Clinical Trial: INHALE-3: Afrezza® Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes
Study Status: NOT_YET_RECRUITING
Recruit Status: NOT_YET_RECRUITING
Condition: Diabetes Mellitus, Type 1
Study Type: INTERVENTIONAL
Official Title: INHALE-3: A 17-Week Randomized Trial and a 13-Week Extension, Evaluating the Efficacy and Safety of Inhaled Insulin (Afrezza) Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Dia
Brief Summary:
INHALE-3 is a Phase 4, randomized controlled trial (RCT) that will randomly assign participants ?18 years of age with type 1 diabetes (T1D) using multiple daily injections (MDI), an automated insulin delivery (AID) system, or a pump without automation, and continuous glucose monitoring (CGM) 1:1 to an insulin regimen of insulin degludec plus inhaled insulin (Afrezza) and CGM or continuation of usual care.The primary outcome of the RCT is at 17 weeks.The RCT will be followed by a 13-week extension phase in which…
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