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

Primary Purpose

Type 2 Diabetes Treated With Insulin

Status

Completed

Phase

Not Applicable

Locations

Colombia

Study Type

Interventional

Intervention

mHealth

Usual Care

About this trial

This is an interventional supportive care trial for Type 2 Diabetes Treated With Insulin focused on measuring Type 2 diabetes, Telemedicine, mHealth, ClouDi, Hospital

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital San Ignacio Hospital San Ignacio

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

mHealth

Control

Arm Description

Intervention group (mHealth platform users).

Usual Care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT05372471

First Posted

May 8, 2022

Last Updated

May 8, 2022

Sponsor

Hospital Universitario San Ignacio

1. Study Identification

Unique Protocol Identification Number

NCT05372471

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

October 1, 2020 (Actual)

Primary Completion Date

May 31, 2021 (Actual)

Study Completion Date

August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital Universitario San Ignacio

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Treated With Insulin

Keywords

Type 2 diabetes, Telemedicine, mHealth, ClouDi, Hospital

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized controlled clinical trial, not blinded.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

mHealth

Arm Type

Other

Arm Description

Intervention group (mHealth platform users).

Arm Title

Control

Arm Type

Other

Arm Description

Usual Care

Intervention Type

Other

Intervention Name(s)

mHealth

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Usual Care

Intervention Description

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.

Primary Outcome Measure Information:

Title

HbA1c change

Description

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Severe Hypoglycemia

Description

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.

Time Frame

3 months

Title

Hypoglycemia level 1 and 2

Description

To compare the incidence of global and nocturnal alert events (<70mg/dl) and clinically significant hypoglycemia (<54mg/dl) in patients with DM2.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ana M Gómez Medina, Dr

Organizational Affiliation

Hospital Universitario San Ignacio

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital San Ignacio Hospital San Ignacio

City

Bogota

State/Province

Cundinamarca

ZIP/Postal Code

860.015.536-1

Country

Colombia

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

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

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