Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients
To examine the effects of adding prandial Afrezza inhaled insulin to patients with type 2 diabetes who are not controlled after at least 6 months of other diabetes treatments including oral agents, basal insulin, or GLP-1 use.
Clinical inertia in intensifying treatment of type 2 diabetes patients occurs in the range of 70% in numerous real world database assessments. The investigator proposes treating patients with Afrezza who have an index HbA1c between 7.5% and 11.5% despite being treated with diabetes medications for at least 6 months. The response to Afrezza will be assessed with Continuous Glucose Monitoring Systems (CGMS) studies and initial and follow-up HbA1cs. The goal is to assess how the investigator can rapidly and safely initiate intensification in this patient population, where extensive delays in HbA1c improvement often occur.
Patients will be instructed to follow a Weekly Treat-to-Target BG Testing Regimen and make Afrezza dose changes according to an Afrezza Titration Algorithm
Inclusion Criteria: Adult type 2 diabetes patients age 18 or older HbA1c ≥ 7.5% and ≤ 11.5% after at least 6 months treatment with diabetes medication. Treatment may include oral agents, basal insulin or GLP-1 in any combination. Patient and provider agree not to add additional diabetes medications during the 14 weeks of the study (unless rescue treatment is indicated). Exclusion Criteria: History of asthma, COPD or smoking within 6 months FEV1 under 70% predicted Pregnancy Active malignancies and/or life expectancy of < 12 months Major surgery planned during study period Currently using rapid acting insulins - Novolog, Humalog, Apidra Prior use of Afrezza in the last 3 months Unwilling to test blood glucose before or after each meal Exposure to systemic glucocorticoids within 6 weeks of screening Severe hypoglycemia in last 6 months or hypoglycemia unawareness Any medical condition which, in the opinion of the PI, would interfere with ability to understand or respond to the administration of inhaled insulin