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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rtCGM + MDI | Real-time CGM Dexcom G6 used in parallel to Multiple Daily Injections (MDI) |
| |
| rtCGM + CSII | Real-time CGM Dexcom G6 used in parallel to freestanding Continuous Subcutaneous Insulin Infusion (CSII) |
| |
| Tandem Control-IQ | Realtime CGM Dexcom G6 used as part of the Automated Insulin Delivery (AID) system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tandem Control-IQ | Device | AID-system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic metrics | 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) | Change from baseline to 6, 12 and 18 months |
| Sleep | Quantity and quality are defined in the questionnaire. Assessment by a 10-point Likert scale (1= "Worst possible", 10= "Best possible") | At study completion at 12 months. |
| Costs - direct | Cost for the insulin administration devices and continuous glucose monitoring devices per person/year (direct). All costa are calculated in Swedish currency (SEK). | From baseline until study completion at 18 months |
| Costs - indirect | 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). | From baseline until study completion at 18 months |
| Quality Adjusted Life Year (QALY) | 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. | From baseline until study completion at 18 months. |
| Cost/QALY | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Glucose control at start of the study | 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. | At Baseline |
Inclusion Criteria:
Exclusion Criteria:
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Individuals diagnosed with Type 1 diabetes at two different pediatric diabetes centres.
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| Name | Affiliation | Role |
|---|---|---|
| Peter Adolfsson, MD PhD | Västra Götalandsregionen, Gothenburg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The hospital of Halland Kungsbacka | Kungsbacka | Region of Halland | 43480 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39239975 | Derived | Adolfsson P, Heringhaus A, Sjunnesson K, Mehkri L, Bolin K. Cost-effectiveness of the tandem t: Slim X2 with control-IQ technology automated insulin delivery system in children and adolescents with type 1 diabetes in Sweden. Diabet Med. 2024 Nov;41(11):e15432. doi: 10.1111/dme.15432. Epub 2024 Sep 6. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| From baseline until study completion at 18 months. |
| Incremental Cost Efficiency Rate (ICER) | 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. | From baseline until study completion at 18 months. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |