Type 1 Diabetes MellitusTELEDIABNCT02812498
Teleconsultation in Type 1 Diabetes Mellitus
A study testing Teleconsultation and Standard in people with Type 1 Diabetes Mellitus, run by Niguarda Hospital at 2 sites in Italy.
Trial summary
The purpose of this study is to compare the effects on glycemic control of Teleconsultation versus standard visit in outpatient clinic for patients affected by type 1 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 5 to 50 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Teleconsultation and Standard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesItaly
- Study dates
- Jan 2015to Sep 2018
- 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 5 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients affected by type 1 diabetes mellitus, 5-50 years old under multi injection insulin therapy or under continuous subcutaneous insulin infusion
- with a feasible web access
Who cannot join
- without a feasible web access
- that need a periodic physical examination
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
AO Ospedale Civile Legnano Legnano
Legnano, 20025
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
About this study
The purpose of this study is to compare the effects on glycemic control of Teleconsultation versus standard visit in outpatient clinic for patients affected by type 1 diabetes mellitus.
Read the detailed description
The growing incidence of diabetes and the need to contain health care costs empower the necessity to identify new models to cope with regular periodic follow up of patients affected by diabetes mellitus. Telemedicine offers an acknowledged instrument to provide clinical health care at a distance, increasing patient compliance and the achievement of therapeutical goals. This study wants to verify the feasibility and the efficacy of teleconsultation in patients with type 1 diabetes mellitus. In particular by a randomized controlled approach the effects on glycemic control of patients followed by teleconsultation or traditionally in standard visit in the outpatient clinic. The patients in the teleconsultation group will arrange their bookings on a website (http://www.telediabete-fid.it/) In this website they could also access to web educational courses (mainly nutrition, insulin management, glucose monitoring auto-control) or to nutritional and psychological counselling.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Teleconsultation, Standard
- Keywords
- teleconsultation, insulin therapy, HbA1c
- 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.
TeleconsultationOther
The patients in the consultation group arranged their bookings on a website, where they could also access to web educational courses or to nutritional and psychological counselling
StandardOther
Group of patients followed in a traditional way
| Study group | Role | What they receive |
|---|---|---|
| Teleconsultation | Experimental | Teleconsultation for patients affected by type 1 diabetes mellitus Receives: Other: Teleconsultation |
| Control | Other | Standard visit in outpatient clinic for the same type of patients Receives: Other: Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycosylated hemoglobin HbA1c
HbA1c is the main parameter representing the overall glycemic control. HbA1c can be assessed on three month bases but the value at 12 month is more representative of a sustained effect of this new approach
Measured: 12th month
Secondary outcomes (3)
HbA1c glycosylated hemoglobin
changes of HbA1c glycosylated hemoglobin values
Measured: 3rd to 6th to 9th month
Patient satisfactory assessment by a questionnaire on their perception of advantages (diabetes management, comfort and convenience) and limits (technical problems, poor interaction with physicians) of the service
A score of 1 (low) to 5 (High) will be used
Measured: 12th month
Cost analysis by patient estimation through a questionnaire of the overall cost and time saved thanks to the service
The average amount of cost and time saved will be calculated
Measured: 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startJan 2015
- Primary completionJul 2018
- Study completionSep 2018
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 Diabetes MellitusStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812498
- Sponsor's protocol ID
- 535-B-102014
- Acronym
- TELEDIAB
- Status last verified
- Mar 2019
- First submitted
- 16 Jun 2016
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Bertuzzi F, Stefani I, Rivolta B, Pintaudi B, Meneghini E, Luzi L, Mazzone A. Teleconsultation in type 1 diabetes mellitus (TELEDIABE). Acta Diabetol. 2018 Feb;55(2):185-192. doi: 10.1007/s00592-017-1084-9. Epub 2017 Dec 5.
PubMed 29209814
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teleconsultation in Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02812498
- Acronym / sponsor ID
- TELEDIAB / 535-B-102014
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- teleconsultation, insulin therapy, HbA1c
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 24 Jun 2016 (estimated)
- 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.
The purpose of this study is to compare the effects on glycemic control of Teleconsultation versus standard visit in outpatient clinic for patients affected by type 1 diabetes mellitus.
Detailed description
The growing incidence of diabetes and the need to contain health care costs empower the necessity to identify new models to cope with regular periodic follow up of patients affected by diabetes mellitus. Telemedicine offers an acknowledged instrument to provide clinical health care at a distance, increasing patient compliance and the achievement of therapeutical goals. This study wants to verify the feasibility and the efficacy of teleconsultation in patients with type 1 diabetes mellitus. In particular by a randomized controlled approach the effects on glycemic control of patients followed by teleconsultation or traditionally in standard visit in the outpatient clinic. The patients in the teleconsultation group will arrange their bookings on a website (http://www.telediabete-fid.it/) In this website they could also access to web educational courses (mainly nutrition, insulin management, glucose monitoring auto-control) or to nutritional and psychological counselling.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teleconsultation | Experimental | Other: TeleconsultationTeleconsultation for patients affected by type 1 diabetes mellitus |
| Control | Other | Other: StandardStandard visit in outpatient clinic for the same type of patients |
Who may qualify
- Ages
- 5 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- patients affected by type 1 diabetes mellitus, 5-50 years old under multi injection insulin therapy or under continuous subcutaneous insulin infusion
- with a feasible web access
Key exclusion criteria (2 listed)
- without a feasible web access
- that need a periodic physical examination
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 |
|---|---|---|
| TeleconsultationThe patients in the consultation group arranged their bookings on a website, where they could also access to web educational courses or to nutritional and psychological counselling | Other | Teleconsultation |
| StandardGroup of patients followed in a traditional way | Other | Control |
Primary outcome
glycosylated hemoglobin HbA1c
Time frame: 12th month
HbA1c is the main parameter representing the overall glycemic control. HbA1c can be assessed on three month bases but the value at 12 month is more representative of a sustained effect of this new approach
3 secondary outcomes
HbA1c glycosylated hemoglobin
Time frame: 3rd to 6th to 9th month
Patient satisfactory assessment by a questionnaire on their perception of advantages (diabetes management, comfort and convenience) and limits (technical problems, poor interaction with physicians) of the service
Time frame: 12th month
Cost analysis by patient estimation through a questionnaire of the overall cost and time saved thanks to the service
Time frame: 12th month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Background: PubMed 29209814Bertuzzi F, Stefani I, Rivolta B, Pintaudi B, Meneghini E, Luzi L, Mazzone A. Teleconsultation in type 1 diabetes mellitus (TELEDIABE). Acta Diabetol. 2018 Feb;55(2):185-192. doi: 10.1007/s00592-017-1084-9. Epub 2017 Dec 5.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teleconsultation and Standard in people with Type 1 Diabetes Mellitus, run by Niguarda Hospital at 2 sites in Italy.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
glycosylated hemoglobin HbA1c (time frame: 12th month). 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 NCT02812498, 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 15 Mar 2019.