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

Observational 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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes; Insulin Therapy
• Intervention / Treatment: Device: Insulin pump Tandem: t:slim X2

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Germany
  • Lower Saxony
    • Hanover, Lower Saxony, Germany, 30173
      • Hospital for Children and Adolescents AUF DER BULT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 45 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Kinderkrankenhaus auf der Bult
• Investigators: Principal Investigator: Torben Biester, Dr., Hospital for Children and Adolescents AUF DER BULT

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 3, 2021
• Primary Completion (ACTUAL): December 28, 2021
• Study Completion (ACTUAL): December 28, 2021

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (ACTUAL): November 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: type 1 diabetes; closed loop; paediatrics; CSII (Continuous Subcutaneous Insulin Infusion)
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: Unique_1_2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No