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NOT YET RECRUITING
NCT06586632
NA

The Steno Free Trial: AID to Adults with New-onset of Type 1 Diabetes

Sponsor: University of Aarhus

View on ClinicalTrials.gov

Summary

Since the introduction of insulin therapy 100 years ago, significant progress has continuously been made in the treatment of people with type 1 diabetes. In the last 10 years, the focus has largely been on technology, and the introduction of automated insulin delivery (AID) systems has revolutionized the treatment of type 1 diabetes. AID is an automated system that works by enabling the insulin pump and continuous glucose monitor (CGM) to communicate with each other, automatically adjusting the subcutaneous insulin dosage according to blood glucose levels. AID technology is predominantly used for individuals with long duration of type 1 diabetes, and due to economic limitations in access to the treatment, it is especially used for those with treatment-related challenges in diabetes regulation. The aim of the Steno Free trials is to investigate whether AID technology combined with on-demand consultations for adults with newly diagnosed type 1 diabetes, compared to conventional standard treatment with a CGM after 1 year of treatment, leads to: 1. less diabetes distress, improved quality of life, and increased health literacy, 2. better diabetes regulation, 3. less disease burden and, therefore, a greater degree of freedom in their daily lives.

Official title: Automated Insulin Pumps and On-demand Consultations to Adults with New-onset of Type 1 Diabetes

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-10-01

Completion Date

2028-10-01

Last Updated

2024-09-19

Healthy Volunteers

No

Conditions

Interventions

DEVICE

AID technology

Automated insulin delivery system combined with a CGM

DEVICE

CGM

CGM alone