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

NCT05118945 | Completed

• 1 other identifier: Unique_1_2021
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Insulin Therapy

Keywords

paediatrics; type 1 diabetes; closed loop; CSII (Continuous Subcutaneous Insulin Infusion)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• user satisfaction assessed by disabkids questionnaire for children and for parents

  two weeks

• user satisfaction assessed by disabkids questionnaire for children and for parents

  12 weeks

• mean glucose level [mg/dl]

  two weeks

• mean glucose Level before study start [mg/dl]

  two weeks

• mean daily insulin amount

  12 weeks

Study Arms (2)

SWITCH group: Change from Basal IQ to Control IQ

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.

Device: Insulin pump Tandem: t:slim X2

START group: Change from conservative therapy to Control IQ

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.

Device: Insulin pump Tandem: t:slim X2

Interventions

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.

Also known as: Insulin pump Tandem: t:slim X2 with Control IQ

START group: Change from conservative therapy to Control IQ; SWITCH group: Change from Basal IQ to Control IQ

Eligibility Criteria

• Age: 6 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Refusal of participation by the participant or a parent

Sponsors & Collaborators

• Kinderkrankenhaus auf der Bult: lead

Study Sites (1)

Hospital for Children and Adolescents AUF DER BULT

Hanover, Lower Saxony, 30173, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Torben Biester, Dr.

  Hospital for Children and Adolescents AUF DER BULT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: November 12, 2021
• Study Start: March 3, 2021
• Primary Completion: December 28, 2021
• Study Completion: December 28, 2021
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)