Towards a Better Understanding of Diabetes Distress, Depression and Poor Glycaemic Control Leading to Personalised Interventions for People With Diabetes (DIA-LINK2 Study)

• Conditions: E11; F39; Type 2 diabetes mellitus; Unspecified mood [affective] disorder

• Registration Number: DRKS00022384
• Lead Sponsor: Forschungsinstitut der Diabetes-Akademie Bad Mergentheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-08
• Study Completion: 2022-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 205

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; 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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.