Clinical trial NCT05969106: Tandem Control-IQ Evaluation Regarding Glucose Metrics, Sleep, and Health Economics
Official title: A Study Comparing Tandem Control-IQ With Real-time Continuous Glucose Monitoring (rtCGM) Used Together With Insulin Pens and Insulin Pumps for 18 Months
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2023-08-01
Enrollment: 84
Sex: ALL
Minimum age (years): 2
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals diagnosed with Type 1 diabetes at two different pediatric diabetes centres.

Brief summary: To evaluate Tandem Control-IQ compared with rtCGM and insulin pen respectively rtCGM and insulin pump treatment in children and adolescents regarding glucose control, sleep and health economics for 18 months.

Detailed description: In this obesrvational study, the investigators assessed glycemic outcomes, sleep and health economics associated with AID treatment (Tandem Control-IQ) compared with multiple daily insulin injections with rtCGM (MDI+rtCGM) and a standalone insulin pump with rtCGM (CSII+rtCGM). Participants from two clinical sites in Sweden who continuously used one of the three modalities for at least six months were included in the analysis. Inclusion required all participants to use the Dexcom G6 rtCGM sensor for glucose monitoring, which meant only insulin treatment differentiated the three groups. Comparisons were conducted regarding Hemoglobon A1c (HbA1c) at the start of the study and rtCGM-generated glycemic metrics from 1 month before the study started until 18 months. Sleep quality and quantity were assessed using a questionnaire for the persons with diabetes and the caretakers. Indirect and direct costs in all healthcare systems and additional information on sick leaves were collected from the Swedish Social Insurance Agency. Comparisons were then made between the three treatment alternatives.

Eligibility criteria: Inclusion Criteria:

* Age between 2-19 years at the start
* Diagnosed with Type 1 diabetes
* Min duration three months
* Willingness to participate in the study

Exclusion Criteria:

* Pregnancy
* Unwillingness to share and upload CGM data
* Reluctance to come to visit and to follow protocol
* History of allergic reaction to Dexcom CGM materials or adhesives in contact with the skin.
* Abnormal skin at the anticipated glucose sensor attachment sites(excessive hair, burn, inflammation, infection, rash, and/or tattoo)

Primary outcomes:
measure: Glycemic metrics
timeFrame: Change from baseline to 6, 12 and 18 months
measure: Sleep
timeFrame: At study completion at 12 months.
measure: Costs - direct
timeFrame: From baseline until study completion at 18 months
measure: Costs - indirect
timeFrame: From baseline until study completion at 18 months
measure: Quality Adjusted Life Year (QALY)
timeFrame: From baseline until study completion at 18 months.
measure: Cost/QALY
timeFrame: From baseline until study completion at 18 months.
measure: Incremental Cost Efficiency Rate (ICER)
timeFrame: From baseline until study completion at 18 months.
Secondary outcomes:
Other outcomes:
measure: Glucose control at start of the study
timeFrame: At Baseline
Locations:
city: Kungsbacka
country: Sweden
facility: The hospital of Halland Kungsbacka
state: Region Of Halland
Study officials:
affiliation: Västra Götalandsregionen, Gothenburg University
name: Peter Adolfsson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: