Evaluation of a Mobile Application to Optimize Self-decision on Metabolic Control in Persons With Type 1 Diabetes (DM-BLUE)
Evaluation of a Mobile Application to Optimize Decision-making in Self-management and Reduction of Complications in Persons With Type 1 Diabetes
Study Overview
Detailed Description
Metabolic lack of control in patients with type 1 diabetes Mellitus (T1DM) leads to kidney failure, non-traumatic amputations, blindness, and reduced life expectancy. In addition, determining the content of macronutrients in food is not the domain of many patients, particularly adolescents, or some physicians, making insulin adjustment difficult, one of the main failures of optimal metabolic control. One way to bridge the knowledge gaps in T1D 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. And a reduction of complications in adolescents (14-18 years) with T1DM. This project aims to develop this application that contributes to decision-making and the reduction of comorbidities of adolescents with T1DM, following the policies of the Dominican state through Digital systems, together with its educational mission, technological access, and national competitiveness.
There are no mobile applications in use in the Dominican Republic for the self-management of chronic diseases. Therefore, the investigators have designed a mobile application with a postprandial insulin bolus calculator. In addition, the developers has added a list of foods from the region where users can select their foods and adjust them with the amount of insulin to metabolize them. The methodology includes a mixed approach (qualitative and quantitative) before starting the study and after three months of using the application.
To evaluate the acceptability and effectiveness of the application, we 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 INDEN. This experimental study has a systematized probabilistic sample from the center's master list. They were randomized, not controlled. Therefore, the participants are users of the pediatric diabetology service, and included prior explanation and approval of informed consent. These 20 participants will be recruited, ensuring the equitable distribution between gender and sociodemographic data of the mentioned group while maintaining the intention to treat.
Inclusion criteria:
-Patients between 14-18 years old with diabetes type 1.
Exclusion criteria
- Patients with Glomerular filtration rate less than 60 mL/min
- Inability to use electronic devices.
- Admission due to acute decompensation of T1DM in previous 3 months, presence of more than one severe monthly hypoglycemia, or any other circumstance that requires frequent visits and intensive care.
- Inability to sign the informed consent.
The investigators invited the participants to select foods and routinely use the mobile app's insulin bolus calculator for three months.
For data analysis, the researchers are going to perform the normality test for numerical variables. Then, the categorical data presentation will be with frequencies and percentages tables and the quantitative data as means and standard deviation, and use a non-Gaussian distribution, Kruskal-Wallis and Mann-Whitney tests.
The primary endpoint, HbA1c at the beginning of the study and the end of the third month of use of the application, will be analyzed with Kruskal-Wallis and Mann-Whitney tests and for pre-test and post-test comparisons of the study group, and the multifactorial analysis of variance (ANCOVA), baseline HbA1c level and at 3 months after using the application, taking into account age as covariates. The investigators are going to use for statistical analysis the Statistical Package for the Social Sciences (SPSS), and Excel of the data obtained.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Distrito Nacional
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Santo Domingo, Distrito Nacional, Dominican Republic, 51000
- Universidad Iberoamericana
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Persons with diabetes type 1
Exclusion Criteria:
- Persons with oral diabetes treatment.
- Glomerular filtration rate less than 60 mL/min
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Use of mobile application
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.
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we are going to verify glucose levels before (pre) and after (post) the use of the mobile application.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in glucose levels
Time Frame: Day 01, Month 01
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We expect to find changes in glucose levels before each main meal
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Day 01, Month 01
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in glycemic variability
Time Frame: Day 01, month 3
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we expect to find changes in variations of coefficients
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Day 01, month 3
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-2019-3C1-044
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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