Type 1 Diabetes
Conditions
Keywords
Type 1 diabetes children, Telemedicine, Virtual clinic
Brief summary
Randomised prospective single-center clinical trial evaluating the outcomes of children with type 1 diabetes followed up by remote telemedicine check-ups without their personal present at the outpatient clinic.
Detailed description
At the first study visit (visit Month 0), after obtaining the written informed consent from the parents, 50 children with type 1 diabetes will be randomised to two groups of equal size. The first group will have regular visits with their diabetologist to our outpatient clinic every 3 months (visits Month 3 and Month 6), the second group will have a remote control by email only instead of regular visits (visits Month 3 and Month 6). The CGM data and inzulin dose will be evaluated through cloud systems (Diasend, Carelink) at every control by diabetologist. The patients would be instructed about the reccomendation during the live control or by email according the group. The final meeting (visit Month 9) will take place at our outpatient clinic for both of the study groups. The CGM data, HbA1c, and the questionaire evaluating the quality of the controls will be evaluated.
Interventions
OTHERTelemedicine
Replacement of the regullar meeting with diabetologist by remote communication only
Sponsors
University Hospital, Motol
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Intervention model description
Randomised prospective single-center trial
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of type 1 diabetes * Age 1-18 years * Type 1 diabetes duration at least 12 months * Using continuous glucose monitoring for at least previous 6 months * Willingness to use continuous glucose monitoring for the whole study * Signed informed consent by the legal representatives
Exclusion criteria
* Change of the type 1 treatment modalitry (from insulin pens to insulin pump or vice versa, start the treatment with hybrid closed loop, start of the treatment with the drug affecting the glucose metabolism) in 3 months prior to the study or planning to change the treatment modality during the study * Concomitant psychiatric diagnosis diagnosed by the psychiatrist * Hospitalisation for severe hypoglycaemia and/or diabetic ketoacidosis in 1 year prior to the study initiation * Glycated hemoglobin concentration \>90 mmol/mol in 1 year prior to the study or substantially bad co-operation of the patient/parent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| metabolic control (HbA1c concentrations) at Month 9 | Month 9 visit | The noninferiority of HbA1C concentration between the groups (the difference of HbA1c between the groups will be less than 5 mmol/mol, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Control of glycemia levels by CGM data evaluation. | Month 3, Month 6, and Month 9 | To compare the CGM data (time in range, hypoglyceamia, hyperglycaemia, SD, ...) between the groups. |
| Duration of the dia visit | Month 3and Month 6 | To compare the time duration of dia visit between the groups. The time duration of each visits will be measured by doctor and patient separately. Doctor´s and patient´s time duration of the visits will be compared |
| Patient´s satisfaction of regular and telemedicine (email) visits. | Month 9 | Patient´s satisfaction of regular and telemedicine (email) visits wil be compared by special questionnare. |
Countries
Czechia
Outcome results
None listed