Type 1 Diabetes Mellitus Clinical Trial
Official title:
Development and Efficacy of Individualized Professional Education Based on New Glucose Management Devices in Patients With Type 1 Diabetes Mellitus
Continuous glucose monitoring (CGM) and insulin pump, a new medical device, have been proved
and highly recommended in the treatment of type 1 diabetes patients worldwide, and related
technology development and market are growing rapidly.
In order to maximize the medical and socioeconomic effects of the latest blood glucose
devices including CGM and insulin pump, structured education is necessary. In this study, we
will develop patient-oriented structured education for patients with type 1 diabetes mellitus
when applying CGM, and we will assess the efficacy of this education protocol for patients
with type 1 diabetes using CGM.
In 50 patients with type 1 diabetes with over 7% of glycated hemoglobin, whose blood glucose
level is not well controlled, and who are undergoing multiple daily insulin injection therapy
or insulin pump therapy, continuous glucose monitoring (CGM) is applied to obtain basal
continuous glucose levels for 1 week (window period of 2 week).
These 50 patients are 1:1 randomly assigned to 2 groups including control group and
intervention group. Control group (n=25) applied CGM without structured education and after 3
months of applying CGM, continuous glucose data for 2 consecutive weeks and HbA1c level, and
other glycometabolic parameters are collected. As a sequential extension clinical trial,
those 25 patients in control group are provided structured education, followed by applying
CGM for 3 months. Continuous glucose levels for 2 consecutive weeks and HbA1c level, and
other glycometabolic parameters are collected.
In Intervention group (n=25), structured education program is provided for each patient from
the time of enrollment, followed by applying CGM for 3 months. Continuous glucose levels for
2 consecutive weeks and HbA1c level and other blood tests are performed after the 3 months.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04476472 -
Omnipod Horizon™ Automated Glucose Control System Preschool Cohort
|
N/A | |
| Completed |
NCT03635437 -
Evaluation of Safety and Diabetes Status Upon Oral Treatment With GABA in Patients With Longstanding Type-1 Diabetes
|
Phase 1/Phase 2 | |
| Completed |
NCT04909580 -
Decision Coaching for Youth and Parents Considering Insulin Delivery Methods for Type 1 Diabetes
|
N/A | |
| Active, not recruiting |
NCT00679042 -
Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol
|
Phase 3 | |
| Completed |
NCT03293082 -
Preschool CGM Use and Glucose Variability in Type 1 Diabetes
|
N/A | |
| Completed |
NCT04016662 -
Automated Insulin Delivery in Elderly With Type 1 Diabetes (AIDE T1D)
|
Phase 4 | |
| Completed |
NCT02527265 -
Afrezza Safety and Pharmacokinetics Study in Pediatric Patients
|
Phase 2 | |
| Completed |
NCT03738865 -
G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes
|
Phase 3 | |
| Completed |
NCT03240432 -
Wireless Innovation for Seniors With Diabetes Mellitus
|
N/A | |
| Completed |
NCT03168867 -
Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms)
|
N/A | |
| Completed |
NCT03674281 -
The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System
|
N/A | |
| Completed |
NCT03669770 -
Ultrasound Classification and Grading of Lipohypertrophy and Its Impact on Glucose Variability in Type 1 Diabetes
|
||
| Recruiting |
NCT03682640 -
Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes
|
Phase 2 | |
| Recruiting |
NCT04096794 -
Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research
|
||
| Completed |
NCT02882737 -
The Impact of Subcutaneous Glucagon Before, During and After Exercise a Study in Patients With Type 1 Diabetes Mellitus
|
N/A | |
| Recruiting |
NCT02745808 -
Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes
|
Phase 1 | |
| Withdrawn |
NCT02579148 -
Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes
|
Phase 1 | |
| Completed |
NCT02558491 -
Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM
|
N/A | |
| Completed |
NCT02596204 -
Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring
|
N/A | |
| Completed |
NCT02562313 -
A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®
|
Phase 1 |