The Impact of the COVID-19 Pandemic on Diabetes Management

Type 2 Diabetes Clinical Trial

— CoDiaM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04821921
• Other study ID #: IPA-2021-01
• Status: Completed
• Start date: April 9, 2021
• Est. completion date: September 15, 2022

Study information

• Verified date: November 2022
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1503
• Est. completion date: September 15, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus
• Type 2 Diabetes

Intervention

Other:
• No intervention
Care as usual

Locations

Country	Name	City	State
Germany	Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c (HbA1c)	Data on outcome will be extracted from the GP's patient record	01.01.2019 to 31.12.2021