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Completed

NCT Number: NCT04821921

The Impact of the COVID-19 Pandemic on Diabetes Management

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

Care as usual

Primary outcomes

  1. Hemoglobin A1c (HbA1c)

    Time frame: 01.01.2019 to 31.12.2021

    Data on outcome will be extracted from the GP's patient record

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Acronym: CoDiaM

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 30, 2021
Registry last updated
Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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