Type 1 DiabetesNCT06586632
The Steno Free Trial: AID to Adults with New-onset of Type 1 Diabetes
A study testing AID technology and CGM in people with Type 1 Diabetes, run by University of Aarhus.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- AID technology and CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- new-onset of Type 1 diabetes with positive auto-antibodies
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Automated Insulin Pumps and On-demand Consultations to Adults with New-onset of Type 1 Diabetes
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:
- less diabetes distress, improved quality of life, and increased health literacy,
- better diabetes regulation,
- less disease burden and, therefore, a greater degree of freedom in their daily lives.
Read the 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:
- less diabetes distress (PAID-20), improved quality of life (WHO-5), and increased health literacy (The Health Literacy Questionnaire);
- better diabetes regulation (TIR and HbA1c);
- less disease burden and, therefore, a greater degree of freedom in their daily lives (qualitative interviews).
- Conditions
- Type 1 Diabetes
- Being tested
- AID technology, CGM
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AID technologyDevice
Automated insulin delivery system combined with a CGM
CGMDevice
CGM alone
| Study group | Role | What they receive |
|---|---|---|
| AID group | Active comparator | AID technology combined with on-demand consultations Receives: Device: AID technology |
| CGM group | Placebo comparator | Standard care with insulin pen based therapy combined with CGM Receives: Device: CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
CGM data including Time In Range (TIR) for the last 14 days measured by a dexcom sensor
Measured: 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
CGM data including Time above range (TAR) for the last 14 days measured by a dexcom sensor
Measured: 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
CGM data including Time below range (TBR) for the last 14 days measured by a dexcom sensor
Measured: 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
CGM data including estimated haemoglobin A1C via a dexcom sensor
Measured: 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 from both groups
Measured: 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)
Number of hospitalizations
number of hospitalizations due to hypoglycemia or diabetic ketoacidosis
Measured: 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)
Consultations with the health care professionals
amount of physical or virtual consultations
Measured: Data will be retrospectively collected at the end of the study (anticipated average 24 months, but till the year 2028)
Sick days
participants will be asked at the regularly visit at the hospital the amount of sick days since last consultation
Measured: Data will be retrospectively collected at the end of the study(anticipated average 24 months, but till the year 2028)
Qualitative interviews
Qualitative interviews with emphasis on their own experience participating in the study
Measured: 3 months and 12 months after inclusion (anticipated average 24 months, but till the year 2028)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Liselotte Fisker, MD, Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586632
- Sponsor's protocol ID
- ID 2401691
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data will be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Insulin Pumps and On-demand Consultations to Adults with New-onset of Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06586632
- Acronym / sponsor ID
- ID 2401691
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- less diabetes distress, improved quality of life, and increased health literacy,
- better diabetes regulation,
- 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:
- less diabetes distress (PAID-20), improved quality of life (WHO-5), and increased health literacy (The Health Literacy Questionnaire);
- better diabetes regulation (TIR and HbA1c);
- less disease burden and, therefore, a greater degree of freedom in their daily lives (qualitative interviews).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| AID group | Active comparator | Device: AID technologyAID technology combined with on-demand consultations |
| CGM group | Placebo comparator | Device: CGMStandard care with insulin pen based therapy combined with CGM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- new-onset of Type 1 diabetes with positive auto-antibodies
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AID technologyAutomated insulin delivery system combined with a CGM | Device | AID group |
| CGMCGM alone | Device | CGM group |
Primary outcome
Less diabetes distress
Time frame: 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)
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.
Increased quality of life
Time frame: 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 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.
Increased health literacy
Time frame: 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)
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.
9 secondary outcomes
Glucose regulation 1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Number of hospitalizations
Time frame: 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)
Consultations with the health care professionals
Time frame: Data will be retrospectively collected at the end of the study (anticipated average 24 months, but till the year 2028)
Sick days
Time frame: Data will be retrospectively collected at the end of the study(anticipated average 24 months, but till the year 2028)
Qualitative interviews
Time frame: 3 months and 12 months after inclusion (anticipated average 24 months, but till the year 2028)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. data will be shared upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liselotte Fisker, MD study director
Aarhus University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing AID technology and CGM in people with Type 1 Diabetes, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jakob Østergaard, MD, PhD (+4578450000, jakooest@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Less diabetes distress (time frame: 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.