Study on the Use of the Insulin Pump Tandem X:2 With Control IQ Algorithm - Update
Condition: Type 1 Diabetes; Insulin Therapy
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The aim of this observational clinical trial is to obtain data on the safety, efficacy and
      satisfaction of the Tandem T:Slim X:2 Pump System in patients with type 1 diabetes.
    

Detailed description: 
      This is a non-randomized, non-blinded, prospective, observational single-center study,
      enrolling 2x 25 subjects in two cohorts (25 subjects in SWITCH group and 25 subjects in START
      group) with diabetes mellitus for up to 12 weeks. The study will evaluate the effectiveness
      of the insulin therapy with the pump system Tandem t:slim X:2 with the special algorithm
      "Control IQ" in comparison to each other. The test system including the Control IQ software
      will provide an Hybrid-Closed loop - Modus, which can predict the future tissue glucose value
      and continuously adjust the insulin infusion according to need. The aim is to keep the
      glucose value permanently within the target range and to avoid hypoglycaemia or
      hyperglycaemia.

      Group START starts from any other diabetes therapy (MDI, PLGM (=Predictive Low Glucose
      Suspend), SaP (=Sensor augmented Pump)) directly to T:Slim pump with control IQ; group SWITCH
      switches from former use of T:slim with Basal IQ.

      The study includes two visits only (start and end). At the beginning all patients have to
      complete questionnaires, and the data of the glucose sensor are read out and the metric data
      are determined and laid down.

      Depending on the previous form of therapy, the patients are assigned to the corresponding
      cohort. All participants and parents, regardless of which cohort, receive a technical
      briefing from the study team as well as training on how to use the new system or algorithm.
      Subsequently, the system will be applied in everyday life in the coming weeks. After 12 weeks
      (end of study), the insulin pump is read out and the questionnaire on satisfaction with the
      device is filled out again.

      After the end of the study, the patients participate in standard medical care as before.
    

Intervention name(s): Insulin pump Tandem: t:slim X2
Intervention type(s): Device
Intervention description(s): Insulin pump with Hybrid-Closed Loop - Modus. The insulin pump t:slim X2 from the manufacturer Tandem, in cooperation with the glucose sensor DexCom G6, has the option of using an algorithm called "control IQ", which controls the insulin delivery semi-automatically by means of an MPC algorithm. For this purpose, the insulin basal delivery can be increased or decreased by the system. Furthermore, automatic bolus deliveries, which are possible in the amount of up to 60% of a manual correction, can be delivered.
Other intervention name(s): Insulin pump Tandem: t:slim X2 with Control IQ
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients over 6 years of age with type 1 Diabetes and Insulin therapy (MDI or CSII).

        The START group is heterogeneous, but it should be ensured that all patients in the start
        group do not use a close loop system so far.

        Furthermore, a maximum of 30 % of the patients in the START group should use the same pump
        system to ensure that the weighting of a single pump system does not become too strong.
      
Keywords: paediatrics; type 1 diabetes; closed loop; CSII (Continuous Subcutaneous Insulin Infusion)