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Kids Diabetes Telemedicine Study (KITES) (KITES)

Primary Purpose

Type 1 Diabetes

Status
Active
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Telemedicine
Sponsored by
University Hospital, Motol
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes children, Telemedicine, Virtual clinic

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telemedicine arm

Outpatient clinic meetings arm

Arm 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.

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

Outcomes

Primary Outcome Measures

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,

Secondary Outcome Measures

Control of glycemia levels by CGM data evaluation.
To compare the CGM data (time in range, hypoglyceamia, hyperglycaemia, SD, ...) between the groups.
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
Patient´s satisfaction of regular and telemedicine (email) visits.
Patient´s satisfaction of regular and telemedicine (email) visits wil be compared by special questionnare.

Full Information

First Posted
April 27, 2021
Last Updated
August 1, 2022
Sponsor
University Hospital, Motol
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1. Study Identification

Unique Protocol Identification Number
NCT05484427
Brief Title
Kids Diabetes Telemedicine Study (KITES)
Acronym
KITES
Official Title
Kids Diabetes Telemedicine Study (KITES)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
July 30, 2022 (Anticipated)
Study Completion Date
August 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Motol

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 diabetes children, Telemedicine, Virtual clinic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised prospective single-center trial
Masking
None (Open Label)
Masking Description
Open Label
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telemedicine arm
Arm Type
Experimental
Arm 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.
Arm Title
Outpatient clinic meetings arm
Arm Type
No Intervention
Arm Description
Participants in this arm will normally come for the regular meetings with their diabetologist to the outpatient clinic.
Intervention Type
Other
Intervention Name(s)
Telemedicine
Intervention Description
Replacement of the regullar meeting with diabetologist by remote communication only
Primary Outcome Measure Information:
Title
metabolic control (HbA1c concentrations) at Month 9
Description
The noninferiority of HbA1C concentration between the groups (the difference of HbA1c between the groups will be less than 5 mmol/mol,
Time Frame
Month 9 visit
Secondary Outcome Measure Information:
Title
Control of glycemia levels by CGM data evaluation.
Description
To compare the CGM data (time in range, hypoglyceamia, hyperglycaemia, SD, ...) between the groups.
Time Frame
Month 3, Month 6, and Month 9
Title
Duration of the dia visit
Description
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
Time Frame
Month 3and Month 6
Title
Patient´s satisfaction of regular and telemedicine (email) visits.
Description
Patient´s satisfaction of regular and telemedicine (email) visits wil be compared by special questionnare.
Time Frame
Month 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lenka Petruzelkova, MD, PhD.
Organizational Affiliation
Motol University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Paediatrics, Motol University Hospital 2nd Medical Faculty in Prague, Charles University
City
Prague
ZIP/Postal Code
15006
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Kids Diabetes Telemedicine Study (KITES)

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