Kids Diabetes Telemedicine Study (KITES)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Kids Diabetes Telemedicine Study (KITES)

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Other: Telemedicine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised prospective single-center trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine arm<br>Participants in this arm will be follow up by telemedicine control (via emails) instead of regular controls. They will upload the data from their devices (pump, CGM) to cloud system on their own. All instructions what to change they will recive by email only. | Other: Telemedicine<br>* Replacement of the regullar meeting with diabetologist by remote communication only<br>|
| No Intervention: Outpatient clinic meetings arm<br>Participants in this arm will normally come for the regular meetings with their diabetologist to the outpatient clinic. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metabolic control (HbA1c concentrations) at Month 9 | The noninferiority of HbA1C concentration between the groups (the difference of HbA1c between the groups will be less than 5 mmol/mol, | Month 9 visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Control of glycemia levels by CGM data evaluation. | To compare the CGM data (time in range, hypoglyceamia, hyperglycaemia, SD, ...) between the groups. | Month 3, Month 6, and Month 9 | 
| Duration of the dia visit | 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 | Month 3and Month 6 | 
| Patient´s satisfaction of regular and telemedicine (email) visits. | Patient´s satisfaction of regular and telemedicine (email) visits wil be compared by special questionnare. | Month 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 diabetes children, Telemedicine, Virtual clinic