An observational study in Type 1 Diabetes and Insulin Therapy, sponsored by Kinderkrankenhaus auf der Bult. Completed at 1 site in Germany. Open to participants aged 6 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Kinderkrankenhaus auf der Bult · Observational
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.
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.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's enrollment of 50 is below the median of 121 across 769 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Kinderkrankenhaus auf der Bult is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1.Refusal of participation by the participant or a parent
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
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
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.
Also known as: Insulin pump Tandem: t:slim X2 with Control IQ
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.
Time frame: 12 weeks
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: two weeks
Plan to share: No
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Kinderkrankenhaus auf der Bult