Back to resultsDigital Diabetes Self Management Education and Support for Patients With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Digital diabetes self management education and support system
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring mHealth, Primary health care, Type 2 diabetes
Eligibility 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.
Sites / Locations
- WetterhälsanRecruiting
- Aroma VårdcentralRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Digital DSME/S
Standard care
Arm Description
Ten-week intervention during which the participant uses a digital diabetes self management education and support system together with the diabetes nurse.
Control group continuing with regular standardized care.
Outcomes
Primary Outcome Measures
HbA1c
The level of glycated hemoglobin A1 in blood measured in mmol/mol.
Secondary Outcome Measures
Full Information
NCT ID
NCT05026528
First Posted
August 24, 2021
Last Updated
November 30, 2021
Sponsor
Region Jönköping County
Collaborators
Linkoeping University, Region Östergötland, Uppsala County Council, Sweden, The Swedish Diabetes Foundation, Medical Research Council of Southeast Sweden
1. Study Identification
Unique Protocol Identification Number
NCT05026528
Brief Title
Digital Diabetes Self Management Education and Support for Patients With Type 2 Diabetes
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Jönköping County
Collaborators
Linkoeping University, Region Östergötland, Uppsala County Council, Sweden, The Swedish Diabetes Foundation, Medical Research Council of Southeast Sweden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
mHealth, Primary health care, Type 2 diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
The investigator performing measurements and collecting data as well as the outcomes assessor will be blinded to group allocation.
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Digital DSME/S
Arm Type
Experimental
Arm Description
Ten-week intervention during which the participant uses a digital diabetes self management education and support system together with the diabetes nurse.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Control group continuing with regular standardized care.
Intervention Type
Other
Intervention Name(s)
Digital diabetes self management education and support system
Other Intervention Name(s)
Live well with type 2 diabetes
Intervention Description
Digital diabetes self management and support system
Primary Outcome Measure Information:
Title
HbA1c
Description
The level of glycated hemoglobin A1 in blood measured in mmol/mol.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Plasma cholesterol
Description
mmol/L
Time Frame
6, 12 and 36 months
Title
Plasma LDL-cholesterol
Description
mmol/L
Time Frame
6, 12 and 36 months
Title
Plasma HDL-cholesterol
Description
mmol/L
Time Frame
6, 12 and 36 months
Title
Fasting plasma triglycerides
Description
mmol/L
Time Frame
6, 12 and 36 months
Title
Fasting plasma glucose
Description
mmol/L
Time Frame
6, 12 and 36 months
Title
Urinary albumin/creatinine ratio
Description
mg/mmol
Time Frame
6, 12 and 36 months
Title
Waist circumference
Description
cm
Time Frame
6 and 12 months
Title
Body mass index
Description
kg/m2
Time Frame
6, 12 and 36 months
Title
Self reported physical activity level
Description
International Physical Activity Questionnaire (IPAQ)
Time Frame
6 and 12 months
Title
Objectively measured physical activity level
Description
Accelerometer Axivity AX3 will be used on a subgroup of 100 participants.
Time Frame
6 and 12 months
Title
Self reported dietary intake
Description
Indicator questions from the Swedish National Board of Health and Welfare
Time Frame
6 and 12 months
Title
Health literacy
Description
HLS-EU-Q16 questionnaire. 0-12 points. Higher score is better.
Time Frame
6 and 12 months
Title
Patient-reported outcome and experience measures
Description
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.
Time Frame
6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Stomby, MD/PhD
Phone
0046739595129
Email
andreas.stomby@rjl.se
First Name & Middle Initial & Last Name or Official Title & Degree
Frida Jarl, MD
Email
frida.jarl@rjl.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Stomby, MD/PhD
Organizational Affiliation
Region Jönköping County and Linköping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wetterhälsan
City
Jönköping
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders Tengblad, PhD
Email
anders.tengblad@rjl.se
Facility Name
Aroma Vårdcentral
City
Vetlanda
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johanna Richter
Email
johanna.richter@rjl.se
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data will be available upon request to the principal investigator (Andreas Stomby) if it is in accordance with Swedish and international law. Thus, all requests will be judged before IPD is eventually shared.
IPD Sharing Time Frame
Data will be available after the research group has conducted the planned analyses. Preliminary in year 2025.
IPD Sharing Access Criteria
See above
Learn more about this trial
Digital Diabetes Self Management Education and Support for Patients With Type 2 Diabetes
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