Diabetes Mellitus, Type 1DIA-LINKNCT03811132
Towards a Better Understanding of Diabetes Distress, Depression and Poor Glycaemic Control (DIA-LINK Study)
An observational study of Diabetes Mellitus, Type 1 and Depressive Symptoms, run by Norbert Hermanns at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Depressive Symptoms, Stress, Psychological
- What is being tested?
- Observation
- How many people
- 208 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Jul 2018to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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".
Who may be able to join
- Type 1 Diabetes
- Diabetes duration at least 1 year
- Age between 18 and 70 years
- Sufficient German language skills
- Informed consent
- Smartphone available
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Diabetes Center Mergentheim
Bad Mergentheim, Baden-Wurttemberg, 97980
Research Institute of the Diabetes Academy Mergentheim, Diabetes Center Mergentheim
Bad Mergentheim, Baden-Wurttemberg, 97980
About this study
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)
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.
Read more
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.
Read the 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).
- Conditions
- Diabetes Mellitus, Type 1, Depressive Symptoms, Stress, Psychological, Glucose, High Blood
- Being tested
- Observation
- Medical subject headings
- Diabetes Mellitus, Type 1, Depression, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
There is no intervention or group-specific procedure per observation groups. Each of the 4 groups is monitored using ecological momentary assessment (EMA) for diabetes-specific problems, mood, stress, diabete distress via a smartphone app over 26 days. Study is observational/non-interventional; specific groups are enrolled to enable specific comparisons between people with/without depressive symptoms and/or diabetes distress; no specific interventions are offered to neither group.
| Study group | Role | What they receive |
|---|---|---|
| No DD or DS | No diabetes distress or depressive symptoms reported (CES-D < 22, PAID < 40) Receives: Other: Observation | |
| DD without DS | Diabetes distress but no depressive symptoms reported (CES-D < 22, PAID ≥ 40) Receives: Other: Observation | |
| DS without DD | Depressive symptoms but no diabetes distress reported (CES-D ≥ 22, PAID < 40) Receives: Other: Observation | |
| DD and DS | Both diabetes distress and depressive symptoms reported (CES-D ≥ 22, PAID ≥ 40) Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3-month follow-up
Secondary outcomes (17)
"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 that although the expression "time in range (TIR)" suggests a time measure, this is in fact estimated as a percentage score.
Measured: Continuous assessment over 4 weeks from baseline
Variability of glucose levels
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.
Measured: Continuous assessment over 4 weeks from baseline
"Time in hypoglycaemia" of glucose levels
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.
Measured: Continuous assessment over 4 weeks from baseline
"Time in hyperglycaemia" of glucose levels
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.
Measured: Continuous assessment over 4 weeks from baseline
Activity time
Activity time (in h/day) is measured continuously during the 4-week ambulatory assessment phase using a wearable health tracker/wristband ("Garmin vivosmart 4").
Measured: Continuous assessment over 4 weeks from baseline
Sleep time
Sleep time (in h/day) is measured continuously during the 4-week ambulatory assessment phase using a wearable health tracker/wristband ("Garmin vivosmart 4").
Measured: Continuous assessment over 4 weeks from baseline
Heart rate (variability)
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.
Measured: Continuous assessment over 4 weeks from baseline
Sleep quality
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.
Measured: Daily assessment over 4 weeks from baseline
Stress level
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.
Measured: Daily assessment over 4 weeks from baseline
Mood: Hedonic tone
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.
Measured: Daily assessment over 4 weeks from baseline
Mood: Arousal
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.
Measured: Daily assessment over 4 weeks from baseline
Diabetes-specific problems
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.
Measured: Daily assessment over 4 weeks from baseline
Cortisol
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).
Measured: 2 weeks after baseline
Marker of inflammation #1: high sensitivity C-reactive protein (hsCRP)
Estimated from venous blood sample (fasting blood collection) in mg/dl.
Measured: Baseline
Marker of inflammation #2: interleukin-6 (IL-6)
Estimated from venous blood sample (fasting blood collection) in pg/ml.
Measured: Baseline
Marker of inflammation #3: interleukin-18 (IL-18)
Estimated from venous blood sample (fasting blood collection) in pg/ml.
Measured: Baseline
Marker of inflammation #4: interleukin-1 receptor antagonist (IL-1Ra)
Estimated from venous blood sample (fasting blood collection) in pg/ml.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start1 Jul 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norbert Hermanns
- Sponsor type
- University, hospital or other
- Collaborators
- German Center for Diabetes Research, University of Giessen, Helmholtz Zentrum München
- Responsible party
- Sponsor-investigator, Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim
- Investigators
- Bernhard Kulzer, PhD, Principal investigator, Research Institute of the Diabetes Acadmey Mergentheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811132
- Sponsor's protocol ID
- NH082018
- Acronym
- DIA-LINK
- Status last verified
- Sep 2024
- First submitted
- 4 Jan 2019
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ehrmann D, Schmitt A, Priesterroth L, Kulzer B, Haak T, Hermanns N. Time With Diabetes Distress and Glycemia-Specific Distress: New Patient-Reported Outcome Measures for the Psychosocial Burden of Diabetes Using Ecological Momentary Assessment in an Observational Study. Diabetes Care. 2022 Jul 7;45(7):1522-1531. doi: 10.2337/dc21-2339.
