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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Type 1 Diabetes Mellitus
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Actual): 1503

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study is located in Hamburg, Germany. Patients from three GP practices specialized on diabetes treatment in Hamburg will be included. In each practice, eligible patients with diabetes type 1 and 2 will receive patient information, consent form and questionnaire by mail. After written informed consent and after the questionnaires have been returned, data from patient records in the practices will be extracted. The investigators estimated that approximately 3000 patients will be eligible to be contacted. From pretest and experience with similar studies the investigators anticipated a response rate of 25% (=750 patients).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with diabetes mellitus; Approximately 750 patients with diabetes mellitus from 3 GP practices specialized on diabetes treatment	Other: No intervention; Care as usual

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Ingmar Schäfer, Dr. phil., Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2021
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): September 15, 2022

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): March 30, 2021

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Autoimmune Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Endocrine System Diseases; COVID-19; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: IPA-2021-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data are available from the principal investigator on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No