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Evaluation of Lifestyle Tool in Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05679115
Recruitment Status : Recruiting
First Posted : January 10, 2023
Last Update Posted : January 26, 2023
Sponsor:
Information provided by (Responsible Party):
Region Skane

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. .

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Lifestyle tool Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Birgitta Abrahamsson 0705316704 birgitta.x.abrahamsson@skane.se

Locations
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Sweden
Clinical Research Center Recruiting
Malmö, Sweden, 20502
Contact: Anders Rosengren, prof    0705316704    anders.rosengren@gu.se   
Principal Investigator: Anders Rosengren, MD PhD Prof         
Sponsors and Collaborators
Region Skane
Investigators
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Principal Investigator: Anders Rosengren, Professor Region Skåne
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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT05679115    
Other Study ID Numbers: HealthDiabetes2
First Posted: January 10, 2023    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results will be shared after deidentification.
Time Frame: Data will be available after publication.
Access Criteria: To researchers who provide a methodologically sound proposal in order to achieve the aims of that proposal. Proposals should be directed by email to livsstilsverktyget@gu.se

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases