Clinical trial NCT06586632: The Steno Free Trial: AID to Adults with New-onset of Type 1 Diabetes
Official title: Automated Insulin Pumps and On-demand Consultations to Adults with New-onset of Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An exploratory, randomized, controlled, open-label, parallel design will be used to investigate 60 adult individuals with newly diagnosed type 1 diabetes. Randomization will occur in a 1:1 ratio to either the AID group (intervention group) or the CGM group (control group) using a digital randomization program.
Primary purpose: TREATMENT

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).

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)

Primary outcomes:
measure: Less diabetes distress
timeFrame: Paid-20 score will be assessed at baseline (inclusion), 3 months after inclusion and annually until end of study (anticipated average 24 months, but till the year 2028)
measure: Increased quality of life
timeFrame: Paid-20 score will be assessed at baseline (inclusion), 3 months after inclusion and annually until end of study(anticipated average 24 months, but till the year 2028)
measure: Increased health literacy
timeFrame: Paid-20 score will be assessed at baseline (inclusion), 3 months after inclusion and every 12 months until end of study(anticipated average 24 months, but till the year 2028)
Secondary outcomes:
measure: Glucose regulation 1
timeFrame: TIR will be measured at baseline (inclusion) and every 12 months until end of study (anticipated average 24 months, but till the year 2028)
measure: Glucose regulation 2
timeFrame: TAR will be measured at baseline (inclusion) and every 12 months until end of study (anticipated average 24 months, but till the year 2028)
measure: Glucose regulation 3
timeFrame: TBR will be measured at baseline (inclusion) and every 12 months until end of study (anticipated average 24 months, but till the year 2028)
measure: Glucose regulation 4
timeFrame: Estimated A1c will be measured at baseline (inclusion) and every 12 months until end of study(anticipated average 24 months, but till the year 2028)
measure: Insulin dosage
timeFrame: insulin dosage will be measured at baseline (inclusion) and every 12 months untill end of study(anticipated average 24 months, but till the year 2028)
measure: Number of hospitalizations
timeFrame: Will be measured retrospectively from start of study October 2024 until the end of the study(anticipated average 24 months, but till the year 2028)
measure: Consultations with the health care professionals
timeFrame: Data will be retrospectively collected at the end of the study (anticipated average 24 months, but till the year 2028)
measure: Sick days
timeFrame: Data will be retrospectively collected at the end of the study(anticipated average 24 months, but till the year 2028)
measure: Qualitative interviews
timeFrame: 3 months and 12 months after inclusion (anticipated average 24 months, but till the year 2028)
Other outcomes:
Locations:
Study officials:
affiliation: Aarhus University Hospital
name: Liselotte Fisker, MD
role: STUDY_DIRECTOR
References: