Type 1 DiabetesKITESNCT05484427
Kids Diabetes Telemedicine Study (KITES)
A study testing Telemedicine in people with Type 1 Diabetes, run by University Hospital, Motol at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Telemedicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Apr 2021to 15 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Czechia1 site
Department of Paediatrics, Motol University Hospital 2nd Medical Faculty in Prague, Charles University
Prague, 15006
About this study
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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Telemedicine
- Keywords
- Type 1 diabetes children, Telemedicine, Virtual clinic
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
Replacement of the regullar meeting with diabetologist by remote communication only
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: Month 9 visit
Secondary outcomes (3)
Control of glycemia levels by CGM data evaluation.
To compare the CGM data (time in range, hypoglyceamia, hyperglycaemia, SD, ...) between the groups.
Measured: 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
Measured: 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.
Measured: Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start15 Apr 2021
- Primary completion30 Jul 2022 (estimated)
- Study completion15 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised prospective single-center trial
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lenka Petruzelkova, University Hospital, Motol
- Investigators
- Lenka Petruzelkova, MD, PhD., Principal investigator, Motol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484427
- Sponsor's protocol ID
- 01-CIP-24-02-2021
- Acronym
- KITES
- Status last verified
- Aug 2022
- First submitted
- 27 Apr 2021
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share the anonymised participants' data on individual request
Publications
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.
PubMed 38437986
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kids Diabetes Telemedicine Study (KITES)
- ClinicalTrials.gov ID
- NCT05484427
- Acronym / sponsor ID
- KITES / 01-CIP-24-02-2021
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes children, Telemedicine, Virtual clinic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 15 Aug 2022 (estimated)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised prospective single-center trial
| Arm | Type | Receives |
|---|---|---|
| Telemedicine arm | Experimental | Other: TelemedicineParticipants 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. |
| Outpatient clinic meetings arm | No intervention | –Participants in this arm will normally come for the regular meetings with their diabetologist to the outpatient clinic. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemedicineReplacement of the regullar meeting with diabetologist by remote communication only | Other | Telemedicine arm |
Primary outcome
metabolic control (HbA1c concentrations) at Month 9
Time frame: Month 9 visit
The noninferiority of HbA1C concentration between the groups (the difference of HbA1c between the groups will be less than 5 mmol/mol,
3 secondary outcomes
Control of glycemia levels by CGM data evaluation.
Time frame: Month 3, Month 6, and Month 9
Duration of the dia visit
Time frame: Month 3and Month 6
Patient´s satisfaction of regular and telemedicine (email) visits.
Time frame: Month 9
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Derived from this study: PubMed 38437986Plachy 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.
- Individual participant dataSharing planned: Yes. We plan to share the anonymised participants' data on individual request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lenka Petruzelkova, MD, PhD. principal investigator
Motol University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine in people with Type 1 Diabetes, run by University Hospital, Motol at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
metabolic control (HbA1c concentrations) at Month 9 (time frame: Month 9 visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05484427, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.