Kids Diabetes Telemedicine Study (KITES) (KITES)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Other: Telemedicine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 15006
    • Department of Paediatrics, Motol University Hospital 2nd Medical Faculty in Prague, Charles University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telemedicine arm; 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; Replacement of the regullar meeting with diabetologist by remote communication only
No Intervention: Outpatient clinic meetings arm; Participants in this arm will normally come for the regular meetings with their diabetologist to the outpatient clinic.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Motol
• Investigators: Principal Investigator: Lenka Petruzelkova, MD, PhD., Motol University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Anticipated): July 30, 2022
• Study Completion (Anticipated): August 15, 2022

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Telemedicine; Type 1 diabetes children; Virtual clinic
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 01-CIP-24-02-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: We plan to share the anonymised participants' data on individual request
• IPD Sharing Time Frame: 6 months after study termination, for 2 years time
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No