Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study-STAT Study
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an investigator-initiated, prospective, randomized, multicenter, parallel,
      open-label, pilot clinical trial evaluating the efficacy of TI for PPBG, PPGE, and
      time-in-range on CGM download in patients with T1D. TI is an inhaled ultra-rapid-acting
      insulin, approved by the FDA for use in patients with diabetes. This is a pilot, real-life
      study where patients will continue their routine diabetes care and use post-meal correction
      dosages as deemed necessary for normalizing PPBG as per the protocol.

      This multi-center study will enroll 60 patients with T1D, A1c values between 6.5 to 10%. The
      patients will be randomized in 1:1 fashion to either TI or NL. Patients who are randomized
      into the NL arm will continue using their usual prandial insulin dose before meals. Patients
      who are randomized into the TI arm will be instructed to dose before the meals and take
      necessary corrections at 1- and 2-hours after meals to optimize PPBG (Table 1B). There will
      be a total of 7 study visits (screening visit, randomization visit, 2 clinic, and 3 phone
      visits). There will be a 4-week treatment comparison between TI and NL and 1-week of
      post-study follow up. (Phone visit; Figure-1). Standard lab tests (A1c, complete metabolic
      panel {CMP}, complete blood count {CBC}) will be performed at the screening visit.

      All patients will use real-time CGM (Dexcom G5®, San Diego, CA), which will be provided at
      the randomization visit for their day-to-day diabetes care. CGM data will be downloaded at
      every clinic visit on a secured computer. The data will be analyzed after the study for
      different primary and secondary end points. All patients will be allowed to keep the CGM
      after the study is over for their day-to-day diabetes care.
    


Intervention name(s): Technosphere insulin
Intervention type(s): Drug
Intervention description(s): This multi-center study will enroll 60 patients with T1D, A1c values between 6.5 to 10%. The patients will be randomized in 1:1 fashion to either TI or NL. Patients who are randomized into the NL arm will continue using their usual prandial insulin dose before meals. Patients who are randomized into the TI arm will be instructed to dose before the meals and take necessary corrections at 1- and 2-hours after meals to optimize PPBG (Table 1B). There will be a total of 7 study visits (screening visit, randomization visit, 2 clinic, and 3 phone visits). There will be a 4-week treatment comparison between TI and NL and 1-week of post-study follow up. (Phone visit; Figure-1). Standard lab tests (A1c, complete metabolic panel {CMP}, complete blood count {CBC}) will be performed at the screening visit.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; time in range; inhaled insulin; continuous glucose monitoring; type 1 diabetes; hypoglycemia; post prandial hypergylcemia