Analysis of Related Risk Factors of Hypoglycemia Consciou... | NCT04971070

Studies
Analysis of Related Risk Factors of Hypoglycemia Consciousness Disorder

NCT04971070

Sponsor

Chongqing Renji Hospital, University of Chinese Academy of Sciences

Status

Completed

Last Update Posted

Feb 8, 2023Actual

Enrollment

292Actual

Phase

Not provided

Conditions

Hypoglycemia

Interventions

Observation and follow-up

Countries

China

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 25, 2021Actual

Primary Completion Date

Feb 20, 2022Actual

Completion Date

Jan 15, 2023Actual

First Submitted Date

Jun 23, 2021

First Submission Date that Met QC Criteria

Jul 18, 2021

First Posted Date

Jul 21, 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

Feb 5, 2023

Last Update Posted Date

Feb 8, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Objective to explore the high risk factors and inducements of consciousness disorder in patients with hypoglycemia, and to conduct a retrospective study.

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

292Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypoglycemic disturbance group			Other: Observation and follow-up
Hypoglycemia was not a disorder of consciousness group			Other: Observation and follow-up

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation and follow-up	Other	Observation and follow-up study	Hypoglycemia was not a disorder of consciousness group Hypoglycemic disturbance group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Analysis of risk factors of hypoglycemia with disturbance of consciousness	Analysis of risk factors of hypoglycemia with disturbance of consciousness	2021-2011

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Symptoms of hypoglycemia such as palpitation, sweating and fatigue were found at the time of treatment. At the same time, the blood glucose of non-diabetic patients was less than 2.8mmol/L, and the blood glucose of diabetic patients was less than 3.9mmol/L

Exclusion Criteria:

Exclusion criteria: Although there were hypoglycemia symptoms at the time of treatment, the blood glucose of non-diabetic patients was more than 2.8mmol/L, and the blood glucose of diabetic patients was more than 3.9mmol/L.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Through retrospective control study, this study analyzed the high-risk factors and predisposing factors of hypoglycemia patients, laid a certain foundation for improving the diagnosis and treatment level of hypoglycemia consciousness disorder, and provided a certain scientific basis for further exploring the mechanism of hypoglycemia consciousness disorder

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chongqing Renji Hospital, University of Chinese Academy of Sciences		Chongqing	Chongqing Municipality	400062	China

Condition Browse Module

MeSH Terms

ID	Term
D007003	Hypoglycemia

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D008722	Methods
D008919	Investigative Techniques