My Type 2 Diabetes: Person-centred Health Care
MinT2D
1 other identifier
interventional
110
1 country
1
Brief Summary
The Type 2 diabetes (T2D) project is a research and innovation project that will create a new comprehensive, participant-centered service model for interaction, increased physical activity, self-management, distance monitoring and lifestyle change for patients with type 2 diabetes. Central to the degree of innovation is a new model for interaction and use of technology for distance monitoring and coping.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started Aug 2020
Typical duration for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 17, 2020
CompletedFirst Submitted
Initial submission to the registry
October 22, 2020
CompletedFirst Posted
Study publicly available on registry
June 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedJune 5, 2024
June 1, 2024
1.4 years
October 22, 2020
June 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Glycated haemoglobin (HbA1c) from baseline until week 12
Glycated haemoglobin (HbA1c) is a measurement of the three-month average blood sugar level and HbA1c is an important outcome measure in diabetes clinical trials.
Baseline and week 12
Secondary Outcomes (4)
Change in waist circumference from baseline until week 12
Baseline and week 12
Change in physical fitness by the number of personalized activity index (PAI) from baseline until week 12
Baseline and week 12
Health competence
Baseline and week 12
Change in mental health by questionnaire Symptom Checklist-90-R (SCL-90-R) until week 12
Baseline and week 12
Study Arms (2)
Intervention
ACTIVE COMPARATORBaseline testing with blood samples, blood pressure and 6 minute walking test. After answering a comprehensive screening tool questionnaire and a conversation with a resource person about "What is important to you", the study participant will chose one or several of the following interventions: physical activity, nutrition, motivation, health competence, psychosocial.
Control
NO INTERVENTIONBaseline testing with blood samples, blood pressure, 6 minute walking test and screening tool questionnaire.
Interventions
physical activity, nutrition, motivation, health competence, psychosocial.
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
You may not qualify if:
- Unstable cardiovascular disease
- Severe chronic obstructive pulmonary disease (COPD)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian University of Science and Technologylead
- The Centre for Health Innovationcollaborator
- The Dam Foundationcollaborator
Study Sites (1)
Department of Circulation and Medical Imaging, NTNU
Trondheim, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charlotte Ingul, PhD
Norwegian University of Science and Technology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2020
First Posted
June 23, 2021
Study Start
August 17, 2020
Primary Completion
December 31, 2021
Study Completion
December 31, 2022
Last Updated
June 5, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share