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.

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Treated With Insulin
• Intervention / Treatment: Other: mHealth; Other: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 860.015.536-1
      • Hospital San Ignacio Hospital San Ignacio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: mHealth; Intervention group (mHealth platform users).	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: Control; Usual Care	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Hospital Universitario San Ignacio
• Investigators: Principal Investigator: Ana M Gómez Medina, Dr, Hospital Universitario San Ignacio

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: May 8, 2022
• First Submitted That Met QC Criteria: May 8, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): May 12, 2022
• Last Update Submitted That Met QC Criteria: May 8, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Telemedicine; Type 2 diabetes; mHealth; ClouDi; Hospital
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: FM-CIE-0689-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: There is a plan to make the iPad and related data available after we gain acceptance for the publishing article.
• IPD Sharing Time Frame: 12 months
• IPD Sharing Access Criteria: Principal Investigator Approval
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No