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

NCT ID: NCT04438018

Last Updated: 2022-04-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 205 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2022-03-31

Brief 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.

Detailed Description

DIA-LINK2 is a prospective observational study analysing longitudinal associations between diabetes distress (DD), depressive symptoms (DS) and glycaemic outcomes in people with type 2 diabetes (T2DM). A variety of behavioural, physical and mental variables are assessed to analyse the mediating links between DD, DS and glycaemia.

A total of 200 people with T2DM are enrolled according to DD (PAID ≥ / < 40) and DS (CES-D ≥ / < 22) scores so that four groups (n = 50 persons each) with varying levels of DD and DS are established: 1. PAID < 40 and CES-D < 22 (no DD, no DS); 2. PAID ≥ 40 and CES-D < 22 (DD, no DS); 3. PAID < 40 and CES-D ≥ 22 (DS, no DD); 4. PAID ≥ 40 and CES-D ≥ 22 (DD and DS).

At baseline, all participants are assessed for relevant psychological and stress-related variables (daily hassles, life events, diabetes-related problems and fears, coping styles, resilience, diabetes acceptance, depression) as well as self-reported diabetes self-management using validated self-report scales and interviews; HbA1c and selected markers of inflammation (hsCRP, IL-6, IL-18, IL1Ra) are analysed from venous blood samples.

This is followed by a 4-week ambulatory assessment period including continuous glucose monitoring (CGM) (to establish time in range, glucose variability and times in hypo/hyperglycaemia), continuous activity tracking regarding general activity, movement, sleep and heart rate using a wristband as well as event sampling regarding sleep quality, stress levels, mood and diabetes-related issues four times daily using a smartphone app. Additionally, salivary cortisol levels are estimated on four consecutive days (each including a morning, afternoon and night time sample) within this period.

Three months after baseline, a follow-up assessment is performed which includes self-report measures of DD and DS, stress-related variables and diabetes self-management, HbA1c estimation from venous blood samples and final CGM assessment over 14 days.

The collected data are used to analyse 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.

The findings shall be used to develop personalised interventions for people with diabetes and comorbid mental conditions (DD and DS).

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

No DD or DS

No diabetes distress or depressive symptoms reported (CES-D \< 22, PAID \< 40)

No interventions assigned to this group

DD without DS

Diabetes distress but no depressive symptoms reported (CES-D \< 22, PAID ≥ 40)

No interventions assigned to this group

DS without DD

Depressive symptoms but no diabetes distress reported (CES-D ≥ 22, PAID \< 40)

No interventions assigned to this group

DD and DS

Both diabetes distress and depressive symptoms reported (CES-D ≥ 22, PAID ≥ 40)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Type 2 Diabetes
• Diabetes duration at least 1 year
• Age between 18 and 70 years
• Sufficient German language skills
• Informed consent
• Smartphone available

Exclusion Criteria

• Capacity for consent lacking
• Illness with significant impairment of cognitive functioning (e.g. dementia)
• Severe somatic illness or mental disorder which interferes with study participation or might confound the results (dialysis-dependent renal failure; heart failure, i.e. New York Heart Association (NYHA) class III or IV; cancer requiring treatment; schizophrenia/psychotic disorder; bipolar disorder; severe eating disorder F50.0/F50.2; personality disorder)
• Terminal illness
• Being bedridden

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Center for Diabetes Research

OTHER

Sponsor Role: collaborator

University of Giessen

OTHER

Sponsor Role: collaborator

Helmholtz Zentrum München

INDUSTRY

Sponsor Role: collaborator

Norbert Hermanns

OTHER

Sponsor Role: lead

Responsible Party

Norbert Hermanns

Prof. Dr. phil.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Research Institute of the Diabetes Academy Mergentheim, Diabetes Center Mergentheim

Bad Mergentheim, Baden-Wurttemberg, Germany

Countries

Germany

References

Schmitt A, Ehrmann D, Kuniss N, Muller N, Kulzer B, Hermanns N. Assessing fear of complications in people with type 1 and type 2 diabetes with the Fear of Diabetes Complications Questionnaire. Health Psychol. 2023 Sep;42(9):674-685. doi: 10.1037/hea0001304. Epub 2023 Jul 27.

Reference Type: DERIVED

PMID: 37498716 (View on PubMed)

Other Identifiers

NH082018_2

Identifier Type: -

Identifier Source: org_study_id