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

Summary

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

• Type 2 Diabetes Mellitus (T2DM)
• Continuous Glucose Monitoring
• CGM
• Transition to Discharge
• Smart Insulin Pen Cap

Interventions

DEVICE

Usual Care group

Participants will use the same CGM and Insulclock® devices, but in blinded mode (no data available to the patient). Insulin therapy will be adjusted using capillary blood glucose measurements (4 times daily). Device data will be collected retrospectively but not used for treatment decisions.

DEVICE

Technological group

Participants will use a real-time continuous glucose monitoring device (e.g., FreeStyle Libre 2) and the Insulclock® smart insulin pen cap. Both devices provide real-time feedback and data on insulin administration and glucose levels. Patients will adjust their insulin therapy based on these data.

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe

  lead OTHER

Principal Investigators

• JUAN FRANCISCO MERINO TORRES, Medicine · IIS La Fe

• DARIO LARA GALVEZ, Medicine · IIS La Fe

• MATILDE RUBIO ALMANZA, Medicine · IIS La Fe

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-01

Primary Completion

2026-07-31

Completion

2026-07-31

Countries

• Spain

Study Locations