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

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ClinicalTrials.gov Identifier: NCT04821921
Recruitment Status : Recruiting
First Posted : March 30, 2021
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. phil. Ingmar Schäfer, Universitätsklinikum Hamburg-Eppendorf

Study Description
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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.

Condition or disease Intervention/treatment
Type 2 Diabetes Type 1 Diabetes Mellitus 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 Design
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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Impact of the COVID-19 Pandemic on Diabetes Management (CoDiaM)
Actual Study Start Date : April 9, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04821921


Contacts
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Contact: Ingmar Schäfer, Dr. phil. +49-40-7410-52760 in.schaefer@uke.de

Locations
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Germany
Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Ingmar Schäfer, Dr. phil.    +49-40-7410-52760    in.schaefer@uke.de   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
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Principal Investigator: Ingmar Schäfer, Dr. phil. Universitätsklinikum Hamburg-Eppendorf
More Information
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Responsible Party: Dr. phil. Ingmar Schäfer, Principal Investigator, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT04821921    
Other Study ID Numbers: IPA-2021-01
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data are available from the principal investigator on reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Respiratory Tract Infections
Infections
 Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases