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

Children's Hospital Auf der Bult

Status: Completed

Conditions: Type 1 Diabetes; Insulin Therapy

Treatments: Device: Insulin pump Tandem: t:slim X2

Study type: Observational

Funder types: Other

Identifiers

NCT05118945

Unique_1_2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 6 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

SWITCH group: Change from Basal IQ to Control IQ

Description:

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.

Treatment:

Device: Insulin pump Tandem: t:slim X2

START group: Change from conservative therapy to Control IQ

Description:

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.

Treatment:

Device: Insulin pump Tandem: t:slim X2