Type 1 Diabetes Mellitus Clinical Trial
Official title:
Efficacy of Continuous Glucose Monitoring in Subjects With Type 1 Diabetes Mellitus on Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) Therapy
The purpose of this study is to evaluate the effectiveness of the Continuous Glucose
Monitoring System (DexCom™ SEVEN PLUS®) and to evaluate the impact of CGM on glycemic
control when worn for up to 6-months by subjects 18 to 70 years-old with Type 1 diabetes
mellitus on MDI or CSII therapy.
The primary objective of this study is to demonstrate no statistically significant
differences between MDI and CSII subjects in terms of A1C change at 6 months as compared to
baseline. A secondary objective is to evaluate time spent outside of the euglycemic region
(70 to 180 mg/dL) from the baseline (blinded month) to the conclusion of 6 month follow-up.
Safety data of the SEVEN PLUS System will also be collected and safety will be characterized
by the incidence of Adverse Device Effects, Serious Adverse Device Events, and Unanticipated
Adverse Device Effects experienced by study participants.
n/a
Observational Model: Cohort, Time Perspective: Prospective
| 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 | |
| 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 | |
| Withdrawn |
NCT02579148 -
Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes
|
Phase 1 | |
| Completed |
NCT02562313 -
A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®
|
Phase 1 |