The Impact of the COVID-19 Pandemic on Diabetes Management

NCT ID: NCT04821921

Last Updated: 2022-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1503 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-09

Study Completion Date

2022-09-15

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Type 1 Diabetes Mellitus

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with diabetes mellitus

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

No intervention

Intervention Type OTHER

Care as usual

Interventions

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No intervention

Care as usual

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Dr. phil. Ingmar Schäfer

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ingmar Schäfer, Dr. phil.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

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Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Countries

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Germany

References

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Tajdar D, Luhmann D, Walther L, Bittner L, Scherer M, Schafer I. Effects of Two COVID-19 Lockdowns on HbA1c Levels in Patients with Type 1 Diabetes and Associations with Digital Treatment, Health Literacy, and Diabetes Self-Management: A Multicenter, Observational Cohort Study Over 3 Years. Diabetes Ther. 2024 Jun;15(6):1375-1388. doi: 10.1007/s13300-024-01574-x. Epub 2024 Apr 20.

Reference Type DERIVED
PMID: 38642263 (View on PubMed)

Schafer I, Tajdar D, Walther L, Bittner L, Luhmann D, Scherer M. Impact of two COVID-19 lockdowns on HbA1c levels in patients with type 2 diabetes and associations with patient characteristics: a multicentre, observational cohort study over three years. Front Public Health. 2024 Jan 5;11:1272769. doi: 10.3389/fpubh.2023.1272769. eCollection 2023.

Reference Type DERIVED
PMID: 38249413 (View on PubMed)

Other Identifiers

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IPA-2021-01

Identifier Type: -

Identifier Source: org_study_id

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