HYPERGLYCEMIAPhase 4NCT02885909
Inpatient Blood Glucose Control in Taichung Veterans General Hospital
A Phase 4 study testing CONTINUE GLUCOSE MONITOR and Insulin protocal in people with HYPERGLYCEMIA, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
This study will be conducted in the ward of Taichung Veterans General Hospital. The patient with hyperglycemia in hospitalization will be enrolled by glucose management team. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- HYPERGLYCEMIA
- What is being tested?
- CONTINUE GLUCOSE MONITOR and Insulin protocal
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2016to Dec 2025
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetic inpatient
- Fasting glucose >140 mg/dl or random glucose >180 mg/dl
Who cannot join
- incooperative for glucose monitor
- refusal of insulin
- pregnancy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, 40705
About this study
Official title: The Effects of Glucose Control and Monitor on Inflammation in the Hospitalized Patients With Hyperglycemia
This study will be conducted in the ward of Taichung Veterans General Hospital. The patient with hyperglycemia in hospitalization will be enrolled by glucose management team.
Read the detailed description
This study will be conducted in the ward of Taichung Veterans General Hospital. The type 2 diabetic patient with hyperglycemia in hospitalization are candidates. The glucose will be controlled using the insulin protocal based on the glucose monitor systems. We will assess the effects of insulin protocal and glucose monitor system on the inpatient with hyperglycemia.
- Conditions
- HYPERGLYCEMIA
- Being tested
- CONTINUE GLUCOSE MONITOR, Insulin protocal
- Keywords
- type 2 diabetes, inpatient, glucose control, continue glucose monitor
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONTINUE GLUCOSE MONITORDevice
Continue glucose monitor
Insulin protocalProcedure or surgery
Using insulin protocal based on glucose monitor
| Study group | Role | What they receive |
|---|---|---|
| Insulin protocal with CGM | Active comparator | Insulin protocal with continue glucose monitor Receives: Device: CONTINUE GLUCOSE MONITOR; Procedure: Insulin protocal |
| Insulin protocal | Active comparator | Insulin protocal with convential glucose monitor Receives: Procedure: Insulin protocal |
| Convential treatment | No intervention | Convential insulin treatment and glucose monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose target
The ratio of glucose less than 180 mg/dl
Measured: 6 days
Secondary outcomes (5)
Fasting glucose target
the ratio of fasting glucose less than 140 mg/dl
Measured: 6 days
Hypoglycemia
symptoms or less than 70
Measured: times
Vascular Cell Adhesion Molecule 1 (VCAM-1)
Inflammation
Measured: 6 days
Brain-Derived Neurotrophic Factor (BDNF)
Psychological assessment
Measured: 6 days
Orexin-A
Psychological assessment
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2022 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HYPERGLYCEMIAStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- I-Te Lee, MD,PhD, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885909
- Sponsor's protocol ID
- CF16199B
- Status last verified
- Dec 2019
- First submitted
- 26 Aug 2016
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to make individual participant data (IPD) available
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Glucose Control and Monitor on Inflammation in the Hospitalized Patients With Hyperglycemia
- ClinicalTrials.gov ID
- NCT02885909
- Acronym / sponsor ID
- CF16199B
- Conditions
- HYPERGLYCEMIA
- Keywords
- type 2 diabetes, inpatient, glucose control, continue glucose monitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Sep 2016 (estimated)
- 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.
This study will be conducted in the ward of Taichung Veterans General Hospital. The patient with hyperglycemia in hospitalization will be enrolled by glucose management team.
Detailed description
This study will be conducted in the ward of Taichung Veterans General Hospital. The type 2 diabetic patient with hyperglycemia in hospitalization are candidates. The glucose will be controlled using the insulin protocal based on the glucose monitor systems. We will assess the effects of insulin protocal and glucose monitor system on the inpatient with hyperglycemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Insulin protocal with CGM | Active comparator | Device: CONTINUE GLUCOSE MONITOR, Procedure: Insulin protocalInsulin protocal with continue glucose monitor |
| Insulin protocal | Active comparator | Procedure: Insulin protocalInsulin protocal with convential glucose monitor |
| Convential treatment | No intervention | –Convential insulin treatment and glucose monitor |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetic inpatient
- Fasting glucose >140 mg/dl or random glucose >180 mg/dl
Key exclusion criteria (3 listed)
- incooperative for glucose monitor
- refusal of insulin
- pregnancy
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 |
|---|---|---|
| CONTINUE GLUCOSE MONITORContinue glucose monitor | Device | Insulin protocal with CGM |
| Insulin protocalUsing insulin protocal based on glucose monitor | Procedure or surgery | Insulin protocal, Insulin protocal with CGM |
Primary outcome
Glucose target
Time frame: 6 days
The ratio of glucose less than 180 mg/dl
5 secondary outcomes
Fasting glucose target
Time frame: 6 days
Hypoglycemia
Time frame: times
Vascular Cell Adhesion Molecule 1 (VCAM-1)
Time frame: 6 days
Brain-Derived Neurotrophic Factor (BDNF)
Time frame: 6 days
Orexin-A
Time frame: 6 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Individual participant dataSharing planned: No. No plan to make individual participant data (IPD) available
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Recruiting
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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.
I-Te Lee, MD,PhD principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CONTINUE GLUCOSE MONITOR and Insulin protocal in people with HYPERGLYCEMIA, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Jan 2020. 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 Taiwan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact I-Te Lee, MD, PhD (+886-4-23592525 ext. 4006, itlee@vghtc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose target (time frame: 6 days). 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 7 Jan 2020.