Secondary Analysis - Tandem t:slim X2 User Manual

Chapter 33 – Basal-IQ Technology Clinical Study Overview

33.6 Secondary Analysis

The secondary outcomes measures of the clinical study represent characteristics of the glucose profile including time spent in the
low (hypoglycemic) range, time spent high (hyperglycemic) range, and the time spent with glucose under control (between 70-180
mg/dL). In this table, the differences in the percent of time < 60 mg/dL, < 50 mg/dL, >250 mg/dL. The average glucose was similar
across treatment arms.
Table 7. Secondary Efficacy Outcomes (N=201)
Characteristic
Average glucose mg/dL
Overall Glucose Control
% glucose 70 – 80 mg/dL ± std deviation
% glucose < 60 mg/dL
Hypoglycemia
% glucose < 50 mg/dL
% glucose > 250 mg/dL
Hyperglycemia
% glucose > 180 mg/dL
a. Includes all subjects with at least one CGM glucose sensor reading in each treatment period.
304
a
Unit of Measure
± std deviation
median (quartiles)
median (quartiles)
median (quartiles)
average ± std deviation
Study Arm
(Basal-IQ Enabled)
159 ± 25
65% ± 15%*
0.9% (0.4%, 1.6%) 1.2% (0.6%, 2.7%)
0.2% (0.1%, 0.5%) 0.3% (0.1%, 0.7%)
8% (3%, 13%)
32% ± 15%
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Control Arm
(SAP)
159 ± 27
63% ± 15%
8% (3%, 16%)
33% ± 16%