Study on the Use of the Insulin Pump Tandem X:2 With Control IQ Algorithm - Update

Study Overview
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Brief Summary
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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
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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.

Official Title
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Observational Study on the Use of the Insulin Pump Tandem X:2 With Control IQ Algorithm - Update

Conditions
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Type 1 Diabetes, Insulin Therapy

Intervention / Treatment
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* Device: Insulin pump Tandem: t:slim X2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: signed informed consent type 1 diabetes Age >6 years at least 10 IE daily total Insulin dose and 25 kg Body weight Group SWITCH: already user of t:slim X2 with Basal IQ Group START: Granting of the insulin pump t:slim X2 and DexCom G6 by the health insurance Exclusion Criteria: 1.Refusal of participation by the participant or a parent

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SWITCH group: Change from Basal IQ to Control IQ<br>The patients of the SWITCH group used the X:s insulin pump with the Basal IQ algorithm until the start of the study and switched to the Control IQ algorithm at study start. | Device: Insulin pump Tandem: t:slim X2<br>* 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.<br>* Other names: Insulin pump Tandem: t:slim X2 with Control IQ;|
| START group: Change from conservative therapy to Control IQ<br>The patients of the START group have a conservative Insulin therapy (MDI = multiple daily injections or CSII = Continuous subcutaneous insulin infusion) until the start of the study, but will switched to the Control IQ algorithm at study start. | Device: Insulin pump Tandem: t:slim X2<br>* 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.<br>* Other names: Insulin pump Tandem: t:slim X2 with Control IQ;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in glucose range 70 - 180mg/dl (%) | Both groups are evaluated together. Comparison of the time (%) in the glucose range 70 - 180mg/dl of the last two weeks of the study with the time in the target range two weeks before the start of the study. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| user satisfaction assessed by disabkids questionnaire for children and for parents | Comparison of both groups with regard to satisfaction via specific validated questionnaire at the start of the study | two weeks | 
| user satisfaction assessed by disabkids questionnaire for children and for parents | Evaluation of the satisfaction of users via specific validated questionnare at the beginning and the end of study | 12 weeks | 
| mean glucose level [mg/dl] | Comparison of the mean Glucose Level from glucose sensor [mg/dl] of the last two study weeks with the mean glucose Level two weeks before the start of the study. | two weeks | 
| mean glucose Level before study start [mg/dl] | Comparison of both groups concerning the mean glucose level of the two weeks before the start of the study. | two weeks | 
| mean daily insulin amount | Both groups are evaluated together. Comparison of the mean daily insulin amount (U/kgBW/d) (U/kgBW/d) of the last two study weeks with the insulin amount two weeks before the start of the study. | 12 weeks | 
| mean daily insulin amount before study start | Comparison of both groups concerning the mean daily insulin amount (U/kgBW/d) of the two weeks before the start of the study. | two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paediatrics, type 1 diabetes, closed loop, CSII (Continuous Subcutaneous Insulin Infusion)