Evaluation of Lifestyle Tool in Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT05679115|
Recruitment Status : Recruiting
First Posted : January 10, 2023
Last Update Posted : January 26, 2023
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Behavioral: Lifestyle tool||Not Applicable|
Type-2 diabetes afflicts more than 300 million people worldwide and poses a heavy burden on the healthcare systems everywhere. Recent guidelines from the American Diabetes Association and the European Association for the Study of Diabetes recommend enhanced focus on lifestyle management in addition to glucose-lowering drugs. Individual or group-based diabetes education programs can improve glucose control and quality-of-life, but they are resource-intense and long-term outcomes are variable. Moreover, less than one out of ten individuals with diabetes attend such programs because of practical, medical and financial hurdles to attend sessions.
Consequently, there is a large need for complementary lifestyle support that can meet individual preferences in content and timing and reach many patients at low cost. Digital tools have considerable potential for clinical utility, but there are several important knowledge gaps. First, data on long-term efficacy (>6 months) are scarce. Second, they are often combined with coaching or intensified healthcare contacts, making it difficult to specifically assess the effect of the digital component and apply the results to a broad range of settings with variations in structure and resources. Third, it is unclear how they affect concrete behaviours such as physical activity and physiological measures of insulin resistance and insulin secretion.
The investigators have developed a self-managed lifestyle tool that is based on a new approach combining health information with structured self-reflection to effectively promote behavioural change. The tool is digital, does not require additional healthcare resources and could be used for large numbers of patients in a scalable manner.
Study participants with type 2 diabetes will now be randomized to access the tool and the change of long-term blood glucose from baseline to end of follow-up will be compared with participants who are randomized to a control group without access to the tool.
Participants attend study visits every three months for blood sampling. Study personnel are instructed to remain neutral at blood sampling visits and not reinforce usage in order to assess the frequency of use and resultant outcomes that can be expected in real-life situations over extended time without the need for increased healthcare support. Technical problems are referred to a study coordinator, who also responded to requests to clarify content in a general manner without providing personal advice.
Study participants are managed by their ordinary healthcare providers throughout the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Evaluation of the Lifestyle Tool in Individuals With Type 2 Diabetes|
|Actual Study Start Date :||January 10, 2023|
|Estimated Primary Completion Date :||March 1, 2024|
|Estimated Study Completion Date :||June 1, 2024|
Experimental: Lifestyle intervention
Participants get access to the tool and use it regularly
Behavioral: Lifestyle tool
Regular use of the digital Lifestyle tool
No Intervention: Controls on standard care
Participants who get randomized to control cannot access the tool.
- Change of long-term blood glucose concentration measured as glycated hemoglobin at 1 year [ Time Frame: 1 year ]Intraindividual change of long-term blood glucose concentration measured as glycated hemoglobin (HbA1c) at 1 year relative to baseline compared between participants with access to the tool and on usual care.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05679115
|Contact: Birgitta Abrahamssonfirstname.lastname@example.org|
|Clinical Research Center||Recruiting|
|Malmö, Sweden, 20502|
|Contact: Anders Rosengren, prof 0705316704 email@example.com|
|Principal Investigator: Anders Rosengren, MD PhD Prof|
|Principal Investigator:||Anders Rosengren, Professor||Region Skåne|