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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
Barbara Davis Center
Aurora, Colorado, United States
Change in Time in Range (%) (70-180 mg/dl) With TI on CGM
Difference between Time in range for TI group (treatment) and for Aspart group (control)
Time frame: 4 weeks
Change in Post-prandial Glucose Excursion (mg/dl) (1-4 Hours After Meals) With TI
Difference in postprandial blood glucose between treatment and control group
Time frame: 4 weeks
Change in Glucose Variability (GV) (mg/dl) (Standard Deviation and/or Coefficient Variation)
Difference of glucose variability metrics between treatment and control groups
Time frame: 4 weeks
The Area Under the Curve Calculation (AUC) (Min*mg/dl) in the PPBG and PPGE,
Difference of area under curve between treatment and control groups. ( 0 to 4 hours duration)
Time frame: 0, 1, 2, 3, 4 hours post-dose at 4 weeks
Change in HbA1c (%) in One-month Treatment
Difference in HbA1c between treatment and control group
Time frame: 4 weeks
Change in Above the Target Time (%) (>180 mg/dl) on CGM
Difference of time above range between treatment and control group
Time frame: 4 weeks
Hypoglycemia Frequency (%) (Below the Target <70mg/dl) on CGM
Difference of hypoglycemia frequency between treatment and control groups.
Time frame: 4 weeks
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