Continuous Glucose Monitorization in Hospitalized Patient... | NCT05096858

Studies
Continuous Glucose Monitorization in Hospitalized Patients With COVID-19

NCT05096858

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status

Unknown status

Last Update Posted

Mar 8, 2024Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Diabetes Mellitus
Covid19

Interventions

Not provided

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Actual

Primary Completion Date

Jun 30, 2024Estimated

Completion Date

Jul 31, 2024Estimated

First Submitted Date

Sep 13, 2021

First Submission Date that Met QC Criteria

Oct 25, 2021

First Posted Date

Oct 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2024

Last Update Posted Date

Mar 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

DM2 is a major comorbidity of COVID-19. It has been observed that subjects with DM2 require more medical interventions, have a significantly higher mortality (7.8% versus 2.7%) and injuries of multiple organs that the individuals not diabetics.

In situations of glycemic variability, phenomena of oxidative stress and activation of protein kinase C can be initiated , through the release of pro-inflammatory cytosines , which could induce microvascular damage .Patients with diabetes and COVID-19 were shown to be more likely to develop serious or critical illness with more complications, and to have higher incidence rates of antibiotic therapy, non-invasive and invasive mechanical ventilation, and death (11.1% vs. 4.1%).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glucose variability	Percentage of time within the ADA recommended range	For up to two weeks, during hospitalization
Insulin use	Average daily UI of insulin per patient	For up two weeks, during hospitalization

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed COVID-19 pneumonia
Diabetes mellitus

Exclusion Criteria:

Less than 3 days of hospital care

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Adults living with diabetes and suffering from COVID19 pneumonia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ALFONSO GULIAS HERRERO	Contact	523123173679		alfonso.guliash@incmnsz.mx
ALHELY GAYTAN SANTILLAN	Contact			alhely.gaytans@incmnsz.mx

Overall Officials

Name	Affiliation	Role
ALFONSO GULIAS HERRERO	INCMNSZ	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institute of Medical Sciences and Nutrition Salvador Zubiran	Recruiting	Mexico City		14080	Mexico

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Mar 9, 2026
Reset	Mar 26, 2026

Submission Tracking

Estimated Results First Submitted Date

Mar 9, 2026

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 9, 2026			Mar 26, 2026

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D000086382	COVID-19

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided