Diabetes Outcomes in COVID-19 Pandemic

• Sponsor: Services Institute of Medical Sciences, Pakistan (Other)
• Overall Status: Completed
• CT.gov ID: NCT04573335
• Collaborator: (none)
• Enrollment: 1,282
• Location: 1
• Actual Duration (Months): 1.9
• Patients Per Site Per Month: 661.4

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Covid19; Isolation, Social

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

• Study Type: Observational
• Actual Enrollment: 1282 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Health-related Outcomes and Behaviour Changes in a Cohort of Diabetic Population During COVID-19 Pandemic: Results of a Telephonic Survey
• Actual Study Start Date: Jun 1, 2020
• Actual Primary Completion Date: Jul 15, 2020
• Actual Study Completion Date: Jul 30, 2020

Outcome Measures

Primary Outcome Measures

1. All-cause mortality [during 3months of lockdown]

   Death due to diabetes-related complications or otherwise

Secondary Outcome Measures

1. COVID-19 illness [During 3months of lockdown]

   %age of participants with one or more symptoms of fever, sore throat, cough, dyspnoea

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Services Hospital	Lahore	Punjab	Pakistan	540000

Sponsors and Collaborators

• Services Institute of Medical Sciences, Pakistan

Investigators

• Principal Investigator: Saira Burney, MB;FRCP (Edin), SIMS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Saira Burney, Doctor, Services Institute of Medical Sciences, Pakistan
• ClinicalTrials.gov Identifier: NCT04573335
• Other Study ID Numbers: 16102019
• First Posted: Oct 5, 2020
• Last Update Posted: Oct 5, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr. Saira Burney, Doctor, Services Institute of Medical Sciences, Pakistan: COVID-19; diabetes mellitus; telesurvey
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Oct 5, 2020