Clinical trial NCT05118945: Study on the Use of the Insulin Pump Tandem X:2 With Control IQ Algorithm - Update
Official title: Observational Study on the Use of the Insulin Pump Tandem X:2 With Control IQ Algorithm - Update
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Insulin Therapy
Keywords: paediatrics
type 1 diabetes
closed loop
CSII (Continuous Subcutaneous Insulin Infusion)
Lead sponsor: Kinderkrankenhaus auf der Bult
Sponsor class: OTHER
First posted: 2021-11-12
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time in glucose range 70 - 180mg/dl (%)
timeFrame: 12 weeks
Secondary outcomes:
measure: user satisfaction assessed by disabkids questionnaire for children and for parents
timeFrame: two weeks
measure: user satisfaction assessed by disabkids questionnaire for children and for parents
timeFrame: 12 weeks
measure: mean glucose level [mg/dl]
timeFrame: two weeks
measure: mean glucose Level before study start [mg/dl]
timeFrame: two weeks
measure: mean daily insulin amount
timeFrame: 12 weeks
measure: mean daily insulin amount before study start
timeFrame: two weeks
Other outcomes:
Locations:
city: Hanover
country: Germany
facility: Hospital for Children and Adolescents AUF DER BULT
state: Lower Saxony
Study officials:
affiliation: Hospital for Children and Adolescents AUF DER BULT
name: Torben Biester, Dr.
role: PRINCIPAL_INVESTIGATOR
References: