NCT02885909

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 26, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 7, 2020

Status Verified

December 1, 2019

Enrollment Period

6.3 years

First QC Date

August 26, 2016

Last Update Submit

January 4, 2020

Conditions

HYPERGLYCEMIA

Keywords

type 2 diabetesinpatientglucose controlcontinue glucose monitor

Outcome Measures

Primary Outcomes (1)

  • Glucose target

    The ratio of glucose less than 180 mg/dl

    6 days

Secondary Outcomes (5)

  • Fasting glucose target

    6 days

  • Hypoglycemia

    times

  • Vascular Cell Adhesion Molecule 1 (VCAM-1)

    6 days

  • Brain-Derived Neurotrophic Factor (BDNF)

    6 days

  • Orexin-A

    6 days

Study Arms (3)

Insulin protocal with CGM

ACTIVE COMPARATOR

Insulin protocal with continue glucose monitor

Device: CONTINUE GLUCOSE MONITORProcedure: Insulin protocal

Insulin protocal

ACTIVE COMPARATOR

Insulin protocal with convential glucose monitor

Procedure: Insulin protocal

Convential treatment

NO INTERVENTION

Convential insulin treatment and glucose monitor

Interventions

CONTINUE GLUCOSE MONITORDEVICE

Continue glucose monitor

Insulin protocal with CGM
Insulin protocalPROCEDURE

Using insulin protocal based on glucose monitor

Insulin protocalInsulin protocal with CGM

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetic inpatient
  • Fasting glucose \>140 mg/dl or random glucose \>180 mg/dl

You may not qualify if:

  • incooperative for glucose monitor
  • refusal of insulin
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

RECRUITING

MeSH Terms

Conditions

HyperglycemiaDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Study Officials

  • I-Te Lee, MD,PhD

    Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

I-Te Lee, MD, PhD

CONTACT

+886-4-23592525itlee@vghtc.gov.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2016

First Posted

September 1, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2022

Study Completion

December 1, 2025

Last Updated

January 7, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

No plan to make individual participant data (IPD) available

Locations

TW(1)