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

NCT06586632 | Not Yet Recruiting

• 1 other identifier: ID 2401691
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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. 1.less diabetes distress, improved quality of life, and increased health literacy,
2. 2.better diabetes regulation,
3. 3.less disease burden and, therefore, a greater degree of freedom in their daily lives.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (3)

• Less diabetes distress

  Less diabetes distress will be measured via the Problem Areas in Diabetes scale (Paid-20) questionnaire.The Problem Areas In Diabetes (PAID) scale is a well- validated, psychometrically robust questionnaire with 20 items.The PAID is a self-report pencil and paper questionnaire that contains 20 items. The higher score the more negative emotions related to diabetes.

  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)

• Increased quality of life

  Increased quality of life will be measured via the Well-being index (WHO-5) questionnaire. The higher score the more quality of life. (The WHO-5 is focused on subjective quality of life based on positive mood (good spirits, relaxation), vitality (being active and waking up fresh and rested), and general interest (being interested in things). A score below 50 can indicate poor well-being which may be secondary to a depressive disorder or other etiology and is an indication for further evaluation.

  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)

• Increased health literacy

  Increased health literacy will be measured via the Health Literacy questionnaire (HLQ).The HLQ has nine scales that each measure an aspect of the multidimensional construct of health literacy. All scales have good psychometric properties. The higher score the more health literacy.

  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 (9)

• Glucose regulation 1

  TIR will be measured at baseline (inclusion) and every 12 months until end of study (anticipated average 24 months, but till the year 2028)

• Glucose regulation 2

  TAR will be measured at baseline (inclusion) and every 12 months until end of study (anticipated average 24 months, but till the year 2028)

• Glucose regulation 3

  TBR will be measured at baseline (inclusion) and every 12 months until end of study (anticipated average 24 months, but till the year 2028)

• Glucose regulation 4

  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)

• Insulin dosage

  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)

Study Arms (2)

AID group

ACTIVE COMPARATOR

AID technology combined with on-demand consultations

Device: AID technology

CGM group

PLACEBO COMPARATOR

Standard care with insulin pen based therapy combined with CGM

Device: CGM

Interventions

AID technology DEVICE

Automated insulin delivery system combined with a CGM

AID group

CGM DEVICE

CGM alone

CGM group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Liselotte Fisker, MD

  Aarhus University Hospital

  STUDY DIRECTOR

Central Study Contacts

Jakob Østergaard, MD, PhD

CONTACT

+4578450000; jakooest@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after study end (October 2028)
• Access Criteria: Upon request to the first author they will be given acces to individual data captured at baseline and during the study period