NCT05118945

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Kinderkrankenhaus auf der Bult · Academic / Other
• Sex: All
• Age: 6 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes
• Insulin Therapy

Interventions

Type	Name	Description
DEVICE	Insulin pump Tandem: t:slim X2	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.

Timeline

• Start date: 2021-03-03
• Primary completion: 2021-12-28
• Completion: 2021-12-28
• First posted: 2021-11-12
• Last updated: 2024-09-19

Locations

1 site across 1 country: Germany