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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine arm | Experimental | 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. |
|
| Outpatient clinic meetings arm | No Intervention | Participants in this arm will normally come for the regular meetings with their diabetologist to the outpatient clinic. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine | Other | Replacement of the regullar meeting with diabetologist by remote communication only |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lenka Petruzelkova, MD, PhD. | Motol University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Paediatrics, Motol University Hospital 2nd Medical Faculty in Prague, Charles University | Prague | 15006 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38437986 | Derived | Plachy L, Neuman V, Velichova K, Slavenko MG, Santova A, Anne Amaratunga S, Obermannova B, Kolouskova S, Pruhova S, Sumnik Z, Petruzelkova L. Telemedicine maintains good glucose control in children with type 1 diabetes but is not time saving for healthcare professionals: KITES randomized study. Diabetes Res Clin Pract. 2024 Mar;209:111602. doi: 10.1016/j.diabres.2024.111602. Epub 2024 Mar 2. |
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We plan to share the anonymised participants' data on individual request
6 months after study termination, for 2 years time
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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Randomised prospective single-center trial
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Open Label
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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 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |