Clinical trial NCT04438018: Towards a Better Understanding of Diabetes Distress, Depression and Poor Glycaemic Control in T2DM
Official title: Towards a Better Understanding of Diabetes Distress, Depression and Poor Glycaemic Control Leading to Personalised Interventions for People With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Depressive Symptoms
Stress, Psychological
Glucose, High Blood
Lead sponsor: Forschungsinstitut der Diabetes Akademie Mergentheim
Sponsor class: OTHER
Collaborators: name: German Center for Diabetes Research
name: University of Giessen
name: Helmholtz Zentrum München
First posted: 2020-06-18
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with T2DM with different levels of diabetes distress (DD) and/or depressive symptoms (DS): Four groups of n = 50 persons each reporting 1. "no DD/no DS" vs. 2. "DD/no DS" vs. 3. "DS/no DD" vs. "DD and DS".

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).

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

Primary outcomes:
measure: Depressive symptoms
timeFrame: 3-month follow-up
measure: Diabetes Distress
timeFrame: 3-month follow-up
measure: HbA1c
timeFrame: 3-month follow-up
Secondary outcomes:
measure: "Time in range" of glucose levels
timeFrame: Continuous assessment over 4 weeks from baseline
measure: Variability of glucose levels
timeFrame: Continuous assessment over 4 weeks from baseline
measure: "Time in hypoglycaemia" of glucose levels
timeFrame: Continuous assessment over 4 weeks from baseline
measure: "Time in hyperglycaemia" of glucose levels
timeFrame: Continuous assessment over 4 weeks from baseline
measure: Activity time
timeFrame: Continuous assessment over 4 weeks from baseline
measure: Sleep time
timeFrame: Continuous assessment over 4 weeks from baseline
measure: Heart rate (variability)
timeFrame: Continuous assessment over 4 weeks from baseline
measure: Self-reported sleep quality
timeFrame: Daily assessment over 4 weeks from baseline
measure: Stress level
timeFrame: Daily assessment over 4 weeks from baseline
measure: Mood: Hedonic tone
timeFrame: Daily assessment over 4 weeks from baseline
measure: Mood: Arousal
timeFrame: Daily assessment over 4 weeks from baseline
measure: Diabetes-specific problems
timeFrame: Daily assessment over 4 weeks from baseline
measure: Cortisol
timeFrame: 2 weeks after baseline
measure: Marker of inflammation #1: high sensitivity C-reactive protein (hsCRP)
timeFrame: Baseline
measure: Marker of inflammation #2: interleukin-6 (IL-6)
timeFrame: Baseline
measure: Marker of inflammation #3: interleukin-18 (IL-18)
timeFrame: Baseline
measure: Marker of inflammation #4: interleukin-1 receptor antagonist (IL-1Ra)
timeFrame: Baseline
Other outcomes:
measure: Coping with stress
timeFrame: Baseline
measure: Resilience
timeFrame: Baseline
measure: Life events
timeFrame: Baseline
measure: Diabetes acceptance
timeFrame: Baseline
measure: Diabetes self-management
timeFrame: Baseline
measure: Diabetes-specific problems
timeFrame: Baseline
measure: Fear of hypoglycaemia
timeFrame: Baseline
measure: Fear of diabetes complications
timeFrame: Baseline
Locations:
city: Bad Mergentheim
country: Germany
facility: Research Institute of the Diabetes Academy Mergentheim, Diabetes Center Mergentheim
state: Baden-Wuerttemberg
Study officials:
References: