The main purpose of this study is to estimate missed bolus insulin doses in diabetics. This is a 12-week, single-arm, outpatient, exploratory study with two study periods in Type 1 or Type 2 diabetics, with an investigational reusable injection pen, insulin, and a Continuous Glucose Monitoring (CGM) device.
Study Type
OBSERVATIONAL
Enrollment
79
Commercially available
As prescribed.
AMCR Institute, Inc.
Escondido, California, United States
Science 37 Inc
Los Angeles, California, United States
Coastal Metabolic Research Ctr
Ventura, California, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States
Average Number of Days Per Month With a Missed Bolus Insulin Dose With Blinded CGM
The average number of days per month with a missed bolus insulin dose was calculated in participants with Type 1 Diabetes or Type 2 Diabetes using blinded CGM measurements and the pen. The time of insulin dosing and glucose excursions were assessed using the display times recorded by the pen and CGM devices, respectively.
Time frame: Week 1 up to 6 weeks
Average Number of Days Per Month With a Missed Bolus Insulin Dose With Unblinded CGM
The average number of days per month with a missed bolus insulin dose was calculated in participants with Type 1 Diabetes or Type 2 Diabetes using unblinded CGM measurements and the pen. The time of insulin dosing and glucose excursions were assessed using the display times recorded by the pen and CGM devices, respectively
Time frame: Week 6 up to 12 weeks
Percentage of Time-in-Range (Glucose >70 and ≤180 Milligrams Per Deciliter) With Blinded CGM
Percentage of time-in-range (glucose \>70 and ≤180 milligrams per deciliter) was calculated in participants with Type 1 Diabetes or Type 2 Diabetes based on blinded CGM data collected in the study period. The time component of the time-in-range statistic was calculated using the display time recorded by the CGM device.
Time frame: Baseline up to 6 weeks
Percentage of Time-in-Range (Glucose >70 and ≤180 Milligrams Per Deciliter) With Unblinded CGM
Percentage of time-in-range (glucose \>70 and ≤180 milligrams per deciliter) was calculated in participants with Type 1 Diabetes or Type 2 Diabetes based on unblinded CGM data collected in the study period. The time component of the time-in-range statistic was calculated using the display time recorded by the CGM device.
Time frame: Week 6 up to 12 weeks
Percentage of Missed Bolus Doses Per Month With Blinded CGM
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Iowa Diabetes & Endocrinology Research Center
West Des Moines, Iowa, United States
Advanced Research Institute
Ogden, Utah, United States
Percentage of missed bolus doses per month was estimated in participants with Type 1 diabetes or Type 2 diabetes using blinded CGM measurements and the pen.
Time frame: Baseline up to 6 weeks
Percentage of Missed Bolus Doses Per Month With Unblinded CGM
Percentage of missed bolus doses per month was estimated in participants with Type 1 diabetes or Type 2 diabetes using unblinded CGM measurements and the pen.
Time frame: Week 6 up to 12 weeks
Average Number of Missed Bolus Insulin Doses Per Day With Blinded CGM
The average number of missed bolus doses per day was estimated in participants with Type 1 diabetes or Type 2 diabetes using blinded CGM measurements and the pen.
Time frame: Baseline up to 6 weeks
Average Number of Missed Bolus Insulin Doses Per Day With Unblinded CGM
The average number of missed bolus doses per day was estimated in participants with Type 1 diabetes or Type 2 diabetes using unblinded CGM data.
Time frame: Week 6 up to 12 weeks
Average Number of Missed and Suboptimal Bolus Dose (MSBD) Events Per Month With Blinded CGM
The number of Missed and Suboptimal Doses (MSBDs) per month was calculated in participants with Type 1 Diabetes or Type 2 Diabetes as the sum of the identified missed bolus doses and suboptimal bolus doses for each participant for each period.
Time frame: Baseline up to 6 weeks
Average Number of Missed and Suboptimal Bolus Dose (MSBD) Events Per Month With Unblinded CGM
The number of Missed and Suboptimal Doses (MSBDs) per month was calculated in participants with Type 1 Diabetes or Type 2 Diabetes as the sum of the identified missed bolus doses and suboptimal bolus doses for each participant for each period.
Time frame: Week 6 up to 12 weeks