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

Type 1 Diabetes Clinical Trial

— UNIQUE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05118945
• Other study ID #: Unique_1_2021
• Status: Completed
• Start date: March 3, 2021
• Est. completion date: December 28, 2021

Study information

• Verified date: March 2022
• Source: Kinderkrankenhaus auf der Bult
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 28, 2021
• Est. primary completion date: December 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Insulin Therapy
• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Germany	Hospital for Children and Adolescents AUF DER BULT	Hanover	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Kinderkrankenhaus auf der Bult

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Secondary	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	two weeks
Secondary	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	12 weeks
Secondary	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.	two weeks
Secondary	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.	two weeks
Secondary	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.	12 weeks
Secondary	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.	two weeks