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Trial record 1 of 1 for:    NCT03811132
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Towards a Better Understanding of Diabetes Distress, Depression and Poor Glycaemic Control (DIA-LINK Study) (DIA-LINK)

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ClinicalTrials.gov Identifier: NCT03811132
Recruitment Status : Completed
First Posted : January 22, 2019
Last Update Posted : September 14, 2022
Sponsor:
Collaborators:
German Center for Diabetes Research
University of Giessen
Helmholtz Zentrum München
Information provided by (Responsible Party):
Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim

Brief 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.


Condition or disease
Diabetes Mellitus, Type 1 Depressive Symptoms Stress, Psychological Glucose, High Blood

Detailed Description:

The DIA-LINK Study is a prospective observational study analysing longitudinal 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), 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 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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Study Type : Observational
Actual Enrollment : 208 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Towards a Better Understanding of Diabetes Distress, Depression and Poor Glycaemic Control Leading to Personalised Interventions for People With Diabetes (DIA-LINK Study)
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
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)



Primary Outcome Measures :
  1. Depressive symptoms [ Time Frame: 3-month follow-up ]
    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.

  2. Diabetes Distress [ Time Frame: 3-month follow-up ]
    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. HbA1c [ Time Frame: 3-month follow-up ]
    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.


Secondary Outcome Measures :
  1. "Time in range" of glucose levels [ Time Frame: Continuous assessment over 4 weeks from baseline ]
    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 that although the expression "time in range (TIR)" suggests a time measure, this is in fact estimated as a percentage score.

  2. Variability of glucose levels [ Time Frame: Continuous assessment over 4 weeks from baseline ]
    Estimated by the coefficient of variation (range 0 to 1) of all glucose values measured using CGM ("FreeStyle Libre 2" glucose monitoring system) during the 4-week ambulatory assessment phase.

  3. "Time in hypoglycaemia" of glucose levels [ Time Frame: Continuous assessment over 4 weeks from baseline ]
    Percentage of glucose values measured using CGM ("FreeStyle Libre 2" glucose monitoring system) during 4-week ambulatory assessment phase which are below 70 mg/dl (out of all measured values). Note that although the expression "time in hypoglycaemia" suggests a time measure, this is in fact estimated as a percentage score.

  4. "Time in hyperglycaemia" of glucose levels [ Time Frame: Continuous assessment over 4 weeks from baseline ]
    Percentage of glucose values measured using CGM ("FreeStyle Libre 2" glucose monitoring system) during 4-week ambulatory assessment phase which are over 180 mg/dl (out of all measured values). Note that although the expression "time in hyperglycaemia" suggests a time measure, this is in fact estimated as a percentage score.

  5. Activity time [ Time Frame: Continuous assessment over 4 weeks from baseline ]
    Activity time (in h/day) is measured continuously during the 4-week ambulatory assessment phase using a wearable health tracker/wristband ("Garmin vivosmart 4").

  6. Sleep time [ Time Frame: Continuous assessment over 4 weeks from baseline ]
    Sleep time (in h/day) is measured continuously during the 4-week ambulatory assessment phase using a wearable health tracker/wristband ("Garmin vivosmart 4").

  7. Heart rate (variability) [ Time Frame: Continuous assessment over 4 weeks from baseline ]
    Heart rate (in beats/minute) is measured continuously during the 4-week ambulatory assessment phase using a wearable health tracker/wristband ("Garmin vivosmart 4"). Heart rate variability is calculated thereof using the coefficient of variation.

  8. Sleep quality [ Time Frame: Daily assessment over 4 weeks from baseline ]
    Sleep quality during the past night is assessed daily during the 4-week ambulatory assessment phase using items adapted from the Pittsburgh Sleep Quality Index (PSQI) for use in an ecological momentary assessment (EMA) survey via smartphone. The items assess/enable estimation of 1. subjective sleep quality; 2. sleep latency; 3. sleep duration; and 4. sleep efficiency. Each aspect is scored on a 4-point scale from 0 (no problem) to 3 (great problem), and scores are summed to a total ranging from 0 to 12, so that higher scores reflect worse overall sleep quality.

  9. Stress level [ Time Frame: Daily assessment over 4 weeks from baseline ]
    Stress level is assessed four times daily during the 4-week ambulatory assessment phase assessed using the single item "How stressed are you feeling right now?" and a Likert scale from 0 - "not at all stressed" to 10 - "very strongly stressed" in an ecological momentary assessment (EMA) survey via smartphone.

