TRANSITION TO HOSPITAL DISCHARGE IN INSULINIZED PATIENTS WITH TYPE 2 DIABETES MELLITUS
Launched by INSTITUTO DE INVESTIGACION SANITARIA LA FE · Jul 2, 2025
Trial Information
Current as of July 14, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at whether using special technology can help people with type 2 diabetes who start insulin treatment while in the hospital manage their condition better once they go home. When patients leave the hospital, it can be hard to remember to take insulin correctly, which is important to keep blood sugar levels steady and avoid problems. This study compares two groups: one group will use a continuous glucose monitor (a small device that tracks blood sugar all day) and a smart insulin pen cap that records insulin doses and reminds patients when to take them. The other group will use these devices too, but won’t see the real-time data and will rely on the usual finger-prick blood sugar tests done four times daily.
The study is for adults aged 18 to 70 who have type 2 diabetes and are starting insulin treatment during a hospital stay. Participants will be followed for 12 weeks after leaving the hospital, with check-ins at several points to review their progress and adjust treatment if needed. The main goals are to see if the technology helps people take their insulin on time, improves blood sugar control, and reduces unexpected hospital visits. About 80 patients will take part at a hospital in Valencia, Spain. This research is important because it could show new ways to support patients during the tricky time when they move from hospital care back to managing diabetes on their own.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adults aged 18 to 70 years.
- • Hospitalized patients with a diagnosis of type 2 diabetes mellitus (T2DM), either newly diagnosed during admission or previously known but not previously treated with insulin.
- • Initiation of insulin therapy (basal, basal-plus, or basal-bolus regimen) during hospitalization, with planned continuation post-discharge.
- • Independent in basic activities of daily living.
- • Adequate cognitive and functional capacity to manage the required devices: insulin pen, glucometer, continuous glucose monitoring (CGM) sensor, and Insulclock® cap.
- Exclusion Criteria:
- • Dependence in basic activities of daily living.
- • Any medical condition or functional limitation precluding the use of the CGM or the Insulclock® system.
- • Pregnancy or intention to become pregnant.
- • Diagnosis of type 1 diabetes mellitus.
- • Patients undergoing dialysis.
About Instituto De Investigacion Sanitaria La Fe
Instituto de Investigación Sanitaria La Fe (IIS La Fe) is a prestigious health research institute located in Valencia, Spain, dedicated to advancing biomedical knowledge and improving patient care through innovative clinical research. Affiliated with La Fe University and Polytechnic Hospital, IIS La Fe specializes in a wide range of medical fields, including oncology, cardiology, and infectious diseases. The institute fosters collaboration among researchers, clinicians, and industry partners, aiming to translate scientific discoveries into practical applications that enhance health outcomes. With a commitment to excellence and ethical standards, IIS La Fe plays a pivotal role in driving forward the landscape of health research in Spain and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Valencia, , Spain
Patients applied
Trial Officials
JUAN FRANCISCO MERINO TORRES, Medicine
Principal Investigator
IIS La Fe
DARIO LARA GALVEZ, Medicine
Study Chair
IIS La Fe
MATILDE RUBIO ALMANZA, Medicine
Study Chair
IIS La Fe
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported