Introduction; Clinical Study Overview - Tandem t:slim X2 User Manual

CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies

32.1 Introduction

The following data represents the
clinical performance of the t:slim X2™
insulin pump with Control-IQ™
technology in two studies. The first
pivotal study (the DCLP3) included
participants ≥14 years old. A second
pivotal study (the DCLP5) included
participants ≥6 years to 13 years old. In
both studies, the t:slim X2 insulin pump
with Control-IQ technology was
compared to Sensor Augmented Pump
(SAP) therapy alone (the control group).
All participants in both studies used the
Dexcom G6 CGM.

32.2 Clinical Study Overview

The goal of both the DCLP3 and the
DCLP5 study was to assess the safety
and efficacy of Control-IQ technology
when used 24-hours a day for 4 to
6-months under normal conditions. The
system performance was evaluated in
these two randomized controlled trials
comparing the use of Control-IQ
technology to the use of SAP over the
same period of time. The two study
288
protocols were very similar. In the
DCLP3, participants (N=168) were
randomly assigned to use Control-IQ
technology or SAP for the study in a 2:1
ratio. The Control-IQ technology group
included 112 participants, and the SAP
group included 56 participants. All 168
participants completed the trial. The
study population consisted of patients
with a clinical diagnosis of type 1
diabetes, 14 to 71 years of age, treated
with insulin via an insulin pump or
injections for at least one year. Females
known to be pregnant were not
included. The summary statistics
presented for the DCLP3 describe the
primary outcome measure of the
sensor glucose time in range between
70–180 mg/dL, reported by treatment
group. Analysis of the secondary
endpoints and additional metrics was
also performed.
In the DCLP5, participants (N=101)
were randomly assigned to Control-IQ
technology or SAP in a 3:1 ratio. In this
study, the Control-IQ technology group
included 78 participants, and the SAP
group included 23 participants. The
study population was similar to the
DCLP5 in that participants had a clinical
diagnosis of type 1 diabetes, but they
were younger; 6 to 13 years of age.
They were treated with insulin via an
insulin pump or injections for at least
one year. They weighed ≥25 kg and
≤140 kg and took at least 10 units of
insulin/day. Females known to be
pregnant were not included.
Participants were required to be living
with at least one parent or guardian
knowledgeable about diabetes and
managing diabetes-related
emergencies and willing to participate
in all training sessions. No participants
with the following conditions were
enrolled in the DCLP5 study:
• Inpatient psychiatric treatment in
the past 6 months
• Presence of a known adrenal
disorder
• Untreated thyroid disease
• Cystic fibrosis
• Severe infectious process not
anticipated to resolve prior to study
procedures (e.g. meningitis,
pneumonia, osteomyelitis)