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

NCT06586632 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

AID technology

Automated insulin delivery system combined with a CGM

DEVICE

CGM

CGM alone

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Liselotte Fisker, MD · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2028-10-01
Completion
2028-10-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06586632 on ClinicalTrials.gov