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Towards a Better Understanding of Diabetes Distress, Depression and Poor Glycaemic Control (DIA-LINK Study)

NCT03811132 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 208

Last updated 2024-09-27

No results posted yet for this study

Summary

The DIA-LINK Study 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 1 diabetes (T1DM). A total of 200 people with T1DM 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 T1DM.

Conditions

  • Diabetes Mellitus, Type 1
  • Depressive Symptoms
  • Stress, Psychological
  • Glucose, High Blood

Interventions

OTHER

Observation

There is no intervention or group-specific procedure per observation groups. Each of the 4 groups is monitored using ecological momentary assessment (EMA) for diabetes-specific problems, mood, stress, diabete distress via a smartphone app over 26 days. Study is observational/non-interventional; specific groups are enrolled to enable specific comparisons between people with/without depressive symptoms and/or diabetes distress; no specific interventions are offered to neither group.

Sponsors & Collaborators

  • German Center for Diabetes Research

    collaborator OTHER

  • University of Giessen

    collaborator OTHER

  • Helmholtz Zentrum München

    collaborator INDUSTRY

  • Norbert Hermanns

    lead OTHER

Principal Investigators

  • Bernhard Kulzer, PhD · Research Institute of the Diabetes Acadmey Mergentheim

Eligibility

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

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2020-06-30
Completion
2020-06-30

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 NCT03811132 on ClinicalTrials.gov