Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT07061301

Transition to Hospital Discharge in Insulinized Patients With Type 2 Diabetes Mellitus

Led by Instituto de Investigacion Sanitaria La Fe · Updated on 2026-01-23

80

Participants Needed

1

Research Sites

99 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This clinical study explores whether adding technological tools during hospital discharge can help people with type 2 diabetes who are starting insulin therapy achieve better treatment adherence and blood glucose control once they return home. The discharge transition period includes both the final days of hospitalization and the first weeks to months after returning home. When people with type 2 diabetes are hospitalized, they sometimes need to begin insulin therapy. After discharge, managing insulin properly is essential to avoid high or low blood sugar levels. However, many patients forget or delay insulin doses, which can lead to poor control of their diabetes. This study will compare two groups of patients. All participants will be adults with type 2 diabetes, between 18 and 70 years old, who are newly starting insulin during their hospital stay. Group 1 ("technological group") will use a continuous glucose monitor (CGM) and a smart insulin pen cap called Insulclock. These tools show real-time blood glucose data and record when and how much insulin is injected. Patients and doctors can use this information to better adjust treatment. Insulclock also includes alarms to remind patients of their doses. Group 2 ("control group") will use the same devices, but they will not see the data in real time. Instead, they will manage their insulin based on standard finger-prick blood sugar checks four times a day, as typically done in standard care. Both groups will be followed for 12 weeks after hospital discharge. Medical check-ins will occur in weeks 1, 2, 4, 8, and 12. Blood tests and treatment adjustments will be performed as needed. The main goals are: To measure if the use of technology helps patients stick to their insulin schedule (fewer missed or mistimed injections). To see if it leads to better blood glucose control (e.g., more time within the recommended range, fewer episodes of low or high glucose). To evaluate patient satisfaction with this technology and check if the number of unplanned hospital readmissions decreases. The study will take place at Hospital Universitari i Politècnic La Fe in Valencia, Spain. Around 80 patients will participate. This study is important because real-world data about the use of CGM and smart insulin devices during the hospital-to-home transition are limited. It may help improve diabetes care for people starting insulin after hospitalization.

CONDITIONS

Official Title

Transition to Hospital Discharge in Insulinized Patients With Type 2 Diabetes Mellitus

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 70 years
  • Hospitalized with type 2 diabetes mellitus (newly diagnosed or previously known but not on insulin)
  • Started insulin therapy during hospitalization with planned continuation after discharge
  • Independent in basic daily activities
  • Able to manage insulin pen, glucometer, CGM sensor, and Insulclock cap
Not Eligible

You will not qualify if you...

  • Dependent in basic daily activities
  • Medical condition or limitation preventing use of CGM or Insulclock system
  • Pregnant or planning pregnancy
  • Diagnosed with type 1 diabetes mellitus
  • Currently undergoing dialysis

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital La Fe, Valencia

Valencia, Valencia, Spain, 46026

Actively Recruiting

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Research Team

J

JUAN FRANCISCO MERINO TORRES, MEDICINE

CONTACT

D

DARIO LARA GALVEZ, Medicine

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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