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

Vastra Gotaland Region

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Device: Tandem Control-IQ

Study type: Observational

Funder types: Other

Identifiers

NCT05969106

VastraGotaland - 2022-00332-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 2 to 19 years old

Volunteers: No Healthy Volunteers

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)

Trial design

84 participants in 3 patient groups

rtCGM + MDI

Description:

Real-time CGM Dexcom G6 used in parallel to Multiple Daily Injections (MDI)

Treatment:

Device: Tandem Control-IQ

rtCGM + CSII

Description:

Real-time CGM Dexcom G6 used in parallel to freestanding Continuous Subcutaneous Insulin Infusion (CSII)

Treatment:

Device: Tandem Control-IQ

Tandem Control-IQ

Description:

Realtime CGM Dexcom G6 used as part of the Automated Insulin Delivery (AID) system

Treatment:

Device: Tandem Control-IQ