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

NCT04438018 | Completed

• 1 other identifier: NH082018_2
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Depressive symptoms

  Depressive symptoms are assessed using the 20-item Center for Epidemiologic Studies Depression Scale (CES-D), covering 20 symptoms of depression. Frequencies of the symptoms during the past week are scored on a 4-point Likert scale (from 0 - "rarely or non of the time" to 3 - "most or all of the time"). Item scores are summed to a total score ranging from 0 to 60, whereby higher values reflect higher depressive symptoms. A cut-off point at ≥ 22 points (found to have the best likelihood ratio for detecting depression within the German population) is used to establish elevated depressive symptoms in this study.

  3-month follow-up

• Diabetes Distress

  Diabetes Distress is assessed as using the 20-item Problem Areas In Diabetes Scale (PAID). 20 potential problems related to living with diabetes are rated on a 5-point Likert scale (from 0 - "not a problem" to 4 - "serious problem"). Item scores are summed/transformed to a total score ranging from 0 to 100, whereby higher values reflect higher diabetes distress. A cut-off point at ≥ 40 points is commonly used to establish high diabetes distress, so too in this study.

  3-month follow-up

• HbA1c

  HbA1c (estimated in %-points; mmol/mol values are calculated thereof) is used as a measure of glycaemic levels during past 3 months. It is estimated from a venous blood sample using high performance liquid chromatography (Tosho G11 analyser; meeting International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) standard) in this study. Higher values indicate less optimal glycaemic control, and values above 7.5% (58 mmol/mol) are considered to indicate glycaemic levels in need of improvement.

  3-month follow-up

Secondary Outcomes (17)

• "Time in range" of glucose levels

  Continuous assessment over 4 weeks from baseline

• Variability of glucose levels

  Continuous assessment over 4 weeks from baseline

• "Time in hypoglycaemia" of glucose levels

  Continuous assessment over 4 weeks from baseline

• "Time in hyperglycaemia" of glucose levels

  Continuous assessment over 4 weeks from baseline

• Activity time

  Continuous assessment over 4 weeks from baseline

Other Outcomes (8)

• Coping with stress

  Baseline

• Resilience

  Baseline

• Life events

  Baseline

Study Arms (4)

No DD or DS

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

DD without DS

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

DS without DD

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

DD and DS

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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".

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Norbert Hermanns: lead
• German Center for Diabetes Research: collaborator
• University of Giessen: collaborator
• Helmholtz Zentrum München: collaborator

Study Sites (1)

Research Institute of the Diabetes Academy Mergentheim, Diabetes Center Mergentheim

Bad Mergentheim, Baden-Wurttemberg, 97980, Germany

Location

Related Publications (1)

• 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.

  PMID: 37498716 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

HbA1c; Cortisol; Markers of inflammation (hsCRP, IL-6, IL-1Ra, IL-18)

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Depression; Stress, Psychological

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. phil.

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: April 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)