  10. Mood: Hedonic tone [ Time Frame: Daily assessment over 4 weeks from baseline ]
    Mood is assessed twice daily during the 4-week ambulatory assessment phase using selected items from the University of Wales Institute of Science and Technology (UWIST) Mood Adjective Checklist (UMACL) in an ecological momentary assessment (EMA) survey via smartphone. 12 of the 29 UMACL items were selected based on their significant associations with glycaemic outcomes from CGM assessment (own data set); each four of them reflect positive and negative hedonic tone and energetic and tense arousal. Responses are given on a four-point Likert scale (0 - "definitely not" / 1 - "slightly not" / 2 - "slightly" / 3 - "definitely) reflecting the presence or absence of each aspects. Item scores are summed/averaged to scale scores (from 0 to 3) reflecting hedonic tone and arousal levels; higher scores reflect higher hedonic tone and arousal levels, respectively.

  11. Mood: Arousal [ Time Frame: Daily assessment over 4 weeks from baseline ]
    Mood is assessed twice daily during the 4-week ambulatory assessment phase using selected items from the University of Wales Institute of Science and Technology (UWIST) Mood Adjective Checklist (UMACL) in an ecological momentary assessment (EMA) survey via smartphone. 12 of the 29 UMACL items were selected based on their significant associations with glycaemic outcomes from CGM assessment (own data set); each four of them reflect positive and negative hedonic tone and energetic and tense arousal. Responses are given on a four-point Likert scale (0 - "definitely not" / 1 - "slightly not" / 2 - "slightly" / 3 - "definitely) reflecting the presence or absence of each aspects. Item scores are summed/averaged to scale scores (from 0 to 3) reflecting hedonic tone and arousal levels; higher scores reflect higher hedonic tone and arousal levels, respectively.

  12. Diabetes-specific problems [ Time Frame: Daily assessment over 4 weeks from baseline ]
    Diabetes-specific problems are assessed daily during the 4-week ambulatory assessment phase using six items adapted from the Problem Areas In Diabetes Scale and additional items in an ecological momentary assessment (EMA) survey via smartphone. Responses are given on a Likert scale from 0 - "not at all" to 10 - "very strong". Item scores are averaged to a scale ranging from 0 to 10, whereby higher scores indicate greater problems.

  13. Cortisol [ Time Frame: 2 weeks after baseline ]
    Cortisol level (in μg/dl) is estimated from saliva samples collected at fixed day times (morning; afternoon; late evening) on four consecutive days (Sat/Sun/Mon/Tue) during ambulatory assessment period. Collection date within 4 week-period is from the beginning of the third week (approx. 2 weeks after baseline). Samples are analysed using electrochemiluminescence (Cobas 6000 analyser).

  14. Marker of inflammation #1: high sensitivity C-reactive protein (hsCRP) [ Time Frame: Baseline ]
    Estimated from venous blood sample (fasting blood collection) in mg/dl.

  15. Marker of inflammation #2: interleukin-6 (IL-6) [ Time Frame: Baseline ]
    Estimated from venous blood sample (fasting blood collection) in pg/ml.

  16. Marker of inflammation #3: interleukin-18 (IL-18) [ Time Frame: Baseline ]
    Estimated from venous blood sample (fasting blood collection) in pg/ml.

  17. Marker of inflammation #4: interleukin-1 receptor antagonist (IL-1Ra) [ Time Frame: Baseline ]
    Estimated from venous blood sample (fasting blood collection) in pg/ml.


Other Outcome Measures:
  1. Coping with stress [ Time Frame: Baseline ]
    Coping styles regarding stressful events are assessed at baseline using the 21-item short form of the Coping Inventory for Stressful Situations (CISS-21). The scale enables estimation of three scale scores reflecting task-oriented coping, emotion-oriented coping and avoidance coping (each seven items). Responses are given on a five-point Likert scale (1 - "not at all" to 5 - "very much"). Item scores are summed to scale scores ranging from 7 to 35, whereby higher scores reflect higher use of the corresponding coping style. Note: This outcome variable is assessed to be used as a mediator or moderator or control factor in the analyses of associations between primary and secondary outcome variables (e.g. between diabetes distress and glycaemic levels).

  2. Resilience [ Time Frame: Baseline ]
    Resilience is assessed at baseline using the Resilience Scale (RS-13). Its 13 items are scored on a 7-point Likert scale (from 1 - "I do not agree" to 7 - "I fully agree"). Item scores are summed to a total score ranging from 13 to 91, whereby higher scores indicate greater resilience. Note: This outcome variable is assessed to be used as a mediator or moderator or control factor in the analyses of associations between primary and secondary outcome variables (e.g. between diabetes distress and glycaemic levels).

  3. Life events [ Time Frame: Baseline ]
    Critical life events during the past 12 months are assessed at baseline using the German "Fragebogen zu Kritischen Lebensereignissen (FKL)" (Questionnaire for Critical Life Events FKL). Emotional distress related to each of 27 possible events which occured during the past 12 months is rated on a 3-point scale (from 0 - "not at all distressing" to 2 - "very much distressing"), and scores are summed to a total score reflecting the burden of recent life events (range from 0 to 54, with higher values reflecting higher burden). Note: This outcome variable is assessed to be used as a mediator or moderator or control factor in the analyses of associations between primary and secondary outcome variables (e.g. between diabetes distress and glycaemic levels).

