Type 1 Diabetes Clinical Trial
Official title:
An Open-label, Randomised, 2-period Cross-over Study to Assess the Efficacy and Safety of 36-hour Closed-loop Glucose Control in Comparison With Conventional Subcutaneous Insulin Pump Treatment in Adolescents With Type 1 Diabetes
Verified date | February 2010 |
Source | University of Cambridge |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Interventional |
High variability of blood sugar levels and high incidence of night-time hypoglycaemia (low
blood sugar) in young people with type 1 diabetes (T1D) make achieving the treatment goals
in this population extremely challenging.
Our ongoing research focuses on the development of a closed-loop glucose control in children
and adolescents with T1D. The three components of the closed-loop system are a continuous
glucose monitor, an insulin pump, and a computer-based algorithm. The studies performed thus
far evaluated the efficacy and safety of overnight closed-loop glucose control. The results
showed that overnight closed-loop improved control of blood glucose and prevented nocturnal
hypoglycaemia, as compared to the conventional insulin pump therapy. The next objective is
to evaluate the efficacy and safety of closed-loop insulin delivery over a prolonged time
period, including the daytime, when normal living activities occur. This will pave the way
for a more comprehensive use of closed loop systems to control glucose levels in T1D.
The present study adopts an open-label, randomised, 2-period cross-over design whereby the
safety and efficacy of closed-loop insulin therapy will be compared with the conventional
insulin pump therapy in 12 adolescents with T1D. Participants aged 12 to 18 years will be
randomised for two 36 hour studies in a clinical research facility, during which glucose
levels will be controlled by either the computer-based closed-loop algorithm (intervention
arm) or by conventional insulin pump therapy (control arm). During both studies participants
will perform normal daily activities, i.e. playing, reading, snacking and physical activity.
On both occasions, the Actiheart, a combined heart rate and movement sensor will be used to
accurately quantify each subject's individual physical activity energy expenditure during
the 36 hour study period and for 36 hours of free living during weekday.
Status | Completed |
Enrollment | 12 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years to 18 Years |
Eligibility |
Inclusion Criteria: - The subject is between 12 and 18 years of age (inclusive) - The subject has had type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative - The subject will have been on insulin pump for at least 3 months, with good knowledge of insulin self-adjustment - HbA1c = 12% based on analysis from central laboratory Exclusion Criteria: - Non-type 1 diabetes mellitus including those secondary to chronic disease - Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results - Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers and MAO inhibitors - Known or suspected allergy against insulin - Subjects with clinical significant nephropathy, neuropathy or proliferative retinopathy as judged by the clinician - Total daily insulin dose >= 2 IU/kg - Postmenarchal girls who are pregnant or intending to become pregnant or are breastfeeding - Any coexisting cardiac and respiratory condition (including asthma) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Wellcome Trust Clinical Research Facility, Addenbrooke's Hospital | Cambridge |
Lead Sponsor | Collaborator |
---|---|
University of Cambridge | Cambridge University Hospitals NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome measure is time spent with plasma glucose concentration in the target range (3.9-10.0 mmol/L) between 24:00 on Day 1 to 08:00 on Day 3. | 32 hours | No | |
Secondary | Secondary outcomes will include: (i) Total and basal insulin delivery between 24:00 on Day 1 and 08:00 on Day 3 (36 hours) (ii) CGM glucose levels between 24:00 on Day 1 and 08:00 on Day 3 (36 hours) | 36 hours | No |
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 |
NCT02914886 -
Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS)
|
Phase 4 | |
Completed |
NCT02897557 -
Insulet Artificial Pancreas Early Feasibility Study
|
N/A |