Improving insulin management after hospital discharge for adults with type 2 diabetes
Transition to Hospital Discharge in Insulinized Patients With Type 2 Diabetes Mellitus and Incorporation Into a Comprehensive Diabetes Management System
We will test whether giving adults (18–70) with type 2 diabetes who start insulin in the hospital a continuous glucose monitor and a smart Insulclock pen cap helps them stick to insulin and control blood sugar after they go home.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Instituto de Investigacion Sanitaria La Fe Academic / other |
| Locations | 1 site (Valencia, Valencia) |
| Trial ID | NCT07061301 on ClinicalTrials.gov |
What this trial studies
This interventional study randomizes hospitalized adults with T2DM who are newly started on insulin to usual care or to a technology-supported discharge pathway. The technological group receives a continuous glucose monitor (CGM) and the Insulclock smart insulin pen cap during the final hospital days and continues using them after discharge while the usual-care group receives standard discharge education and follow-up. Investigators collect data on insulin adherence, glycemic measures from CGM or self-monitoring, and healthcare use during the weeks to months after discharge. The trial is conducted at Hospital La Fe in Valencia, Spain and focuses on practical, device-based supports to improve the vulnerable peri-discharge period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–70 with type 2 diabetes who begin insulin during a hospital stay, are independent in daily activities, and can use a CGM and smart pen cap.
Not a fit: Patients who cannot use CGM or the Insulclock device, those dependent in basic activities, pregnant people, patients with type 1 diabetes, or those on dialysis are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, this approach could help patients take insulin more reliably, improve blood sugar control, and reduce complications or readmissions after leaving the hospital.
How similar studies have performed: Previous research shows CGM and smart pen technologies can improve adherence and glycemic control individually, but evidence is limited for starting both tools during the hospital-to-home transition.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Valencia, Valencia
- Hospital La Fe, Valencia — Valencia, Valencia, Spain (Recruiting)
Study contacts
- Principal investigator: JUAN FRANCISCO MERINO TORRES, Medicine — IIS La Fe
- Study coordinator: Juan Francisco Merino Torres, Medicine
- Email: merino_jfr@gva.es
- Phone: +34617951330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.