Improving Post-Prandial Blood Glucose Control With Afrezza During Closed-Loop Therapy (NCT03234491) | Clinical Trial Compass
CompletedPhase 1
Improving Post-Prandial Blood Glucose Control With Afrezza During Closed-Loop Therapy
United States15 participantsStarted 2017-11-22
Plain-language summary
The study will be conducted in two phases; an in-patient meal study phase (Phase I) and an outpatient home study (Phase II). The two phase study design is chosen to enhance safety by testing the Afrezza Closed-Loop (CL) system in controlled in-clinic setting under study staff supervision before it could be investigated at the outpatient home setting. Phase II will not begin without the establishment of safety in Phase I.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* The age inclusion criterion is 18-29 years for phase I and 18-50y for phase II
* Previously diagnosed with Type 1 Diabetes Mellitus, as determined by the judgment of the Principal Investigator, based on clinical presentation and as documented in the clinic record (formal antibody or genetic testing will not be required).
* Diabetes duration at least 1 year.
* Willing to have an intravenous (IV) line inserted for frequent blood sampling and infusion of glucose.
* Hemoglobin A1c (HbA1c) ≤10%
* Speak and understand English.
Exclusion Criteria:
* HbA1c \>10.0% at the time of screening
* Insulin pump naïve subjects and subjects with unstable insulin dosing parameters requiring daily adjustments in insulin sensitivity factor, insulin to carbohydrate ratio and basal rates other than the established temporary rates that are determined to manage specific conditions such as exercise.
* History of an episode of severe hypoglycemia or Diabetic Ketoacidosis (DKA) requiring inpatient management within six months prior to the screening visit and/or subjects with history of clinician diagnosed hypoglycemia unawareness.
* History of recurrent DKA defined as more than three episodes of admissions for DKA during the past 12 months.
* Subjects requiring an insulin total daily dose \<0.1u/kg/day and \>3u/kg/day.
* History of physician diagnosis of asthma or any other clinically important pulmonary disease, or use of any medications to treat such conditions within the last…