PubMed 35613338Ehrmann D, Hermanns N, Schmitt A, Klinker LY, Bergis D, Kulzer B. Temporal dynamics of daily diabetes-specific burdens using intensive longitudinal data: the central role of feelings of guilt within a multilevel network analysis. Diabetologia. 2026 Sep 21. doi: 10.1007/s00125-026-06869-1. Online ahead of print.
PubMed 42766003Schmitt 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.
PubMed 37498716
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03811132
- Acronym / sponsor ID
- DIA-LINK / NH082018
- Conditions
- Diabetes Mellitus, Type 1, Depressive Symptoms, Stress, Psychological, Glucose, High Blood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Norbert HermannsUniversity, hospital or other
- Collaborators
- German Center for Diabetes Research, University of Giessen, Helmholtz Zentrum München
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 22 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No DD or DS | – | Other: ObservationNo diabetes distress or depressive symptoms reported (CES-D < 22, PAID < 40) |
| DD without DS | – | Other: ObservationDiabetes distress but no depressive symptoms reported (CES-D < 22, PAID ≥ 40) |
| DS without DD | – | Other: ObservationDepressive symptoms but no diabetes distress reported (CES-D ≥ 22, PAID < 40) |
| DD and DS | – | Other: ObservationBoth diabetes distress and depressive symptoms reported (CES-D ≥ 22, PAID ≥ 40) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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".
Key inclusion criteria (6 listed)
- Type 1 Diabetes
- Diabetes duration at least 1 year
- Age between 18 and 70 years
- Sufficient German language skills
- Informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationThere is no intervention or group-specific procedure per observation groups. Each of the 4 groups is monitored using ecological momentary assessment (EMA) for diabetes-specific problems, mood, stress, diabete distress via a smartphone app over 26 days. Study is observational/non-interventional; specific groups are enrolled to enable specific comparisons between people with/without depressive symptoms and/or diabetes distress; no specific interventions are offered to neither group. | Other | DD and DS, DD without DS, DS without DD, No DD or DS |
Primary outcome
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.
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.
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.
17 secondary outcomes
"Time in range" of glucose levels
Time frame: Continuous assessment over 4 weeks from baseline
Variability of glucose levels
Time frame: Continuous assessment over 4 weeks from baseline
"Time in hypoglycaemia" of glucose levels
Time frame: Continuous assessment over 4 weeks from baseline
"Time in hyperglycaemia" of glucose levels
Time frame: Continuous assessment over 4 weeks from baseline
Activity time
Time frame: Continuous assessment over 4 weeks from baseline
Sleep time
Time frame: Continuous assessment over 4 weeks from baseline
Heart rate (variability)
Time frame: Continuous assessment over 4 weeks from baseline
Sleep quality
Time frame: Daily assessment over 4 weeks from baseline
Stress level
Time frame: Daily assessment over 4 weeks from baseline
Mood: Hedonic tone
Time frame: Daily assessment over 4 weeks from baseline
Mood: Arousal
Time frame: Daily assessment over 4 weeks from baseline
Diabetes-specific problems
Time frame: Daily assessment over 4 weeks from baseline
Cortisol
Time frame: 2 weeks after baseline
Marker of inflammation #1: high sensitivity C-reactive protein (hsCRP)
Time frame: Baseline
Marker of inflammation #2: interleukin-6 (IL-6)
Time frame: Baseline
Marker of inflammation #3: interleukin-18 (IL-18)
Time frame: Baseline
Marker of inflammation #4: interleukin-1 receptor antagonist (IL-1Ra)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Results publication: PubMed 35613338Ehrmann D, Schmitt A, Priesterroth L, Kulzer B, Haak T, Hermanns N. Time With Diabetes Distress and Glycemia-Specific Distress: New Patient-Reported Outcome Measures for the Psychosocial Burden of Diabetes Using Ecological Momentary Assessment in an Observational Study. Diabetes Care. 2022 Jul 7;45(7):1522-1531. doi: 10.2337/dc21-2339.
- Derived from this study: PubMed 42766003Ehrmann D, Hermanns N, Schmitt A, Klinker LY, Bergis D, Kulzer B. Temporal dynamics of daily diabetes-specific burdens using intensive longitudinal data: the central role of feelings of guilt within a multilevel network analysis. Diabetologia. 2026 Sep 21. doi: 10.1007/s00125-026-06869-1. Online ahead of print.
- Derived from this study: PubMed 37498716Schmitt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernhard Kulzer, PhD principal investigator
Research Institute of the Diabetes Acadmey Mergentheim
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1 and Depressive Symptoms, run by Norbert Hermanns at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: 3-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03811132, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.