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
Location: See location...
Intervention Type: Device
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Ciudad Real General University Hospital
RECRUITING
Ciudad Real
Contact Information
Primary
Ignacio González Maroto
igmaroto@sescam.jccm.es
0034-926278000
Backup
Jesus Moreno-Fernández
jmorenof@sescam.jccm.es
0034-926278000
Time Frame
Start Date: 2024-06-15
Estimated Completion Date: 2026-04-15
Participants
Target number of participants: 40
Treatments
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).
Related Therapeutic Areas
Sponsors
Leads: Castilla-La Mancha Health Service

This content was sourced from clinicaltrials.gov

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