Evaluation of a Mobile Application to Optimize Self-decision on Metabolic Control in Persons With Type 1 Diabetes

NCT05143411 | Completed

• 1 other identifier: 2018-2019-3C1-044
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Adolescents with type 1 diabetes mellitus (T1 DM) tend to have poor metabolic control. There are no mobile applications in our language in our environment, and patients are accessible in addition to the difficulties involved in these manual calculations. One way to bridge the knowledge gaps in T1 DM self-management is by using technology to optimize metabolic control and reduce the risks of associated comorbidities, with a mobile application that helps optimize decision-making in self-management. This research aims to help people with type 1 diabetes to change the glycemic blood levels and to be able to calculate the food together with the amount of insulin with food from the region. To evaluate the acceptability and effectiveness of the application, the investigators will carry out a pilot evaluation test. The participants in this pilot test will be 20 people between 14 and 18 years old with T1DM, users of the pediatric diabetology service of the National Institute of Diabetes, Endocrinology, and Nutrition (INDEN).

Conditions

Diabetes Mellitus, Type 1

Keywords

diabetes type 1; insulin bolus calculator; macronutrients

Outcome Measures

Primary Outcomes (1)

• Change in glucose levels

  We expect to find changes in glucose levels before each main meal

  Day 01, Month 01

Secondary Outcomes (1)

• Change in glycemic variability

  Day 01, month 3

Study Arms (1)

Use of mobile application

EXPERIMENTAL

Single arm: At the first time, the researcher will collect all glycemic levels before using the mobile application. Then, all the participants will receive the mobile application to select their main meals, breakfast, lunch, and dinner. Then, the application must calculate the insulin bolus according to their initial profile and the food before being eaten.

Other: PRE-test

Interventions

PRE-test OTHER

we are going to verify glucose levels before (pre) and after (post) the use of the mobile application.

Also known as: Post-Test

Use of mobile application

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Persons with diabetes type 1

You may not qualify if:

• Persons with oral diabetes treatment.
• Glomerular filtration rate less than 60 mL/min

Sponsors & Collaborators

• Universidad Iberoamericana: lead
• Clemson University: collaborator

Study Sites (1)

Universidad Iberoamericana

Santo Domingo, Nacional, 51000, Dominican Republic

Location

Related Publications (5)

• Ewers B, Vilsboll T, Andersen HU, Bruun JM. The dietary education trial in carbohydrate counting (DIET-CARB Study): study protocol for a randomised, parallel, open-label, intervention study comparing different approaches to dietary self-management in patients with type 1 diabetes. BMJ Open. 2019 Sep 3;9(9):e029859. doi: 10.1136/bmjopen-2019-029859.

  PMID: 31481560 BACKGROUND

• Darby A, Strum MW, Holmes E, Gatwood J. A Review of Nutritional Tracking Mobile Applications for Diabetes Patient Use. Diabetes Technol Ther. 2016 Mar;18(3):200-12. doi: 10.1089/dia.2015.0299. Epub 2016 Mar 7.

  PMID: 26950679 BACKGROUND

• Goksen D, Atik Altinok Y, Ozen S, Demir G, Darcan S. Effects of carbohydrate counting method on metabolic control in children with type 1 diabetes mellitus. J Clin Res Pediatr Endocrinol. 2014;6(2):74-8. doi: 10.4274/Jcrpe.1191.

  PMID: 24932599 BACKGROUND

• Dias VM, Pandini JA, Nunes RR, Sperandei SL, Portella ES, Cobas RA, Gomes MB. Effect of the carbohydrate counting method on glycemic control in patients with type 1 diabetes. Diabetol Metab Syndr. 2010 Aug 17;2:54. doi: 10.1186/1758-5996-2-54.

  PMID: 20716374 BACKGROUND

• Son O, Efe B, Son NE, Akalin A, Kebapci N. Investigation on carbohydrate counting method in type 1 diabetic patients. Biomed Res Int. 2014;2014:176564. doi: 10.1155/2014/176564. Epub 2014 Aug 17.

  PMID: 25202704 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Evaluation Studies as Topic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Evaluating pre-test and post-test (pre and post glucose levels)

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: December 3, 2021
• Study Start: October 8, 2021
• Primary Completion: March 8, 2022
• Study Completion: March 28, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Starting six month after publication 2022
• Access Criteria: It will be able on-demand, email to principal investigator at Iberoamerican University (UNIBE): j.cepeda1@unibe.edu.do

Locations

DO (1)