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Digital Diabetes Self Management Education and Support for Patients With Type 2 Diabetes

Sponsor
Region Jönköping County (Other)
Overall Status
Recruiting
CT.gov ID
NCT05026528
Collaborator
Linkoeping University (Other), Region Östergötland (Other), Uppsala County Council, Sweden (Other), The Swedish Diabetes Foundation (Other), Medical Research Council of Southeast Sweden (Other)
300
Enrollment
2
Locations
2
Arms
60
Anticipated Duration (Months)
150
Patients Per Site
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to test the effect of using a digital diabetes self management education and support system compared with standard care for patients with type 2 diabetes in primary health care.

Condition or Disease Intervention/Treatment Phase
  • Other: Digital diabetes self management education and support system
 N/A

Detailed Description

After being informed verbally and in text participants will sign a consent to participate. The participant will then be randomized to either use a digital diabetes self management education and support system for 10 weeks together with a diabetes nurse, or to continue with the regular care. The effects will be evaluated after 6, 12 and 36 months from randomization with emphasis on cardiovascular risk factors, life-style, diabetes knowledge and health economics.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
The investigator performing measurements and collecting data as well as the outcomes assessor will be blinded to group allocation.
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Trial of a Digital Diabetes Self Management Education and Support System for Patients With Type 2 Diabetes in Primary Health Care
Actual Study Start Date :
Nov 30, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Digital DSME/S

Ten-week intervention during which the participant uses a digital diabetes self management education and support system together with the diabetes nurse.

Other: Digital diabetes self management education and support system
Digital diabetes self management and support system
Other Names:
  • Live well with type 2 diabetes

    		•
    No Intervention: Standard care

    Control group continuing with regular standardized care.

    Outcome Measures

    Primary Outcome Measures

    1. HbA1c [6 months]

      The level of glycated hemoglobin A1 in blood measured in mmol/mol.

    Other Outcome Measures

    1. Plasma cholesterol [6, 12 and 36 months]

      mmol/L

    2. Plasma LDL-cholesterol [6, 12 and 36 months]

      mmol/L

    3. Plasma HDL-cholesterol [6, 12 and 36 months]

      mmol/L

    4. Fasting plasma triglycerides [6, 12 and 36 months]

      mmol/L

    5. Fasting plasma glucose [6, 12 and 36 months]

      mmol/L

    6. Urinary albumin/creatinine ratio [6, 12 and 36 months]

      mg/mmol

    7. Waist circumference [6 and 12 months]

      cm

    8. Body mass index [6, 12 and 36 months]

      kg/m2

    9. Self reported physical activity level [6 and 12 months]

      International Physical Activity Questionnaire (IPAQ)

    10. Objectively measured physical activity level [6 and 12 months]

      Accelerometer Axivity AX3 will be used on a subgroup of 100 participants.

    11. Self reported dietary intake [6 and 12 months]

      Indicator questions from the Swedish National Board of Health and Welfare

    12. Health literacy [6 and 12 months]

      HLS-EU-Q16 questionnaire. 0-12 points. Higher score is better.

    13. Patient-reported outcome and experience measures [6 and 12 months]

      Questionnaire developed and validated by the National Swedish Diabetes Registry. 0-100 points for each of 8 PROM scales and 4 PREM scales. Higher score is better.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Type 2 diabetes mellitus diagnosed according to WHO criteria < 5 years from randomization:

    • Fasting plasma glucose > 7 mmol/L at two timepoints. OR

    • HbA1c ≥ 48 mmol/mol twice or in combination with fasting plasma glucose > 7 mmo/L once. OR

    • Non-fasting plasma glucose ≥ 11.1 mmol/L at one timepoint in combination with symptoms of hyperglycemia.

    • Access to a digital ID-card to access the digital system

    • Access to a computer, tablet or smart phone

    • Sufficient knowledge of written and spoken Swedish to understand the information given in the digital system.

    Exclusion Criteria:

    • Treatment with Insulin

    • Other co-morbidities limiting the use of the digital system according to the diabetes nurse judgement. E.g. dementia or severe psychiatric disease.

    • Other forms of diabetes mellitus than type 2 diabetes.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wetterhälsan Jönköping Sweden
    2 Aroma Vårdcentral Vetlanda Sweden

    Sponsors and Collaborators

    • Region Jönköping County
    • Linkoeping University
    • Region Östergötland
    • Uppsala County Council, Sweden
    • The Swedish Diabetes Foundation
    • Medical Research Council of Southeast Sweden

    Investigators

    • Principal Investigator: Andreas Stomby, MD/PhD, Region Jönköping County and Linköping University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Region Jönköping County
    ClinicalTrials.gov Identifier:
    NCT05026528
    Other Study ID Numbers:
    • Bra liv med diabetes typ 2
    First Posted:
    Aug 30, 2021
    Last Update Posted:
    Dec 15, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Region Jönköping County
    mHealth
    Primary health care
    Type 2 diabetes
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Dec 15, 2021