Type 1 Diabetes Clinical Trial
Official title:
MD-Logic Artificial Pancreas for Automatic Type 1 Diabetes Meals Management
The MDLAP (MD-Logic Artificial Pancreas)system is as an automatic system to regulate glucose
levels by delivery of insulin operable in clinical trial settings. The safety of the system
was proved in previous inpatient and outpatient trials in large number of patients. In the
current study we aim to optimize post-prandial closed-loop glycemic control by developing an
automated MD-bolus calculator and to evaluate its safety and efficacy in controlling
postprandial blood glucose when used together with the MD-Logic artificial pancreas system
in type 1 diabetes patients.
The study will consist of a pilot study with two segments and a main study segment. The aim
of each segment is detailed below:
1. Pilot Study - Segment 1 - Hybrid meal bolus ratio The aim of this segment is to
evaluate the efficacy and safety of different pre-meal bolus dosing compared to full
closed-loop operation with no meal announcement.
2. Pilot Study - Segment 2 - Insulin dosing during meal In this segment we would like to
test the optimal distribution of insulin delivery during the meal.
3. Main study - Segment 3 - Automatic bolus calculator In this main segment of the study
we will use the results and conclusions from the previous two pilot segments to develop
the MD-Bolus Calculator for closed-loop control use. The safety and efficacy of this
automated insulin bolus calculator will be tested in a randomized cross-over study that
will compare postprandial glycemic control under MDLAP with and without the use of the
MD-Bolus Calculator.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05653518 -
Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
|
N/A | |
| Enrolling by invitation |
NCT05515939 -
Evaluating the InPen in Pediatric Type 1 Diabetes
|
||
| Completed |
NCT05109520 -
Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
|
||
| Recruiting |
NCT04016987 -
Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes
|
N/A | |
| Active, not recruiting |
NCT04190368 -
Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes
|
N/A | |
| Recruiting |
NCT05413005 -
Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus
|
Early Phase 1 | |
| Active, not recruiting |
NCT04668612 -
Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes
|
N/A | |
| Completed |
NCT02837094 -
Enhanced Epidermal Antigen Specific Immunotherapy Trial -1
|
Phase 1 | |
| Recruiting |
NCT05414409 -
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
|
Phase 2 | |
| Recruiting |
NCT05670366 -
The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes
|
N/A | |
| Active, not recruiting |
NCT05418699 -
Real-life Data From Diabetic Patients on Closed-loop Pumps
|
||
| Completed |
NCT04084171 -
Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6
|
N/A | |
| Recruiting |
NCT06144554 -
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
|
||
| Recruiting |
NCT05153070 -
Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes
|
Phase 2 | |
| Recruiting |
NCT05379686 -
Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
|
N/A | |
| Completed |
NCT05281614 -
Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D
|
Early Phase 1 | |
| Withdrawn |
NCT04259775 -
Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes
|
N/A | |
| Active, not recruiting |
NCT01600924 -
Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
|
||
| Completed |
NCT02897557 -
Insulet Artificial Pancreas Early Feasibility Study
|
N/A | |
| Completed |
NCT02914886 -
Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS)
|
Phase 4 |