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

A Study Comparing Tandem Control-IQ With Real-time Continuous Glucose Monitoring (rtCGM) Used Together With Insulin Pens and Insulin Pumps for 18 Months

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Tandem Control-IQ

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.

• Study Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• Sweden
  • Region Of Halland
    • Kungsbacka, Region Of Halland, Sweden, 43480
      • The hospital of Halland Kungsbacka

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals diagnosed with Type 1 diabetes at two different pediatric diabetes centres.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
rtCGM + MDI; Real-time CGM Dexcom G6 used in parallel to Multiple Daily Injections (MDI)	Device: Tandem Control-IQ; AID-system
rtCGM + CSII; Real-time CGM Dexcom G6 used in parallel to freestanding Continuous Subcutaneous Insulin Infusion (CSII)	Device: Tandem Control-IQ; AID-system
Tandem Control-IQ; Realtime CGM Dexcom G6 used as part of the Automated Insulin Delivery (AID) system	Device: Tandem Control-IQ; AID-system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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.

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Investigators: Principal Investigator: Peter Adolfsson, MD PhD, Västra Götalandsregionen, Gothenburg University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: June 30, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: VastraGotaland - 2022-00332-01

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
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes