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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05026528
• Other study ID #: Bra liv med diabetes typ 2
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2021
• Est. completion date: December 2026

Study information

• Verified date: August 2021
• Source: Region Jönköping County
• Contact: Andreas Stomby, MD/PhD
• Phone: 0046739595129
• Email: andreas.stomby[@]rjl.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2026
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Digital diabetes self management education and support system
Digital diabetes self management and support system

Locations

Country	Name	City	State
Sweden	Wetterhälsan	Jönköping
Sweden	Aroma Vårdcentral	Vetlanda

Sponsors (6)

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

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma cholesterol	mmol/L	6, 12 and 36 months
Other	Plasma LDL-cholesterol	mmol/L	6, 12 and 36 months
Other	Plasma HDL-cholesterol	mmol/L	6, 12 and 36 months
Other	Fasting plasma triglycerides	mmol/L	6, 12 and 36 months
Other	Fasting plasma glucose	mmol/L	6, 12 and 36 months
Other	Urinary albumin/creatinine ratio	mg/mmol	6, 12 and 36 months
Other	Waist circumference	cm	6 and 12 months
Other	Body mass index	kg/m2	6, 12 and 36 months
Other	Self reported physical activity level	International Physical Activity Questionnaire (IPAQ)	6 and 12 months
Other	Objectively measured physical activity level	Accelerometer Axivity AX3 will be used on a subgroup of 100 participants.	6 and 12 months
Other	Self reported dietary intake	Indicator questions from the Swedish National Board of Health and Welfare	6 and 12 months
Other	Health literacy	HLS-EU-Q16 questionnaire. 0-12 points. Higher score is better.	6 and 12 months
Other	Patient-reported outcome and experience measures	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.	6 and 12 months
Primary	HbA1c	The level of glycated hemoglobin A1 in blood measured in mmol/mol.	6 months