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

Randomized Controlled Trial of a Digital Diabetes Self Management Education and Support System for Patients With Type 2 Diabetes in Primary Health Care

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Digital diabetes self management education and support system

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andreas Stomby, MD/PhD; Phone Number: 0046739595129; Email: andreas.stomby@rjl.se
• Study Contact Backup: Name: Frida Jarl, MD; Email: frida.jarl@rjl.se

Study Locations

• Sweden
  • Jönköping, Sweden
    • Recruiting
    • Wetterhälsan
    • Contact: Anders Tengblad, PhD; Email: anders.tengblad@rjl.se
  • Vetlanda, Sweden
    • Recruiting
    • Aroma Vårdcentral
    • Contact: Johanna Richter; Email: johanna.richter@rjl.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	The level of glycated hemoglobin A1 in blood measured in mmol/mol.	6 months

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Region Jönköping County
• Collaborators: Linkoeping University; Region Östergötland; Uppsala County Council, Sweden; Medical Research Council of Southeast Sweden; The Swedish Diabetes Foundation
• Investigators: Principal Investigator: Andreas Stomby, MD/PhD, Region Jönköping County and Linköping University

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: August 24, 2021
• First Submitted That Met QC Criteria: August 24, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): December 15, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Type 2 diabetes; Primary health care; mHealth
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Bra liv med diabetes typ 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No