Clinical trial NCT05484427: Kids Diabetes Telemedicine Study (KITES)
Official title: Kids Diabetes Telemedicine Study (KITES)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes children
Telemedicine
Virtual clinic
Lead sponsor: University Hospital, Motol
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised prospective single-center trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: metabolic control (HbA1c concentrations) at Month 9
timeFrame: Month 9 visit
Secondary outcomes:
measure: Control of glycemia levels by CGM data evaluation.
timeFrame: Month 3, Month 6, and Month 9
measure: Duration of the dia visit
timeFrame: Month 3and Month 6
measure: Patient´s satisfaction of regular and telemedicine (email) visits.
timeFrame: Month 9
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Department of Paediatrics, Motol University Hospital 2nd Medical Faculty in Prague, Charles University
Study officials:
affiliation: Motol University Hospital
name: Lenka Petruzelkova, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References: