Ignite Creation Date:
2024-07-17 @ 10:58 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466967
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-14
Brief Title:
Clinical Utility of Tight Objectives of Advanced Hybrid Closed-loop Systems Among Type 1 Diabetes Patients TightT1AHCL
Sponsor:
Castilla-La Mancha Health Service
Organization:
Castilla-La Mancha Health Service
Study Overview
Official Title:
Clinical Utility of a Tight Glucose Objectives Through Advanced Hybrid Closed-loop Systems in Adult Patients With Type 1 Diabetes and Poor Glycemic Control
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TightT1AHCL
Brief Summary:
Diabetes is a chronic disease with a relevant public health burden Maintaining blood glucose levels as close to normal as possible is essential to avoid the associated microvascular and macrovascular complications Therefore the key to prevent andor reduce the development of these chronic complications lies in an adequate and strict glycemic control
This study consist of a prospective analytical clinical study in patients with type 1 diabetes T1D The main objective is to analyze the effect on time in range TIR 70-180 mgdL of interstitial glucose after switching to a tighter glucose objective in advanced hybrid closed-loop AHCL treated adult T1D patients previously treated with multiple dose insulin injection MDI or other AHCL systems without tighter glucose objective function
This study consist of a prospective analytical clinical study in patients with type 1 diabetes T1D The main objective is to analyze the effect on time in range TIR 70-180 mgdL of interstitial glucose after switching to a tighter glucose objective in advanced hybrid closed-loop AHCL treated adult T1D patients previously treated with multiple dose insulin injection MDI or other AHCL systems without tighter glucose objective function
Detailed Description:
Diabetes is a chronic disease with a relevant public health burden T1D is characterized by the autoimmune destruction of insulin-producing pancreatic beta cells which requires the administration of exogenous insulin for its treatment Maintaining blood glucose levels as close to normal as possible is essential to avoid the associated microvascular and macrovascular complications that affect quality of life as well as morbidity and mortality due to the deleterious long-term effects of suboptimal control Therefore the key to prevent andor reduce the development of these complications lies in adequate and strict glycemic control
On the one hand the use of advanced hybrid closed-loop AHCL systems in patients with T1D is associated with improved glycemic control and quality of life in both controlled clinical trials and real-life studies Since 2021 AHCL systems are considered the standard of care ahead of traditional MDI On the other hand among the adjustment parameters of these systems each AHCL offers different target levels of glycemic control There is previous evidence that correlates the use of the more intense modes offered by each of the systems with substantial increases in TIR improvement in the other glycometric variables as well as the development of acute or chronic complications In this regard a new AHCL system has recently been introduced in Spain CamAPS FX It is the first AHCL system with the availability of setting lycemic control targets below the traditional 100 mgdL limit This system allows glycemic objective as low as 80 mgdL
However there is no information on the benefits and safety of using tighter control targets The main objective of this study is to analyze the effect on TIR after switching to a tighter glucose objective throught AHCL among adult T1D patients previously treated with MDI or other AHCL systems without this feature
This is monocenter prospective analytical clinical study non-randomized The target population will be adult T1D patients not meeting glycemic control goals followed in Ciudad Real General University Hospital
On the one hand the use of advanced hybrid closed-loop AHCL systems in patients with T1D is associated with improved glycemic control and quality of life in both controlled clinical trials and real-life studies Since 2021 AHCL systems are considered the standard of care ahead of traditional MDI On the other hand among the adjustment parameters of these systems each AHCL offers different target levels of glycemic control There is previous evidence that correlates the use of the more intense modes offered by each of the systems with substantial increases in TIR improvement in the other glycometric variables as well as the development of acute or chronic complications In this regard a new AHCL system has recently been introduced in Spain CamAPS FX It is the first AHCL system with the availability of setting lycemic control targets below the traditional 100 mgdL limit This system allows glycemic objective as low as 80 mgdL
However there is no information on the benefits and safety of using tighter control targets The main objective of this study is to analyze the effect on TIR after switching to a tighter glucose objective throught AHCL among adult T1D patients previously treated with MDI or other AHCL systems without this feature
This is monocenter prospective analytical clinical study non-randomized The target population will be adult T1D patients not meeting glycemic control goals followed in Ciudad Real General University Hospital
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None