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

NCT ID: NCT06586632

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2028-10-01

Brief 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.

Detailed Description

Type 1 diabetes is the result of an autoimmune destruction of the insulin-producing beta cells in the islets of Langerhans in the pancreas, leading to a vital need for insulin treatment. 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 sugar levels. The technology has been shown to result in significantly better diabetes control, measured by long-term blood sugar levels, hemoglobin A1c (HbA1c), and the time spent in the blood sugar target range (time in range (TIR)) compared to conventional insulin pen treatment. Additionally, the technology generally leads to an improvement in quality of life, manifested through better sleep, reduced anxiety, and fewer worries related to daily life with diabetes. Following these technological advances, a new survey on well-being and satisfaction among people with type 1 diabetes in Denmark has shown that over 85% of adults with diabetes are highly or very highly satisfied with their treatment. Despite this, diabetes distress remains present in 31% of individuals, particularly among young people, both with and without technology. Furthermore, we know that the initial period after a type 1 diabetes diagnosis can be marked by stress and challenges. In clinical practice, AID technology is predominantly used for individuals who have had diabetes for several years, and due to economic limitations in access to the treatment, it is especially used for those with treatment-related challenges in diabetes regulation, despite the fact that the treatment is approved and considered standard care. Through a systematic literature search for international studies, the investigators have not been able to locate studies examining the effect of AID technology for adults with newly diagnosed type 1 diabetes, making this study the first of its kind. With this study, the investigators hope to determine whether early treatment with AID technology can help individuals navigate the initial period after diagnosis more easily and to some extent free them from worries and stress related to diabetes, hence the name Steno Free. The aim of the study is to investigate whether AID technology combined with need-based 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 (PAID-20), improved quality of life (WHO-5), and increased health literacy (The Health Literacy Questionnaire);

2. better diabetes regulation (TIR and HbA1c);

3. less disease burden and, therefore, a greater degree of freedom in their daily lives (qualitative interviews).

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AID group

AID technology combined with on-demand consultations

Group Type: ACTIVE_COMPARATOR

AID technology

Intervention Type: DEVICE

Automated insulin delivery system combined with a CGM

CGM group

Standard care with insulin pen based therapy combined with CGM

Group Type: PLACEBO_COMPARATOR

CGM

Intervention Type: DEVICE

CGM alone

Interventions

AID technology

Automated insulin delivery system combined with a CGM

Intervention Type: DEVICE

CGM

CGM alone

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• new-onset of Type 1 diabetes with positive auto-antibodies

Exclusion Criteria

• negative auto-antibodies,
• uncertainty about the type 1 diabetes diagnosis
• pregnancy
• ongoing cancer or other acute/chronic severe illnesses that could potentially hinder participation and compliance in the project (determined by the PI)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liselotte Fisker, MD

Role: STUDY_DIRECTOR

Aarhus University Hospital

Central Contacts

Jakob Østergaard, MD, PhD

Role: CONTACT

jakooest@rm.dk

+4578450000

Other Identifiers

ID 2401691

Identifier Type: -

Identifier Source: org_study_id