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

Completed

• Conditions: Insulin Therapy; Type 1 Diabetes

• Registration Number: NCT05118945
• Lead Sponsor: Kinderkrankenhaus auf der Bult

Brief 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.

Study Timeline

• Study Start: 2021-03-03
• Study First Submitted: 2021-10-12
• Study First Submitted QC: 2021-11-03
• Study First Posted: 2021-11-12
• Primary Completion: 2021-12-28
• Study Completion: 2021-12-28
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. signed informed consent
2. type 1 diabetes
3. Age >6 years
4. at least 10 IE daily total Insulin dose and 25 kg Body weight
5. Group SWITCH: already user of t:slim X2 with Basal IQ
6. 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time in glucose range 70 - 180mg/dl (%)	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
mean daily insulin amount	12 weeks	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.
mean daily insulin amount before study start	two weeks	Comparison of both groups concerning the mean daily insulin amount (U/kgBW/d) of the two weeks before the start of the study.
user satisfaction assessed by disabkids questionnaire for children and for parents	12 weeks	Evaluation of the satisfaction of users via specific validated questionnare at the beginning and the end of study
mean glucose Level before study start [mg/dl]	two weeks	Comparison of both groups concerning the mean glucose level of the two weeks before the start of the study.
mean glucose level [mg/dl]	two weeks	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.

Trial Locations

Locations (1)

Hospital for Children and Adolescents AUF DER BULT; 🇩🇪 Hanover, Lower Saxony, Germany