RecruitingNot ApplicableNCT07061301

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

Transition to Hospital Discharge in Insulinized Patients With Type 2 Diabetes Mellitus and Incorporation Into a Comprehensive Diabetes Management System


Sponsor

Instituto de Investigacion Sanitaria La Fe

Enrollment

80 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a structured transition plan to help people with type 2 diabetes who are started on insulin during a hospital stay successfully continue their insulin therapy after they go home. Many patients struggle with insulin management after discharge, and this study aims to identify and address the barriers. **You may be eligible if...** - You are between 18 and 70 years old - You are hospitalized with type 2 diabetes — either newly diagnosed during this admission or previously known but never on insulin before - You were started on insulin during your hospital stay, and your doctor plans for you to continue insulin after discharge - You are able to perform daily activities independently - You are willing to attend follow-up visits after discharge **You may NOT be eligible if...** - You have type 1 diabetes or another specific type of diabetes (e.g., MODY or steroid-induced) - You were already on insulin before this hospitalization - You have significant cognitive impairment preventing you from managing your own diabetes - You are being discharged to a nursing home or long-term care facility - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEUsual 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.

DEVICETechnological 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.


Locations(1)

Hospital La Fe, Valencia

Valencia, Valencia, Spain

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NCT07061301


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