NCT05897528

Brief Summary

The Coronavirus Disease of 2019 (COVID-19) pandemic has caused an international healthcare crisis and produced a large healthcare burden. Diabetes mellitus is a common disease that can be controlled via pharmacologic agents; however, many patients have poor glycemic control, leading to disease-related complications. Diabetes mellitus has been reported in the literature to be associated with increasing morbidity and mortality in COVID-19 patients, and some hypothesize that this is due to insulin dysregulation propagating a pro-inflammatory state. The investigators aim to contribute to the growing body of literature that assesses the associations between glucose homeostasis and COVID-19 disease severity and mortality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
589

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

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

October 14, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
Last Updated

June 9, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

May 24, 2023

Last Update Submit

June 7, 2023

Conditions

COVID-19Diabetes MellitusCOVID-19 PneumoniaCOVID-19 Respiratory Infection

Outcome Measures

Primary Outcomes (3)

  • Length of hospital stay

    The time spent hospitalized in days.

    Total time frame was 360 days

  • Length of time spent intubated on a ventilator

    The time spent intubated on a ventilator in days.

    30 days

  • Hospital Mortality

    Survival within the first 30 days

    30 days

Study Arms (2)

Diabetes Mellitus Positive Group

All patient that have a diagnosis of diabetes mellitus and COVID-19 Diagnosis

Other: No Intervention

Diabetes Mellitus Negative Group

All patient that do not have a diagnosis of diabetes mellitus but do have a diagnosis of COVID-19.

Other: No Intervention

Interventions

No InterventionOTHER

Difference in outcomes in patients with COVID-19 diagnosis and diabetes mellitus groups

Diabetes Mellitus Negative GroupDiabetes Mellitus Positive Group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

To evaluate diabetes mellitus and the associations with COVID-19 disease severity in patients older than 18 years of age.

You may qualify if:

  • At least 18 years of age
  • COVID-19 confirmed by laboratory testing (ICD10 U07.1)
  • Pneumonia due to COVID-19 (ICD10 J12.82)
  • Diagnosis of Diabetes Mellitus

You may not qualify if:

  • All patients under the age of 18
  • COVID in pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arrowhead Regional Medical Center

Colton, California, 92324, United States

Location

Related Publications (4)

  • Kumar A, Arora A, Sharma P, Anikhindi SA, Bansal N, Singla V, Khare S, Srivastava A. Is diabetes mellitus associated with mortality and severity of COVID-19? A meta-analysis. Diabetes Metab Syndr. 2020 Jul-Aug;14(4):535-545. doi: 10.1016/j.dsx.2020.04.044. Epub 2020 May 6.

    PMID: 32408118BACKGROUND

  • Espinosa OA, Zanetti ADS, Antunes EF, Longhi FG, Matos TA, Battaglini PF. Prevalence of comorbidities in patients and mortality cases affected by SARS-CoV2: a systematic review and meta-analysis. Rev Inst Med Trop Sao Paulo. 2020 Jun 22;62:e43. doi: 10.1590/S1678-9946202062043. eCollection 2020.

    PMID: 32578683BACKGROUND

  • Fox T, Ruddiman K, Lo KB, Peterson E, DeJoy R 3rd, Salacup G, Pelayo J, Bhargav R, Gul F, Albano J, Azmaiparashvili Z, Anastasopoulou C, Patarroyo-Aponte G. The relationship between diabetes and clinical outcomes in COVID-19: a single-center retrospective analysis. Acta Diabetol. 2021 Jan;58(1):33-38. doi: 10.1007/s00592-020-01592-8. Epub 2020 Aug 17.

    PMID: 32804317BACKGROUND

  • Apicella M, Campopiano MC, Mantuano M, Mazoni L, Coppelli A, Del Prato S. COVID-19 in people with diabetes: understanding the reasons for worse outcomes. Lancet Diabetes Endocrinol. 2020 Sep;8(9):782-792. doi: 10.1016/S2213-8587(20)30238-2. Epub 2020 Jul 17.

    PMID: 32687793BACKGROUND

MeSH Terms

Conditions

COVID-19Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Alexander Phan, MD

    Arrowhead Regional Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2023

First Posted

June 9, 2023

Study Start

October 14, 2021

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

June 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)