HypoglycemiaNCT04971070
Analysis of Related Risk Factors of Hypoglycemia Consciousness Disorder
An observational study of Hypoglycemia, run by Chongqing Renji Hospital, University of Chinese Academy of Sciences at 1 site in China.
Trial summary
Objective to explore the high risk factors and inducements of consciousness disorder in patients with hypoglycemia, and to conduct a retrospective study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypoglycemia
- What is being tested?
- Observation and follow-up
- How many people
- 292 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2021to 15 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older 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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Chongqing Renji Hospital, University of Chinese Academy of Sciences
Chongqing, Chongqing Municipality, 400062
About this study
Objective to explore the high risk factors and inducements of consciousness disorder in patients with hypoglycemia, and to conduct a retrospective study.
- Conditions
- Hypoglycemia
- Being tested
- Observation and follow-up
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation and follow-upOther
Observation and follow-up study
| Study group | Role | What they receive |
|---|---|---|
| Hypoglycemic disturbance group | Not described Receives: Other: Observation and follow-up | |
| Hypoglycemia was not a disorder of consciousness group | Not described Receives: Other: Observation and follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of risk factors of hypoglycemia with disturbance of consciousness
Analysis of risk factors of hypoglycemia with disturbance of consciousness
Measured: 2021-2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start25 Jul 2021
- Primary completion20 Feb 2022
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Renji Hospital, University of Chinese Academy of Sciences
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971070
- Sponsor's protocol ID
- 31921003
- Status last verified
- Jun 2021
- First submitted
- 23 Jun 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Related Risk Factors of Hypoglycemia Consciousness Disorder
- ClinicalTrials.gov ID
- NCT04971070
- Acronym / sponsor ID
- 31921003
- Conditions
- Hypoglycemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Chongqing Renji Hospital, University of Chinese Academy of SciencesOther government
- Study start
- 25 Jul 2021 (actual)
- Primary completion
- 20 Feb 2022 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective to explore the high risk factors and inducements of consciousness disorder in patients with hypoglycemia, and to conduct a retrospective study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypoglycemic disturbance group | – | Other: Observation and follow-up |
| Hypoglycemia was not a disorder of consciousness group | – | Other: Observation and follow-up |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation and follow-upObservation and follow-up study | Other | Hypoglycemia was not a disorder of consciousness group, Hypoglycemic disturbance group |
Primary outcome
Analysis of risk factors of hypoglycemia with disturbance of consciousness
Time frame: 2021-2011
Analysis of risk factors of hypoglycemia with disturbance of consciousness
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoglycemia, run by Chongqing Renji Hospital, University of Chinese Academy of Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of risk factors of hypoglycemia with disturbance of consciousness (time frame: 2021-2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.