The purpose of this study is to collect CGM, A1c and Quality of Life data in subjects with Type 2 diabetes before and after transitioning from Multiple Daily Injections to Basal plus Bolus with Afrezza® inhaled insulin. The primary objective is to evaluate the percentage of time spent in goal range without significant hypoglycemia. Additional objectives include evaluation of A1c and Quality of Life data. The expected outcomes are improvement of time in range, no change or improvement in A1c and favorable Quality of Life data
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Participants will be titrated from usual pre-meal insulin plus basal to Afrezza® inhaled insulin plus basal, and will continue on treatment for 14 weeks.
Diabetes and Glandular Disease Clinic, P.A.
San Antonio, Texas, United States
Time In Range
Evaluation of percentage of time spent in goal range, above (hyperglycemic range) and below (hypoglycemic range) via CGM system from visit week 2 baseline to final study visit with inhaled insulin (Afrezza®).
Time frame: Week 2 to End of Study
Hypoglycemia
Incidence of significant hypoglycemic events
Time frame: Week 2 to Week 16
Hemoglobin A1c
Evaluation of A1c from visit week 2 baseline to final study visit
Time frame: Week 2 to Week 16
Quality of Life Questionnaires
Evaluation of Diabetes Quality of Life Questionnaires from baseline to final study visit.
Time frame: Screening to Week 16
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