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

R

Region Jönköping County

Status

Terminated

Conditions

Type 2 Diabetes

Treatments

Other: Digital diabetes self management education and support system

Study type

Interventional

Funder types

Other

Identifiers

NCT05026528
Bra liv med diabetes typ 2

Details and patient eligibility

About

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.

Full 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.

Enrollment

138 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

138 participants in 2 patient groups

Digital DSME/S
Experimental group
Description:
Ten-week intervention during which the participant uses a digital diabetes self management education and support system together with the diabetes nurse.
Treatment:
Other: Digital diabetes self management education and support system
Standard care
No Intervention group
Description:
Control group continuing with regular standardized care.

Trial contacts and locations

15

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Central trial contact

Frida Jarl, MD; Andreas Stomby, MD/PhD

Data sourced from clinicaltrials.gov

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