The Impact of the COVID-19 Pandemic on Diabetes Management

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

Sponsors

Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Source Universitätsklinikum Hamburg-Eppendorf
Brief Summary

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

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.

Overall Status Not yet recruiting
Start Date April 15, 2021
Completion Date June 30, 2022
Primary Completion Date March 31, 2022
Study Type Observational
Primary Outcome
Measure Time Frame
Hemoglobin A1c (HbA1c) 01.01.2019 to 31.12.2021
Enrollment 750
Condition
Intervention

Intervention Type: Other

Intervention Name: No intervention

Description: Care as usual

Arm Group Label: Patients with diabetes mellitus

Eligibility

Sampling Method: Probability Sample

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Verification Date

March 2021

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Universitätsklinikum Hamburg-Eppendorf

Investigator Full Name: Dr. phil. Ingmar Schäfer

Investigator Title: Dr. phil. Ingmar Schäfer

Has Expanded Access No
Condition Browse
Arm Group

Label: Patients with diabetes mellitus

Description: Approximately 750 patients with diabetes mellitus from 3 GP practices specialized on diabetes treatment

Acronym CoDiaM
Patient Data No
Study Design Info

Observational Model: Other

Time Perspective: Prospective

Source: ClinicalTrials.gov

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