Using a digital platform to manage type 2 diabetes in a clinic setting
Organisational Models Supported by Technology for the Management of Diabetic Disease and Its Complications in a Diabetic Clinic Setting. A Randomised Controlled Trial Targeting Type 2 Diabetes Individuals With Non-ideal Glycemic Values
This study is testing whether using a digital app can help people with poorly controlled type 2 diabetes manage their condition better than standard care alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento Academic / other |
| Locations | 1 site (Trento, Trentino-Alto Adige) |
| Trial ID | NCT05629221 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of the 'TreC Diabete' digital platform in managing poorly controlled type 2 diabetes among individuals in the Autonomous Province of Trento, Italy. Participants will be randomly assigned to either use the app as part of their care plan or receive standard care. The primary outcome is the change in hemoglobin A1c (HbA1c) levels after 12 months. The study aims to assess whether the app can improve diabetes management and reduce healthcare costs through better patient engagement and data sharing with healthcare providers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with poorly controlled type 2 diabetes and access to a smartphone or tablet.
Not a fit: Patients with severe comorbidities or those unable to use a smartphone or tablet may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved glycemic control and better health outcomes for patients with type 2 diabetes.
How similar studies have performed: Other studies have shown positive outcomes using digital health interventions for diabetes management, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * being diagnosed with T2DM; * aged ≥ 18 and ≤ 85 years old; * having an HbA1c level \>7% (53 mmol/mol) and \<12% (108 mmol/mol); * being able to walk without walking aids; * having provided written informed consent; * having a smartphone or a tablet and being able to download the App that will be used to insert the required data. Exclusion Criteria: * having a BMI \<18 Kg/m² and \>45 Kg/m²; * having a sBP \<100 or \>200 mmHg and/or dBP \<50 or \>120 mmHg; * being diagnosed with a stage 5 CKD\* * being diagnosed with a NYHA stage IV; * poor collaboration (ie unwilling to modify the actual plan of control and therapy, even if not ideal) for which adherence to the study is unlikely * having no possibility of using a smartphone or a tablet * having medical conditions affecting the study participation (i.e. life expectancy \< 1 year)
Where this trial is running
Trento, Trentino-Alto Adige
- Azienda Provinciale per i Servizi Sanitari — Trento, Trentino-Alto Adige, Italy (Recruiting)
Study contacts
- Principal investigator: Sandro Inchiostro — Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento
- Study coordinator: Alexia Giovanazzi
- Email: alexia.giovanazzi@apss.tn.it
- Phone: +39 0464403398
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.