- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04573335
Diabetes Outcomes in COVID-19 Pandemic
September 30, 2020 updated by: Dr. Saira Burney, Services Institute of Medical Sciences, Pakistan
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
1282
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
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Lahore, Punjab, Pakistan, 540000
- Services Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- Type 1 and type 2 diabetic patients registered with Diabetes Management Centre, Services hospital, Lahore, Pakistan.
Exclusion Criteria:
- Patients lacking telephonic contact or with invalid contact numbers.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause mortality
Time Frame: during 3months of lockdown
|
Death due to diabetes-related complications or otherwise
|
during 3months of lockdown
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COVID-19 illness
Time Frame: During 3months of lockdown
|
%age of participants with one or more symptoms of fever, sore throat, cough, dyspnoea
|
During 3months of lockdown
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Saira Burney, MB;FRCP (Edin), SIMS
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2020
Primary Completion (Actual)
July 15, 2020
Study Completion (Actual)
July 30, 2020
Study Registration Dates
First Submitted
September 29, 2020
First Submitted That Met QC Criteria
September 30, 2020
First Posted (Actual)
October 5, 2020
Study Record Updates
Last Update Posted (Actual)
October 5, 2020
Last Update Submitted That Met QC Criteria
September 30, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16102019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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