Diabetes Mellitus, Type 1 Clinical Trial
Official title:
The Effect of Mobile Application Euglyca in Glycemic Control of Children and Adolescents With Diabetes Mellitus Type-1
Verified date | December 2018 |
Source | Aristotle University Of Thessaloniki |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
80 children and adolescents with Diabetes Mellitus Type 1 were enrolled in the study and were randomly assigned in the intervention group (Euglyca group) or in the control group. Patients in the Euglyca group were asked to use the application in order to calculate the bolus insulin dose. Primary outcomes of the study were the Glycosylated hemoglobin, percentage of normoglycemias and the Diabetes Treatment Satisfaction Questionnaire Score. Patients were evaluated at the baseline, 3, 6 and 12 months after the beginning of the study.
Status | Completed |
Enrollment | 80 |
Est. completion date | September 1, 2018 |
Est. primary completion date | September 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Children and adolescents with Diabetes Mellitus type 1. - Treatment with multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) - Satisfactory knowledge of the concept of carbohydrates and lipids counting Exclusion Criteria: - Use of another medical application for diabetes in the previous 3 months; - Lack of capacity of reading greek. |
Country | Name | City | State |
---|---|---|---|
Greece | Endocrine Unit of 3rd Department of Pediatrics of Aristotle University of Thessaloniki, Hippokration General Hospital | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
Aristotle University Of Thessaloniki |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Level of glycosylated hemoglobin in the 2 groups | Comparison of the level of glycosylated hemoglobin between the 2 groups | At 3 months after the baseline visit | |
Primary | Level of glycosylated hemoglobin in the 2 groups | Comparison of the level of glycosylated hemoglobin between the 2 groups | At 6 months after the baseline visit | |
Primary | Level of glycosylated hemoglobin in the 2 groups | Comparison of the level of glycosylated hemoglobin between the 2 groups | At 12 months after the baseline visit | |
Primary | Change from Baseline glycosylated hemoglobin at 3 months in the 2 groups | Comparison of the differences in the level of glycosylated hemoglobin between the 2 groups | At 3 months after the baseline visit | |
Primary | Change from 3 months glycosylated hemoglobin at 6 months in the 2 groups | Comparison of the differences in the level of glycosylated hemoglobin between the 2 groups | At 6 months after the baseline visit | |
Primary | Change from 6 months glycosylated hemoglobin at 12 months in the 2 groups | Comparison of the differences in the level of glycosylated hemoglobin between the 2 groups | At 12 months after the baseline visit | |
Secondary | Percentage of Normoglycemias in the 2 groups | Comparison of the percentage of Normoglycemias between the 2 groups | At 3 months after the baseline visit | |
Secondary | Percentage of Normoglycemias in the 2 groups | Comparison of the percentage of Normoglycemias between the 2 groups | At 6 months after the baseline visit | |
Secondary | Percentage of Normoglycemias in the 2 groups | Comparison of the percentage of Normoglycemias between the 2 groups | At 12 months after the baseline visit | |
Secondary | Diabetes Treatment Satisfaction Questionnaire (DTSQ) score in the 2 groups | Comparison of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) score between the 2 groups. DTSQ consists of 8 elements. Each element can be graded in a scale from 0 to 6. Two of the elements concern the perceived hypoglycemia or hyperglycemia. By adding the grades of each of the rest 6 elements the DTSQ score is calculated. |
At 3 months after the baseline visit | |
Secondary | Diabetes Treatment Satisfaction Questionnaire (DTSQ) score in the 2 groups | Comparison of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) score between the 2 groups. DTSQ consists of 8 elements. Each element can be graded in a scale from 0 to 6. Two of the elements concern the perceived hypoglycemia or hyperglycemia. By adding the grades of each of the rest 6 elements the DTSQ score is calculated. |
At 6 months after the baseline visit | |
Secondary | Diabetes Treatment Satisfaction Questionnaire (DTSQ) score in the 2 groups | Comparison of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) score between the 2 groups. DTSQ consists of 8 elements. Each element can be graded in a scale from 0 to 6. Two of the elements concern the perceived hypoglycemia or hyperglycemia. By adding the grades of each of the rest 6 elements the DTSQ score is calculated. |
At 12 months after the baseline visit |
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