The Impact of the COVID-19 Pandemic on Diabetes Management

Study Overview
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Brief Summary
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The CoDiaM study examines how diabetes management and outcomes are changing during the COVID-19 pandemic and whether these changes are influenced by socio-demographic factors, health literacy, self-efficacy and perceived social support.

Detailed Description
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The Covid-19 pandemic created new challenges for patients with diabetes and their treating physicians. In order to protect people from SARS-COV-2 infections, social contacts were reduced by restrictions on many areas of social life. As a side effect, these measures could have also led to changes in the self-management of patients with diabetes mellitus, such as lack of physical exercise, less healthy dietary behavior, and a reduced intensity of medical care. These possible changes may be associated with poorer control of blood glucose, cholesterol, and blood pressure. Therefore, the CoDiaM study will investigate how management and outcomes of diabetes are changing during the pandemic and identify associated factors. The study is based on data of patients treated in three GP practices specialized on diabetes treatment in Hamburg, Germany. Data collection will include a written patient survey and extraction of clinical data from patient records. The patient's survey includes sociodemographic data and validated instruments to assess diabetes self-management (DSMQ), health literacy (HLS-EU-Q16), self-efficacy (General Self-efficacy scale) and perceived social support (F-SozU K14). Data will be analyzed by descriptive statistics and multivariable, multilevel linear and logistic regression analyses adjusted for possible confounders and random effects on the practice level.

Official Title
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The Impact of the COVID-19 Pandemic on Diabetes Management (CoDiaM)

Conditions
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Type 2 Diabetes, Type 1 Diabetes Mellitus

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: being 18 years or older, and having diabetes type 2 or type 1, and having consulted the practice at least once in 2019 AND at least once in 2020 Exclusion Criteria: no capacity to consent (e.g. because of dementia) insufficient German language skills to understand the questions in the questionnaire not able to fill out the questionnaire (e.g. because of blindness) gestational diabetes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with diabetes mellitus<br>Approximately 750 patients with diabetes mellitus from 3 GP practices specialized on diabetes treatment | Other: No intervention<br>* Care as usual<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c (HbA1c) | Data on outcome will be extracted from the GP's patient record | 01.01.2019 to 31.12.2021 |