NCT05372471

Efficacy of the Digital Platform for Diabetes Care Compared to Usual Care in Patients Diagnosed With Type 2 Diabetes.

Efficacy of Using a Digital Platform for Diabetes Care Compared to Usual Care in Patients Diagnosed With Type 2 Diabetes Mellitus Type 2.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Hospital Universitario San Ignacio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Introduction: In patients diagnosed with DM2, it is essential to achieve good metabolic control. One of the tools to optimize said control is self-monitoring with capillary glucometry or SMBG (Self Monitoring of Blood Glucose), which is indicated in all patients treated with insulin and is part of the "treat to target" strategies associated with education. Despite this, many patients do not perform self-titration of insulin due to the number of capillary glucose measurements (CG) necessary, or they do not record them adequately, which leads to therapeutic inertia. Digital platforms integrated with the use of smart mobile devices facilitate this process, and in experimental settings, they have shown a significant decrease in glycosylated hemoglobin (HbA1c) and an increase in adherence to therapy. However, at the moment there are no data about the efficacy of this system in the real population. Objective: To determine the effectiveness of the use of a digital platform for diabetes care, in terms of HbA1c reduction, compared with the usual treatment, in patients with DM2 under follow-up in a chronic patient care center. Methodology: A controlled clinical study will be carried out. Patients with a diagnosis of DM2, under follow-up in specialized centers, with poor glycemic control defined by HbA1c outside the goals and who have been discharged from a high complexity hospital will be included. Demographic, clinical, and insulin requirement variables will be recorded according to the total daily dose of insulin (DDT) in units. They will be randomly distributed into two groups; the intervention group will use SMBG integrated with a digital platform for diabetes care and the control group will use SMBG associated with usual care for 3 months. A comparison will be made between HbA1c levels, the number of episodes of severe hypoglycemia, nocturnal hypoglycemia, at baseline and 3 months.

Conditions

• Type 2 Diabetes Treated With Insulin

Interventions

Type	Name	Description
OTHER	mHealth	ClouDi is a telemedicine platform that was developed for the remote monitoring of patients with diabetes in Colombia. It incorporated the recommendations that were published in a usability pilot study that was conducted previously with an open-source cloud platform. The platform consists of a web version, a version for mobile devices and a desktop application, which is installed on the patient's personal computer, thereby allowing glucose measurements taken through the Optium Neo glucometer (Abbott Diabetes Care, Alameda, CA, USA) to be uploaded automatically to the cloud. In this trial, the glucose measurements that were uploaded to the ClouDi website, were reviewed weekly by the members of the research group who were responsible for adjusting the therapy to the insulin titration scheme prescribed for the patient. The patients were informed about these adjustments by text messages sent from the web version of ClouDi to the patient's mobile phone via pop-up notifications.
OTHER	Usual Care	They will have a regular visit after 3 months where the capillary glucose data will be evaluated in person by the clinical team, the insulin dose will be titrated according to the type of insulin and the presence of hypoglycemia.

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-05-31
• Completion: 2021-08-31
• First posted: 2022-05-12
• Last updated: 2022-05-12

Locations

1 site across 1 country: Colombia