DiabetesNCT04573335
Diabetes Outcomes in COVID-19 Pandemic
An observational study of Diabetes and Covid19, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
Trial summary
Diabetes management and follow-up has become a challenge during the COVID-19 pandemic. Nation-wide lockdowns and social distancing measures adopted in an attempt to break the chain of COVID-19 transmission have significantly disrupted routine care and follow-up of diabetes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes, Covid19, Isolation, Social
- How many people
- 1,282 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2020to 30 Jul 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic subjects already registered with and on regular follow-up with DMC and had visited DMC for consultation more than once between 1st August 2019 to 15th March 2020.
Who may be able to join
- Type 1 and type 2 diabetic patients registered with Diabetes Management Centre, Services hospital, Lahore, Pakistan.
Who cannot join
- Patients lacking telephonic contact or with invalid contact numbers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health-related Outcomes and Behaviour Changes in a Cohort of Diabetic Population During COVID-19 Pandemic: Results of a Telephonic Survey
Diabetes management and follow-up has become a challenge during the COVID-19 pandemic. Nation-wide lockdowns and social distancing measures adopted in an attempt to break the chain of COVID-19 transmission have significantly disrupted routine care and follow-up of diabetes. In the health sector, especially in low-income countries such as Pakistan, there has been a shift of resources and staff reassignment from stable chronic illnesses to support COVID-19 pandemic. Disruption of routine outpatient health services and travel restrictions increase the risk of worsening diabetes control and diabetes-related health outcomes. Additionally, social isolation amidst an atmosphere of fear and uncertainty contributes to stress further affecting glycaemic control.
Read the detailed description
An observational cross-sectional study was conducted using telephone interview method in Diabetes Management Centre (DMC), Services hospital, Lahore. The study participants were 1282 diabetic patients selected randomly from electronic medical record (EMR) database of the Centre. A structured questionnaire was used to evaluate parameters which included patients' demographic information; diabetes self-care and general health profile; COVID-related questions and its impact on quality of life (QoL); financial and social support issues.
- Conditions
- Diabetes, Covid19, Isolation, Social
- Keywords
- COVID-19, diabetes mellitus, telesurvey
- Medical subject headings
- Diabetes Mellitus, COVID-19, Social Isolation
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Death due to diabetes-related complications or otherwise
Measured: during 3months of lockdown
Secondary outcomes (1)
COVID-19 illness
%age of participants with one or more symptoms of fever, sore throat, cough, dyspnoea
Measured: During 3months of lockdown
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Jun 2020
- Primary completion15 Jul 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Institute of Medical Sciences, Pakistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Saira Burney, Services Institute of Medical Sciences, Pakistan
- Investigators
- Saira Burney, MB;FRCP (Edin), Principal investigator, SIMS SIUT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573335
- Sponsor's protocol ID
- 16102019
- Status last verified
- Sep 2020
- First submitted
- 29 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-related Outcomes and Behaviour Changes in a Cohort of Diabetic Population During COVID-19 Pandemic: Results of a Telephonic Survey
- ClinicalTrials.gov ID
- NCT04573335
- Acronym / sponsor ID
- 16102019
- Conditions
- Diabetes, Covid19, Isolation, Social
- Keywords
- COVID-19, diabetes mellitus, telesurvey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,282 participants (actual)
- Lead sponsor
- Services Institute of Medical Sciences, PakistanOther government
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 5 Oct 2020 (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.
Diabetes management and follow-up has become a challenge during the COVID-19 pandemic. Nation-wide lockdowns and social distancing measures adopted in an attempt to break the chain of COVID-19 transmission have significantly disrupted routine care and follow-up of diabetes. In the health sector, especially in low-income countries such as Pakistan, there has been a shift of resources and staff reassignment from stable chronic illnesses to support COVID-19 pandemic. Disruption of routine outpatient health services and travel restrictions increase the risk of worsening diabetes control and diabetes-related health outcomes. Additionally, social isolation amidst an atmosphere of fear and uncertainty contributes to stress further affecting glycaemic control.
Detailed description
An observational cross-sectional study was conducted using telephone interview method in Diabetes Management Centre (DMC), Services hospital, Lahore. The study participants were 1282 diabetic patients selected randomly from electronic medical record (EMR) database of the Centre. A structured questionnaire was used to evaluate parameters which included patients' demographic information; diabetes self-care and general health profile; COVID-related questions and its impact on quality of life (QoL); financial and social support issues.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic subjects already registered with and on regular follow-up with DMC and had visited DMC for consultation more than once between 1st August 2019 to 15th March 2020.
Key inclusion criteria (1 listed)
- Type 1 and type 2 diabetic patients registered with Diabetes Management Centre, Services hospital, Lahore, Pakistan.
Key exclusion criteria (1 listed)
- Patients lacking telephonic contact or with invalid contact numbers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality
Time frame: during 3months of lockdown
Death due to diabetes-related complications or otherwise
1 secondary outcome
COVID-19 illness
Time frame: During 3months of lockdown
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 5 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Saira Burney, MB;FRCP (Edin) principal investigator
SIMS SIUT
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 Diabetes and Covid19, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
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 1 inclusion and 1 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 5 Oct 2020. 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 Pakistan. 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?
All-cause mortality (time frame: during 3months of lockdown). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2020.