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Towards a Better Understanding of Diabetes Distress, Depression and Poor Glycaemic Control in T2DM

NCT04438018 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 205

Last updated 2022-04-08

No results posted yet for this study

Summary

DIA-LINK2 is a prospective observational study analysing longitudinal associations and mediating links between diabetes distress (DD), depressive symptoms (DS) and glycaemic outcomes in people with type 2 diabetes (T2DM). A total of 200 people with T2DM with different levels of DD and DS are to be enrolled.

At baseline, all participants are assessed for DD and DS, psychological and stress-related variables, self-reported self-management, HbA1c and inflammatory markers.

This is followed by a 4-week ambulatory assessment period including continuous glucose monitoring (CGM), continuous activity tracking and daily event sampling regarding sleep, stress levels, mood and diabetes-related issues; additionally, cortisol levels are assessed on four days within this period.

Three months after baseline, a follow-up assessment covers DD and DS levels, stress-related variables, self-reported self-management, HbA1c and final CGM assessment.

The analyses aim to establish risk factors/protective factors regarding DD and DS, their relative impact on glycaemic outcomes and potential mediation of the associations by behavioural (e.g. self-management, physical activity), physical (e.g. heart rate variability, inflammatory activity) and mental variables (subjective stress level) in T2DM.

Conditions

  • Diabetes Mellitus, Type 2
  • Depressive Symptoms
  • Stress, Psychological
  • Glucose, High Blood

Sponsors & Collaborators

  • German Center for Diabetes Research

    collaborator OTHER

  • University of Giessen

    collaborator OTHER

  • Helmholtz Zentrum München

    collaborator INDUSTRY

  • Norbert Hermanns

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2021-12-31
Completion
2022-03-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04438018 on ClinicalTrials.gov