NCT04821921

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,503

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

April 9, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

1.4 years

First QC Date

March 29, 2021

Last Update Submit

November 3, 2022

Conditions

Type 2 DiabetesType 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c (HbA1c)

    Data on outcome will be extracted from the GP's patient record

    01.01.2019 to 31.12.2021

Study Arms (1)

Patients with diabetes mellitus

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

Other: No intervention

Interventions

No interventionOTHER

Care as usual

Patients with diabetes mellitus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hamburg, 20246, Germany

Location

Related Publications (2)

  • 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.

    PMID: 38642263DERIVED

  • 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.

    PMID: 38249413DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Ingmar Schäfer, Dr. phil.

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2021

First Posted

March 30, 2021

Study Start

April 9, 2021

Primary Completion

September 15, 2022

Study Completion

September 15, 2022

Last Updated

November 4, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Individual participant data are available from the principal investigator on reasonable request.

Locations

DE(1)