Trial document




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  DRKS00016593

Trial Description

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Title

Towards a Better Understanding of Diabetes Distress, Depression and Poor Glycaemic Control Leading to Personalised Interventions for People With Diabetes (DIA-LINK Study)

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Trial Acronym

DIA-LINK

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URL of the Trial

http:///

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Brief Summary in Lay Language

The DIA-LINK Study is a prospective observational study analysing associations and mediating links between diabetes distress (DD) (= diabetes-related emotional burden), depressive symptoms (DS) and glycaemic outcomes (= characteristics of blood glucose control) 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 the beginning ("baseline assessment") each participant is assessed for DD and DS using questionnaires and additional psychological and stress-related variables, self-reported diabetes self-management behaviour, HbA1c (= measure of blood glucose levels over 8 to 12 weeks) and other laboratory variables (e.g. markers of inflammation) are collected.
This is followed by a 4-week assessment period within the persons normal daily surroundings ("ambulatory assessment") including continuous glucose monitoring (CGM), continuous activity tracking and short surveys regarding sleep, stress levels, mood and diabetes-related issues using smartphone four times daily; additionally, cortisol (= stress hormone) levels are assessed four times within this period.
Three months after baseline, a final ("follow-up") assessment covers DD and DS levels, stress-related variables, self-reported self-management, HbA1c and final CGM assessment.

The study aims 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, activity), physical (e.g. heart rate variability, inflammatory processes) and mental variables (e.g. subjective stress level) in people with T1DM.

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Brief Summary in Scientific Language

The DIA-LINK Study is a prospective observational study analysing associations between diabetes distress (DD), depressive symptoms (DS) and glycaemic outcomes in people with type 1 diabetes (T1DM). 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 T1DM 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 etc.), 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 aspects, stress events and diabetes-related issues four times daily using a smartphone app. Additionally, cortisol levels are estimated from saliva samples on four consecutive days (each including a morning, afternoon and night 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 T1DM.

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

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Organizational Data

  •   DRKS00016593
  •   2019/01/21
  •   2019/01/16
  •   yes
  •   Approved
  •   NH 082018, Ethik-Kommission der Deutschen Gesellschaft für Psychologie (DGPs)
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Secondary IDs

  •   NCT03811132  (ClinicalTrials.gov)
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Health Condition or Problem studied

  •   E10 -  Type 1 diabetes mellitus
  •   F39 -  Unspecified mood [affective] disorder
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Interventions/Observational Groups

  •   No diabetes distress or depressive symptoms reported (Center for Epidemiologic Studies Depression Scale (CES-D) score < 22, Problem Areas in Diabetes Scale (PAID) score < 40)
  •   Diabetes distress but no depressive symptoms reported (CES-D < 22, PAID ≥ 40)
  •   Depressive symptoms but no diabetes distress reported (CES-D ≥ 22, PAID < 40)
  •   Both diabetes distress and depressive symptoms reported (CES-D ≥ 22, PAID ≥ 40)
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

HbA1c (estimated in %-points; mmol/mol values are calculated thereof) as a measure of glycaemic levels during past three months. It is estimated from venous blood samples 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.

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Secondary Outcome

"Time in range" of glucose levels = Percentage of glucose values measured using CGM ("FreeStyle Libre 2" glucose monitoring system) during 4-week ambulatory assessment which are between 70 and 180 mg/dl (out of all measured values). Note: Although the expression "time in range (TIR)" suggests a time measure, this is in fact estimated as a percentage score.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/03/18
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

Type 1 diabetes; Diabetes duration at least 1 year; age between 18 and 70 years; sufficient German language skills; informed consent; smartphone available

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Exclusion Criteria

Capacity for consent lacking; significant impairment of cognitive functioning (e.g. mental retardation; dementia; cognitive dysfunction); severe somatic illness or mental disorder (anamnestic) 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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Forschungsinstitut der Diabetes-Akademie Bad Mergentheim
    • Mr.  Prof. Dr. phil.  Norbert  Hermanns 
    • Johann-Hammer-Straße 24
    • 97980  Bad Mergentheim
    • Germany
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    •   (+49) (0)7931-594-553
    •   (+49) (0)7931-594-89-553
    •   hermanns at fidam.de
    •   [---]*
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    • Forschungsinstitut der Diabetes-Akademie Bad Mergentheim
    • Mr.  Prof. Dr. phil.  Norbert  Hermanns 
    • Johann-Hammer-Straße 24
    • 97980  Bad Mergentheim
    • Germany
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    •   (+49) (0)7931-594-553
    •   (+49) (0)7931-594-89-553
    •   hermanns at fidam.de
    •   [---]*
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    • Diabetes-Akademie Bad Mergentheim e.V.
    • Mr.  Dr. phil.  Andreas  Schmitt 
    • Theodor-Klotzbücher-Str. 12
    • 97980  Bad Mergentheim
    • Germany
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Sources of Monetary or Material Support

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    • Deutsches Zentrum für Diabetesforschung (DZD)
    • Ingolstädter Landstraße 1
    • 85764 
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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    • Diabetes-Akademie Bad Mergentheim e.V.
    • Theodor-Klotzbücher-Straße 12
    • 97980 
    • Germany
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.