NCT06586632Not yet recruiting
The Steno Free Trial: AID to Adults with New-onset of Type 1 Diabetes
Automated Insulin Pumps and On-demand Consultations to Adults with New-onset of Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 22 Aug 2024
- Start date
- 1 Oct 2024
- Primary completion date
- 1 Oct 2028
- Lead sponsor
- University of Aarhus
- Diseases
- Type 1 diabetes
- NCT number
- NCT06586632
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Oct 2024 to the primary completion date, 1 Oct 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- negative auto-antibodies,
Other illness
- uncertainty about the type 1 diabetes diagnosis
- ongoing cancer or other acute/chronic severe illnesses that could potentially hinder participation and compliance in the project (determined by the PI)
Other
- pregnancy
Who the study is looking for
- new-onset of Type 1 diabetes with positive auto-antibodies
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.