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Completed

NCT Number: NCT05118945

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Insulin Therapy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital for Children and Adolescents AUF DER BULT

Hanover, Lower Saxony, 30173, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Insulin pump Tandem: t:slim X2

Device

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.

Other names: Insulin pump Tandem: t:slim X2 with Control IQ

Primary outcomes

  1. Time in glucose range 70 - 180mg/dl (%)

    Time frame: 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 outcomes

  1. user satisfaction assessed by disabkids questionnaire for children and for parents

    Time frame: two weeks

    Comparison of both groups with regard to satisfaction via specific validated questionnaire at the start of the study

  2. user satisfaction assessed by disabkids questionnaire for children and for parents

    Time frame: 12 weeks

    Evaluation of the satisfaction of users via specific validated questionnare at the beginning and the end of study

  3. mean glucose level [mg/dl]

    Time frame: 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.

  4. mean glucose Level before study start [mg/dl]

    Time frame: two weeks

    Comparison of both groups concerning the mean glucose level of the two weeks before the start of the study.

  5. mean daily insulin amount

    Time frame: 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.

  6. mean daily insulin amount before study start

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kinderkrankenhaus auf der Bult

Other

Registry information

Official study title

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

Acronym: UNIQUE

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 12, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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