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Completed

NCT Number: NCT05969106

Tandem Control-IQ Evaluation Regarding Glucose Metrics, Sleep, and Health Economics

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.

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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 Metabolic Diseases Nutritional and Metabolic Diseases

Age range

2 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The hospital of Halland Kungsbacka

Kungsbacka, Region of Halland, 43480, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Tandem Control-IQ

Device

AID-system

Primary outcomes

  1. Glycemic metrics

    Time frame: Change from baseline to 6, 12 and 18 months

    Time in range (TIR), Time below range (TBR) Level 1 and 2, Time above range (TAR) Level 1 and 2, Time in tighter range (TITR)

  2. Sleep

    Time frame: At study completion at 12 months.

    Quantity and quality are defined in the questionnaire. Assessment by a 10-point Likert scale (1= "Worst possible", 10= "Best possible")

  3. Costs - direct

    Time frame: From baseline until study completion at 18 months

    Cost for the insulin administration devices and continuous glucose monitoring devices per person/year (direct). All costa are calculated in Swedish currency (SEK).

  4. Costs - indirect

    Time frame: From baseline until study completion at 18 months

    Cost for comorbidities and all health-care related costs (indirect), including societal costs based on days with sick-leaves (indirect). All costs are calculated in Swedish currency (SEK).

  5. Quality Adjusted Life Year (QALY)

    Time frame: From baseline until study completion at 18 months.

    Quality Adjusted Life Year is estimated for each health state by literature search and for each of the three treatment alternatives. QALY is a generic measure of disease burden, including both the quality and the quantity of life lived. It is used in economic evaluation to assess the value of medical interventions. One QALY equates to one year in perfect health. QALY scores range from 1 (perfect health) to 0 (dead). Thus, a higher value means a better outcome.

  6. Cost/QALY

    Time frame: From baseline until study completion at 18 months.

    Cost/QALY is estimated for each health state by literature search and for each of the three treatment alternatives. Cost/QALY is illustrating the cost per disease burden, including both the quality and the quantity of life lived. It is used in economic evaluation to assess the cost per value of medical interventions. A lower value means a better outcome.

  7. Incremental Cost Efficiency Rate (ICER)

    Time frame: From baseline until study completion at 18 months.

    Based on glucose control cost-effect pairs is generated for Tandem Control-IQ vs. MDI respectively Tandem-Control-IQ vs. CSII. An ICER is calculated by dividing the difference in total costs (incremental cost) by the difference in the chosen measure of health outcome or effect (incremental effect) to provide a ratio of 'extra cost per extra unit of health effect' - for therapy A vs therapy B. A higher value means a better outcome. A prediction is added 10-, 20-, and 30-years ahead. ICER is estimated for these three time intervals.

Other outcomes

  1. Glucose control at start of the study

    Time frame: At Baseline

    In all participants, Hemoglobin A1c (HbA1c) is measured before the start of the study and comparisons are made between the three treatment groups regarding mean HbA1c and how dispersed the data is in relation to the mean (standard deviation). A lower HbA1c means a better glucose control and a lower standard deviation means less variability within the group.

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study 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

Acronym: STARCARE

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 1, 2023
Registry last updated
Aug 1, 2023

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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