Efficacy of a Digital Educational Intervention in Patients With Type 2 Diabetes Mellitus

NCT06850129 | Completed DMC

• 2 other identifiers: DIGITAL DIABETES COACH_V_1.0.0acf93301039dc0d0207316e1a95891
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this interventional study is to evaluate the change in the HbA1c value, changes in body composition and evaluation of response using validated questionnaires of satisfaction with healthcare professionals during 6 months follow-up. The primary purpose of the study is to observe whether patients with a poor control of Diabetes type 2, in the digital intervention group through social networks can improve the control of their disease with quantifiable analytical values, as well as enhance their knowledge of the disease and its treatment, achieve greater satisfaction with healthcare professional and improve adherence to treatment. The primary hyphotesis is that people with Type 2 Diabetes who participate in an educational intervention through digitalized systems and social networks achieve better metabolic control, including a reduction in HbA1c levels, improve their quality of life, expand their knowledge about disease management, and reduce healthcare resource utilization.

Conditions

Diabetes Mellitus Type 2

Keywords

tyoe 2 Diabetes Mellitus; digital; metabolic control; social networks

Outcome Measures

Primary Outcomes (3)

• weight in Kilograms

  Participants' weight will be measured in a fasting state, with an empty bladder, and wearing light clothing. The measurement will be conducted using calibrated devices to ensure accuracy.

  From enrollment to the end of treatment at 6 months

• Hba1c in percent (lab result)

  HbA1c levels will be measured through blood analysis to assess the degree of long-term glycemic control in patients

  From enrollment to the end of treatment at 6 months

• weight and height will be combined to report BMI (Kg/m^2)

  his measurement will provide an assessment of the participant's body composition

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (2)

• FPG (Fasting plasma glucose) in mg/dl

  From enrollment to the end of treatment at 6 months

• total insulin in UI (international units)

  From enrollment to the end of treatment at 6 months

Study Arms (2)

Non intervention, usual parctice

NO INTERVENTION

Usual practice

digital intervention

EXPERIMENTAL

Behavioral: diabetes eduaction This was a multicenter, randomized, prospective study that included adults with type 2 diabetes with poor metabolic control, who started treatment with GLP-1 receptor agonists, with the ability to use digital tools, especially via smartphone. Patients were randomly assigned to either a digital intervention group or a usual care group. The intervention group received education through social networks and digital tools (pedometer activation, sending healthy habits guide-lines), in a structured program of healthy lifestyle changes. All this, through the figure of a "Digital Coach" for weekly and on-demand advice and support on an individualized basis. Baseline and follow-up data were collected on demo-graphic characteristics, clinical parameters, treatment adherence, and quality of life.

Behavioral: DIGITAL INTERVENTION

Interventions

DIGITAL INTERVENTION BEHAVIORAL

All patients received specific information about DM, treatments and po-tential complications. Then, patients were randomized to the digital interven-tion group or usual care. Those patients randomized to the intervention group were educated in the use of different social networks with access to infor-mation related to healthy lifestyle habits, dietary support, optimization of physi-cal activity, insulin titration, therapeutic targets, self-care, based on validated material from scientific societies and endorsed in diabetes education. Patients also had the valuable resource of a Digital Diabetes Coach: an online expert specializing in therapeutic education. This virtual guide provided patients with the flexibility to interact in both unidirectional and bidirectional ways, using methods such as chat boxes, audio messages, videos, and more. Through this digital medium, patients could seek guidance and have their questions re-solved.

Also known as: DIDITAL DIABETES COACH

digital intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with T2DM that started treatment with GLP-1 receptor agonists (more tha 18 years)
• Poor metabolic control (HbA1c \>7%)
• Were able to use a smartphone-based home digital tool, and access to social networks and webinars focus on diabetes education.
• Stable doses of oral antidiabetics for at least the previous 90 days before the have signed the Inform consent form.

You may not qualify if:

• Patients with lack of motivation or unable to use social networks
• Unable to read or write in Spanish
• Previous history of psychiatric disorder or serious organic disease
• Using systemic corticosteroids (\>10 days in treatment)
• Being pregnant or possibility to be during the clinical trial

Sponsors & Collaborators

• HOSPITAL VITHAS SEVILLA: lead

Study Sites (2)

Hospital Vithas Sevilla

Seville, Castilleja de LA Cuesta, 41950, Spain

Location

Fundacion Vithas

Valencia, Spain

Location

Related Publications (1)

• Caballero Mateos I, Morales Portillo C, Lainez Lopez M, Vilches-Arenas A. Efficacy of a Digital Educational Intervention for Patients With Type 2 Diabetes Mellitus: Multicenter, Randomized, Prospective, 6-Month Follow-Up Study. J Med Internet Res. 2025 Apr 10;27:e60758. doi: 10.2196/60758.

  PMID: 40209213 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Angel Vilches Arenas, Phd

  Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: randomization was carried out by a person external to the study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PRINCIPAL INVESTIGATOR

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: February 27, 2025
• Study Start: October 26, 2020
• Primary Completion: October 26, 2022
• Study Completion: October 26, 2023
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)