NCT05484427

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2022

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
Last Updated

August 2, 2022

Status Verified

August 1, 2022

Enrollment Period

1.3 years

First QC Date

April 27, 2021

Last Update Submit

August 1, 2022

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes childrenTelemedicineVirtual clinic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Control of glycemia levels by CGM data evaluation.

    Month 3, Month 6, and Month 9

  • Duration of the dia visit

    Month 3and Month 6

  • Patient´s satisfaction of regular and telemedicine (email) visits.

    Month 9

Study Arms (2)

Telemedicine arm

EXPERIMENTAL

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

Outpatient clinic meetings arm

NO INTERVENTION

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

Interventions

TelemedicineOTHER

Replacement of the regullar meeting with diabetologist by remote communication only

Telemedicine arm

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Prague, 15006, Czechia

Location

Related Publications (1)

  • Plachy L, Neuman V, Velichova K, Slavenko MG, Santova A, Anne Amaratunga S, Obermannova B, Kolouskova S, Pruhova S, Sumnik Z, Petruzelkova L. Telemedicine maintains good glucose control in children with type 1 diabetes but is not time saving for healthcare professionals: KITES randomized study. Diabetes Res Clin Pract. 2024 Mar;209:111602. doi: 10.1016/j.diabres.2024.111602. Epub 2024 Mar 2.

    PMID: 38437986DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Lenka Petruzelkova, MD, PhD.

    Motol University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Open Label
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised prospective single-center trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator - Lenka Petruzelkova, MD, PhD.

Study Record Dates

First Submitted

April 27, 2021

First Posted

August 2, 2022

Study Start

April 15, 2021

Primary Completion

July 30, 2022

Study Completion

August 15, 2022

Last Updated

August 2, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

We plan to share the anonymised participants' data on individual request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
6 months after study termination, for 2 years time

Locations

CZ(1)