The Impact of the COVID-19 Pandemic on Diabetes Management

Completed

• Conditions: Type 2 Diabetes; Type 1 Diabetes Mellitus
• Interventions: Other: No intervention

• Registration Number: NCT04821921
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-03-30
• Study Start: 2021-04-09
• Primary Completion: 2022-09-15
• Study Completion: 2022-09-15
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1503

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with diabetes mellitus	No intervention	Approximately 750 patients with diabetes mellitus from 3 GP practices specialized on diabetes treatment

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c (HbA1c)	01.01.2019 to 31.12.2021	Data on outcome will be extracted from the GP's patient record

Trial Locations

Locations (1)

Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany