Clinical trial NCT05679115: Evaluation of Lifestyle Tool in Type 2 Diabetes
Official title: Randomized Evaluation of the Lifestyle Tool in Individuals With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 200
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall aim of the study is to observe the change of long-term metabolic control in patients with type 2 diabetes who have access to a digital intervention tool as compared with randomized controls during one year. The tool is based on self-affirmation theory and has large emphasis on self-reflection to enable sustainable lifestyle changes. .

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes at or above 35 years of age
* HbA1C at 52 mmol/mol or above
* Diagnosis of diabetes mellitus was based on prior documentation or treatment with anti-hyperglycemic medication
* written informed consent.

Exclusion Criteria:

* type 1 diabetes, MODY or secondary diabetes
* conditions or treatments that in the judgement of the Investigator could affect the study evaluation
* connection with the study team, funders, authorities, universities or other public or private bodies in such a way that specific interests in the study outcomes could be suspected.

Primary outcomes:
measure: Change of long-term blood glucose concentration measured as glycated hemoglobin at 1 year
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Clinical Research Center
Study officials:
affiliation: Region Skåne
name: Anders Rosengren, Professor
role: PRINCIPAL_INVESTIGATOR
References: