Assessing the Impact of Control-IQ Technology
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      This is a single-centre, mixed-methods, prospective study in pediatric patients with T1D
      initiating Control-IQ technology on the Tandem t-slim X2 insulin pump.

      Primary Objective:

      To determine pediatric T1D patients' and their parents' perceptions of the impact of
      Control-IQ on their psychosocial functioning and quality of life.
    

Detailed description: 
      Background Information & Rationale

      The management of type 1 diabetes (T1D) is rapidly evolving to offer technology that aims to
      improve metabolic control and decrease the burden of diabetes management. Hybrid-closed loop
      systems are at the forefront of this technology. They are comprised of an insulin pump and
      continuous glucose monitoring (CGM) system that interface in order to automatically adjust
      the delivery of basal insulin through the pump, based on CGM data. Insulin boluses for meals
      and snacks must still be entered manually by the user.

      Studies of hybrid closed loop systems have primarily focused on clinical trials that show
      improved glycemic outcomes.1-3 Few studies have assessed real-world glycemic outcomes or
      patient-reported outcomes, and none have focused on a pediatric population.

      A recent study published by Pinsker et al.4 showed improvement in psychosocial outcomes and
      persistent achievement of glycemic targets in a real-world setting in adults with T1D using
      the Tandem t:slim X2 pump with Control-IQ technology.

      The Tandem t:slim X2 pump with Control-IQ is a hybrid closed loop system (using Dexcom G6
      CGM) that has recently been approved for use by Health Canada, but has been used in the U.S.
      for the last year. This new technology will launch in Canada in March 2021, at which time
      existing Tandem t:slim X2 insulin pump users (with concurrent CGM use) will be able to
      upgrade their insulin pump software to access this technology (following review of an online
      module).

      The Children's Hospital of Eastern Ontario (CHEO), is located in Ottawa, ON Canada. CHEO
      follows approximately 800 children with diabetes, approximately 85 of whom are managed on the
      Tandem t:slim X2 pump with concurrent Dexcom G6 CGM use.

      The upcoming launch of Control-IQ presents a unique opportunity to gain a better
      understanding of the real-world impact of this technology on our Canadian pediatric
      population. The benefits of conducting this study in our population are two-fold:

        1. The Canadian context offers the study a diverse patient population given our universal
           healthcare system and provincially-funded insulin pump program. Because pumps and
           supplies are funded by the government, they are available to all of our patients,
           regardless of socio-economic status and whether or not they have private health
           insurance.

        2. Studying a pediatric population offers the unique perspective of children and youth (and
           their parents) whose management practices and goals differ from those of adults. While
           adult patients and parents of children with T1D are motivated by attaining glycemic
           targets for long term health outcomes, children and youth live in moment with emphasis
           on how they feel now. As such, patient reported outcomes, while important to all ages,
           are often the most important motivator for children and youth when choosing a treatment
           regimen.

      Study Design This is a single-centre, mixed-methods, prospective study in pediatric patients
      with T1D initiating Control-IQ technology on the Tandem t-slim X2 insulin pump.

      Participants will enroll in the study prior to initiating use of Control-IQ on their Tandem
      insulin pump.

      Recruitment will occur over an eight-week period starting mid-March 2021. Participation in
      this study will last 16 weeks.

      Study Objectives

      Primary Objective: To determine pediatric T1D patients' and their parents' perceptions of the
      impact of Control-IQ on their psychosocial functioning and quality of life (as measured by
      the INSPIRE Questionnaire, post assessment).

      Secondary Objectives:

        1. To assess the effect of Control-IQ technology on other patient and parent reported
           outcomes (PROs) including:

             -  Diabetes Impact and Device Satisfaction (DIDS) scale,

             -  Hypoglycemia Fear Survey (child and parent version),

             -  WHO-5 (emotional well-being)

        2. To determine the impact of Control-IQ technology on glycemic control in pediatric T1D
           patients who are experienced sensor-augmented pump users.

      Exploratory Objectives:

        1. To explore the effect of Control-IQ technology on patient and parents' sleep, school,
           activities/ sports, mood and family dynamics.

        2. To explore whether or not youth and parents' expectations of Control-IQ align with their
           experience of using this this automated insulin delivery system.

      Participant Characteristics:

      The following data will be collected from each chart at baseline:

        -  Date of birth

        -  Gender

        -  Date of T1D diagnosis

        -  Date of initiation of insulin pump therapy

             -  Date of first insulin pump start

             -  Date of Tandem t:slim X2 pump start

        -  Current use of CGM (yes/ no)

        -  Last measured HbA1c ( if available within the last 3 months

        -  Number of hospitalizations due to diabetes complications within the past year

      Sociodemographic measures will be collected by questionnaire at baseline, including:

        -  Family structure

        -  Parental education - highest level achieved

        -  Household income

        -  Private health insurance

        -  Ethnicity (self-reported)

      Statistical Plan The patient population will be described using descriptive statistics. The
      study team will compare patient reported outcomes, measures of glycemic control, and measures
      of insulin pump management pre and 16 weeks post-initiation of Control-IQ technology, using
      paired t-test and Wilcoxon signed-rank test, depending on the distributional characteristics
      of the outcomes. Analysis of open-ended questions will be done by a qualitative research
      specialist.

      Sample Size Determination CHEO currently has 85 patients on the Tandem t:slim X2 pump with
      CGM, with an estimated 10-15 patients more estimated to start before March 2021.
      Historically, the patient population at CHEO has been highly engaged with research with an
      anticipated participation rate of 90-95%. The Investigator expects that recruitment rates
      would be similar for this study, allowing for a sample size of 70 participants.

      This sample size is sufficient to provide > 80% power for detecting a "medium size" effect
      (Cohen's d = 0.5), which corresponds to a mean score of 70 from the post assessment INSPIRE
      Questionnaire, 10 units larger than a mean score of 60 (the null hypothesis). Cohen's d is
      expressed by the ratio of the mean difference over the standard deviation. Here, we use sd =
      20 as an estimate of the standard deviation of the score, which is conservative considering
      previously presented estimates (e.g. sd = 16.44 described in Weissberg-Benchell et al [5]).
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children and youth with T1D followed at CHEO will be invited to participate in the study.