Kids Diabetes Telemedicine Study (KITES)

Type 1 Diabetes Clinical Trial

— KITES  

Official title:

Kids Diabetes Telemedicine Study (KITES)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05484427
• Other study ID #: 01-CIP-24-02-2021
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: August 15, 2022

Study information

• Verified date: August 2022
• Source: University Hospital, Motol
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: August 15, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Telemedicine
Replacement of the regullar meeting with diabetologist by remote communication only

Locations

Country	Name	City	State
Czechia	Department of Paediatrics, Motol University Hospital 2nd Medical Faculty in Prague, Charles University	Prague

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Motol

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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