  4. Diabetes acceptance [ Time Frame: Baseline ]
    Diabetes acceptance is assessed at baseline using a 10-item short form of the Diabetes Acceptance Scale (DAS). Each items is scored on a 3-point Likert scale from 0 - "never true for me" to 3 - "always tue for me". Items scores are summed to a total score (from 0 to 30); higher scores reflect higher diabetes acceptance. Note: This outcome variable is assessed to be used as a mediator or moderator or control factor in the analyses of associations between primary and secondary outcome variables (e.g. between diabetes distress and glycaemic levels).

  5. Diabetes self-management [ Time Frame: Baseline ]
    Diabetes self-management is assessed at baseline using the revised version of the Diabetes Self-Management Questionnaire (DSMQ), a 27-item scale reflecting different behaviours/activities related to the self-management of the condition during the past eight weeks. Each item is scored on a 4-point Likert scale (from 0 - "does not apply to me" to 3 - "applies to me very much"), and items scores are summed/transformed to a total score (range 0 to 10) reflecting overall diabetes self-management. Note: This outcome variable is assessed to be used as a mediator or moderator or control factor in the analyses of associations between primary and secondary outcome variables (e.g. between diabetes distress and glycaemic levels).

  6. Type 1 diabetes-specific problems [ Time Frame: Baseline ]
    Type 1 diabetes-specific problems are assessed at baseline using the Diabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS), a 28-item scale reflecting diverse problems related to living with type 1 diabetes. Items scores (from 1 - "not a problem" to 6 - "a very serious problem") are summed to a total ranging from 0 to 168 with higher values reflecting more problems. Subscale scores reflecting powerlessness, management distress, hypoglycemia distress, negative social perceptions, eating distress, physician distress and friend/family distress can also be calculated. Note: This outcome variable is assessed to be used as a mediator or moderator or control factor in the analyses of associations between primary and secondary outcome variables (e.g. between diabetes distress and glycaemic levels).

  7. Fear of hypoglycaemia [ Time Frame: Baseline ]
    Fear of hypoglycaemia is assessed at baseline using the 11-item short form of the Hypoglycaemia Fear Survey-II (HFS-II). The occurence of eleven hypoglycaemia-related worries and avoidance behaviours during the past four weeks is rated on a five-point Likert Scale (0 = never to 4 - "almost always"). Item scores are summed to a total score ranging from 0 to 44, whereby higher values indicate higher fear of hypoglycaemia. Note: This outcome variable is assessed to be used as a mediator or moderator or control factor in the analyses of associations between primary and secondary outcome variables (e.g. between diabetes distress and glycaemic levels).

  8. Fear of diabetes complications [ Time Frame: Baseline ]
    Fear of diabetes complications is at baseline assessed using a 6-item short form of the Fear of Complications Questionnaire (FCQ). The questionnaire requests the frequencies of worries and fears regarding risks of developing long-term complications of diabetes. Each item is rated on a four-point Likert Scale (0 = never/rarely to 3 - "very often"). Item scores are summed to a total score ranging from 0 to 18, whereby higher values indicate higher fear of diabetes complications. Note: This outcome variable is assessed to be used as a mediator or moderator or control factor in the analyses of associations between primary and secondary outcome variables (e.g. between diabetes distress and glycaemic levels).


Biospecimen Retention:   Samples Without DNA
HbA1c; Cortisol; Markers of inflammation (hsCRP, IL-6, IL-1Ra, IL-18)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People with T1DM 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".
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811132


Locations
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Germany
Research Institute of the Diabetes Academy Mergentheim, Diabetes Center Mergentheim
Bad Mergentheim, Baden-Wuerttemberg, Germany, 97980
Diabetes Center Mergentheim
Bad Mergentheim, BW, Germany, 97980
Sponsors and Collaborators
Norbert Hermanns
German Center for Diabetes Research
University of Giessen
Helmholtz Zentrum München
Investigators
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Principal Investigator: Bernhard Kulzer, PhD Research Institute of the Diabetes Acadmey Mergentheim
Publications of Results:
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Responsible Party: Norbert Hermanns, Prof. Dr. phil., Forschungsinstitut der Diabetes Akademie Mergentheim
ClinicalTrials.gov Identifier: NCT03811132    
Other Study ID Numbers: NH082018
First Posted: January 22, 2019    Key Record Dates
Last Update Posted: September 14, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Depression
Stress, Psychological
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Behavioral Symptoms
Autoimmune Diseases
Immune System Diseases