for type 1 diabetes, making this entirely off-label use 2

Step 4: If Proceeding Despite Risks

• Provide intensive education on ketoacidosis recognition (nausea, vomiting, abdominal pain, malaise, shortness of breath—even with normal glucose) 1
• Never reduce basal insulin doses when initiating empagliflozin 2
• Monitor ketones regularly, especially during illness, fasting, or surgery 2, 1
• Discontinue empagliflozin 3-4 days before any scheduled surgery 7
• Establish clear sick-day management protocols 2

Common Pitfalls to Avoid

• Assuming normal blood glucose rules out ketoacidosis—euglycemic DKA is the typical presentation with SGLT2 inhibitors 1
• Reducing insulin doses after starting empagliflozin, which dramatically increases ketoacidosis risk 2
• Continuing empagliflozin during acute illness or prolonged fasting without ketone monitoring 1
• Failing to educate patients on atypical ketoacidosis presentation 1

Bottom Line

Given the FDA's explicit statement that Jardiance is "not recommended" for type 1 diabetes, the complete absence of clinical trial data in this population, and the substantially elevated ketoacidosis risk, empagliflozin should NOT be routinely used in type 1 diabetes patients with heart failure. 2, 1 If considered in exceptional circumstances where heart failure severity justifies the risk, this requires informed consent, intensive monitoring, and meticulous ketoacidosis prevention strategies. 2, 7, 1