NCT04573335

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,282

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

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

Study Start

First participant enrolled

June 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
Last Updated

October 5, 2020

Status Verified

September 1, 2020

Enrollment Period

1 month

First QC Date

September 29, 2020

Last Update Submit

September 30, 2020

Conditions

Keywords

COVID-19diabetes mellitustelesurvey

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    Death due to diabetes-related complications or otherwise

    during 3months of lockdown

Secondary Outcomes (1)

  • COVID-19 illness

    During 3months of lockdown

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Type 1 and type 2 diabetic patients registered with Diabetes Management Centre, Services hospital, Lahore, Pakistan.

You may not qualify if:

  • Patients lacking telephonic contact or with invalid contact numbers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Services Hospital

Lahore, Punjab Province, 540000, Pakistan

Location

MeSH Terms

Conditions

Diabetes MellitusCOVID-19Social Isolation

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesSocial BehaviorBehavior

Study Officials

  • Saira Burney, MB;FRCP (Edin)

    SIMS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 29, 2020

First Posted

October 5, 2020

Study Start

June 1, 2020

Primary Completion

July 15, 2020

Study Completion

July 30, 2020

Last Updated

October 5, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations