Kids Diabetes Telemedicine Study (KITES)

University Hospital, Motol

Status: Active, not recruiting

Conditions: Type 1 Diabetes

Treatments: Other: Telemedicine

Study type: Interventional

Funder types: Other

Identifiers

NCT05484427

01-CIP-24-02-2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Telemedicine arm

Experimental group

Description:

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.

Treatment:

Other: Telemedicine

Outpatient clinic meetings arm

No Intervention group

Description:

Participants in this arm will normally come for the regular meetings with their diabetologist to the outpatient clinic.