Clinical Utility of Tight Objectives of Advanced Hybrid Closed-loop Systems Among Type 1 Diabetes Patients (TightT1AHCL)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-15

Study Completion Date

2026-04-15

Brief Summary

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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 and/or 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 mg/dL) 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.

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Detailed Description

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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 and/or 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 mg/dL limit. This system allows glycemic objective as low as 80 mg/dL.

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.

Conditions

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Type 1 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Type 1 diabetes patients treated with AHCL (CamAPS-Ypsopump)

Patients with type 1 diabetes on treatment with AHCL (CamAPS-Ypsopump) and a strict programmed glucose target (80-99 mg/dL).

Advanced hybrid closed-loop CamAPS FX

Intervention Type DEVICE

Treatment with a strict programmed glucose target (80-99 mg/dL).

Interventions

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Advanced hybrid closed-loop CamAPS FX

Treatment with a strict programmed glucose target (80-99 mg/dL).

Intervention Type DEVICE

Other Intervention Names

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Ypsopump CamAPS FX

Eligibility Criteria

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Inclusion Criteria

* Patients with type 1 diabetes.
* Age greater than or equal to 18 years.
* HbA1c \> 7% (previous poor glycemic control condition).
* Prior treatment with MDI or aHCL.

Exclusion Criteria

* Other types of diabetes.
* Pregnancy or pre-conception control.
* Uncontrolled psychiatric disease.
* Current or previous treatment with CamAPS-Ypsopump.
* No glucometric data available during the periods under study.
* History of severe hypoglycemia.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No