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

Type 2 Diabetes Treated With Insulin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05372471
• Other study ID #: FM-CIE-0689-19
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: May 2022
• Source: Hospital Universitario San Ignacio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: August 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Poor metabolic control with HbA1C = 8% and = 11% measured using a method certified by the National Glycohemoglobin Standardization Program (NGSP), = 3 months before the screening visit.

• Patients who use insulin therapy in the basal plus scheme, basal-bolus, or with two or more applications of insulin per day.

• Not having modified therapy in the last 3 months

• Availability of access to a computer to download data.

• Mobile access with data.

• The subject's compliance with capillary glucose self-monitoring parameters was greater than 80% during the baseline period after the Screening Visit.

• Accept the study including signing the informed consent

Exclusion Criteria:

• Acute decompensation of diabetes in the last 3 months

• History of myocardial infarction or acute coronary syndrome in the last three months before recruitment.

• Treatment with glucocorticoids in the last 3 months before the screening visit or who is scheduled to receive treatment during the study period

• Visual impairment that limits the ability to view or use the mobile application

• Cognitive impairment that, in the opinion of the principal investigator or study physician, would result in non-cooperation with study procedures.

• Active neoplastic disease or in the last year and/or life expectancy less than 6 months.

• Participating in another clinical study.

• Proliferative retinopathy, amputations attributable to diabetes, and/or severe peripheral neuropathy that could interfere with the ability to participate and follow the study.

• Pregnant or lactating, or plan to become pregnant during the study period

• Real-time or intermittent continuous glucose monitoring user.

• Significant psychiatric illness, kidney disease, severe liver disease, or other illness that affects the ability to complete the study.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Treated With Insulin

Intervention

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.
• 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.

Locations

Country	Name	City	State
Colombia	Hospital San Ignacio Hospital San Ignacio	Bogota	Cundinamarca

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario San Ignacio

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c change	Evaluate the efficacy of a therapeutic strategy that integrates the use of a digital platform for diabetes care (CLOUDI) for 3 months, compared with usual care, in terms of HbA1c reduction, in patients with DM2 under follow-up in patient care centers chronic.	3 months
Secondary	Severe Hypoglycemia	To compare the incidence of severe hypoglycemia events in the 3 months of follow-up, in patients with DM2 users of the digital platform, and patients in usual management.	3 months
Secondary	Hypoglycemia level 1 and 2	To compare the incidence of global and nocturnal alert events (<70mg/dl) and clinically significant hypoglycemia (<54mg/dl) in patients with DM2.	3 months