Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586632
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
The Steno Free Trial AID to Adults with New-onset of Type 1 Diabetes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Automated Insulin Pumps and On-demand Consultations to Adults with New-onset of Type 1 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None