Type 2 DiabetesCoDiaMNCT04821921
The Impact of the COVID-19 Pandemic on Diabetes Management
An observational study of Type 2 Diabetes and Type 1 Diabetes Mellitus, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Type 1 Diabetes Mellitus
- How many people
- 1,503 participants
- Where
- 1 siteGermany
- Study dates
- 9 Apr 2021to 15 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf
Hamburg, 20246
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes, Type 1 Diabetes Mellitus
- Being tested
- No intervention
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Care as usual
| Study group | Role | What they receive |
|---|---|---|
| Patients with diabetes mellitus | Approximately 750 patients with diabetes mellitus from 3 GP practices specialized on diabetes treatment Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c (HbA1c)
Data on outcome will be extracted from the GP's patient record
Measured: 01.01.2019 to 31.12.2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start9 Apr 2021
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,503 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. phil. Ingmar Schäfer, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Ingmar Schäfer, Dr. phil., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821921
- Sponsor's protocol ID
- IPA-2021-01
- Acronym
- CoDiaM
- Status last verified
- Nov 2022
- First submitted
- 29 Mar 2021
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are available from the principal investigator on reasonable request.
Publications
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.
PubMed 38642263Schafer 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.
PubMed 38249413
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the COVID-19 Pandemic on Diabetes Management (CoDiaM)
- ClinicalTrials.gov ID
- NCT04821921
- Acronym / sponsor ID
- CoDiaM / IPA-2021-01
- Conditions
- Type 2 Diabetes, Type 1 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,503 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with diabetes mellitus | – | Other: No interventionApproximately 750 patients with diabetes mellitus from 3 GP practices specialized on diabetes treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionCare as usual | Other | Patients with diabetes mellitus |
Primary outcome
Hemoglobin A1c (HbA1c)
Time frame: 01.01.2019 to 31.12.2021
Data on outcome will be extracted from the GP's patient record
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Derived from this study: PubMed 38642263Tajdar 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.
- Derived from this study: PubMed 38249413Schafer 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.
- Individual participant dataSharing planned: No. Individual participant data are available from the principal investigator on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingmar Schäfer, Dr. phil. principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Type 1 Diabetes Mellitus, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (HbA1c) (time frame: 01.01.2019 to 31.12.2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04821921, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.