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Randomized Controlled Trial of Digital Diabetes Self Management Education and Support for Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT05026528
Recruitment Status : Not yet recruiting
First Posted : August 30, 2021
Last Update Posted : August 30, 2021
Sponsor:
Collaborators:
Linkoeping University
Region Östergötland
Uppsala County Council, Sweden
The Swedish Diabetes Foundation
Medical Research Council of Southeast Sweden
Information provided by (Responsible Party):
Region Jönköping County

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
Type 2 Diabetes Other: Digital diabetes self management education and support system Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


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 Name: Live well with type 2 diabetes

No Intervention: Standard care
Control group continuing with regular standardized care.



Primary Outcome Measures :
  1. HbA1c [ Time Frame: 6 months ]
    The level of glycated hemoglobin A1 in blood measured in mmol/mol.


Other Outcome Measures:
  1. Plasma cholesterol [ Time Frame: 6, 12 and 36 months ]
    mmol/L

  2. Plasma LDL-cholesterol [ Time Frame: 6, 12 and 36 months ]
    mmol/L

  3. Plasma HDL-cholesterol [ Time Frame: 6, 12 and 36 months ]
    mmol/L

  4. Fasting plasma triglycerides [ Time Frame: 6, 12 and 36 months ]
    mmol/L

  5. Fasting plasma glucose [ Time Frame: 6, 12 and 36 months ]
    mmol/L

  6. Urinary albumin/creatinine ratio [ Time Frame: 6, 12 and 36 months ]
    mg/mmol

  7. Waist circumference [ Time Frame: 6 and 12 months ]
    cm

  8. Body mass index [ Time Frame: 6, 12 and 36 months ]
    kg/m2

  9. Self reported physical activity level [ Time Frame: 6 and 12 months ]
    International Physical Activity Questionnaire (IPAQ)

  10. Objectively measured physical activity level [ Time Frame: 6 and 12 months ]
    Accelerometer Axivity AX3 will be used on a subgroup of 100 participants.

  11. Self reported dietary intake [ Time Frame: 6 and 12 months ]
    Indicator questions from the Swedish National Board of Health and Welfare

  12. Health literacy [ Time Frame: 6 and 12 months ]
    HLS-EU-Q16 questionnaire

  13. Patient-reported outcome and experience measures [ Time Frame: 6 and 12 months ]
    Questionnaire developed and validated by the National Swedish Diabetes Registry



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT05026528


Contacts
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Contact: Andreas Stomby, MD/PhD 0046739595129 andreas.stomby@rjl.se
Contact: Frida Jarl, MD frida.jarl@rjl.se

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
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Principal Investigator: Andreas Stomby, MD/PhD Region Jönköping County and Linköping University
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Responsible Party: Region Jönköping County
ClinicalTrials.gov Identifier: NCT05026528    
Other Study ID Numbers: Bra liv med diabetes typ 2
First Posted: August 30, 2021    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Since it is unclear to what extent this form of personal information can be transferred abroad according to Swedish law, both within and outside the European Union we do not plan to share individual patient data at the moment.

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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:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases