Intensified Insulin TherapyNCT05100576
Intensified Insulin Therapy With Telemedicine
A study testing Telemedicine system users in people with Intensified Insulin Therapy and Diabetes, run by Szeged University at 1 site in Hungary.
Trial summary
Investigation of the effect of a 3-month telemedicine-led lifestyle intervention in individuals requiring intensified insulin therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intensified Insulin Therapy, Diabetes
- What is being tested?
- Telemedicine system users
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jul 2021to 31 Oct 2021
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women or men between the ages of 18 and 75
- Patient with Diabetes who needs intensified insulin therapy HbA1c> = 8%
- IT proficiency is at least basic for cell phones (answering / making a voice call).
- Signing a informed consent
- For women with childbearing potential, by definition, all women who who are physiologically able to conceive are twofold use of contraception
- The subject communicates well with the investigator and is able to perform the test to understand and help comply with the requirements of the protocol
Who cannot join
- informed refusal any time after the sign of the informed consent
- Planned invasive cardiac intervention (catheter vasodilation or surgical coronary artery bypass grafting, keyboard surgery or replacement)
- Tumor disease
- Pregnant or lactating women
- Any medical condition that does not allow participation
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
University of Szeged
Szeged, 6720
István Kósa, MD Ph.D., +36 70 320 1192, office.prevmedicina@med.u-szeged.hu
Csaba Lengyel, Prof.Dr.
About this study
Official title: Randomized Controlled Clinical Trial of Telemedicine-guided Lifestyle Intervention in Diabetic Patients During Intensive Insulin Therapy.
Investigation of the effect of a 3-month telemedicine-led lifestyle intervention in individuals requiring intensified insulin therapy.
Read the detailed description
The primary objective of this study was to evaluate the development of HbA1c levels in patients requiring 3 months of intensified insulin therapy using standard therapy and telemedicine devices currently in use.
The telemedicine system contains a mobile phone-based nutrition diary, bluetooth-related wrist activity meter, weight scale, blood pressure monitor, blood glucose meter, and IT system for transmitting and displaying data from these devices.
- Conditions
- Intensified Insulin Therapy, Diabetes
- Being tested
- Telemedicine system users
- Keywords
- telemedicine
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine system usersDevice
Telemonitoring by medical devices connected to a software system with a router.
| Study group | Role | What they receive |
|---|---|---|
| Active group | Experimental | This group gets the telemedicine system, with the devices, and gets life-style guide by telephone consultation/ visits, during 3 months Receives: Device: Telemedicine system users |
| Comparator group | No intervention | This group gets the normal, evidence based therapy, without extra visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of HbA1c level
Investigation of the effect of a 3-month telemedicine-led lifestyle intervention on HbA1c levels in individuals requiring insulin therapy
Measured: 3 months
Secondary outcomes (3)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Safety of the device system
Measured: 3 months
change of hypoglycemic episodes
Number of hypoglycemic episodes
Measured: 3 months
Difference in the decisions between the two type of visits
Consistency of investigators' decisions based on telemedicine data and personal visit
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start1 Jul 2021
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensified Insulin TherapyStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100576
- Sponsor's protocol ID
- TMED_INZULIN_001
- Status last verified
- Oct 2021
- First submitted
- 6 Oct 2021
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trial of Telemedicine-guided Lifestyle Intervention in Diabetic Patients During Intensive Insulin Therapy.
- ClinicalTrials.gov ID
- NCT05100576
- Acronym / sponsor ID
- TMED_INZULIN_001
- Conditions
- Intensified Insulin Therapy, Diabetes
- Keywords
- telemedicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 29 Oct 2021 (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.
Investigation of the effect of a 3-month telemedicine-led lifestyle intervention in individuals requiring intensified insulin therapy.
Detailed description
The primary objective of this study was to evaluate the development of HbA1c levels in patients requiring 3 months of intensified insulin therapy using standard therapy and telemedicine devices currently in use.
The telemedicine system contains a mobile phone-based nutrition diary, bluetooth-related wrist activity meter, weight scale, blood pressure monitor, blood glucose meter, and IT system for transmitting and displaying data from these devices.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group | Experimental | Device: Telemedicine system usersThis group gets the telemedicine system, with the devices, and gets life-style guide by telephone consultation/ visits, during 3 months |
| Comparator group | No intervention | –This group gets the normal, evidence based therapy, without extra visits. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women or men between the ages of 18 and 75
- Patient with Diabetes who needs intensified insulin therapy HbA1c> = 8%
- IT proficiency is at least basic for cell phones (answering / making a voice call).
- Signing a informed consent
- For women with childbearing potential, by definition, all women who who are physiologically able to conceive are twofold use of contraception
Key exclusion criteria (5 listed)
- informed refusal any time after the sign of the informed consent
- Planned invasive cardiac intervention (catheter vasodilation or surgical coronary artery bypass grafting, keyboard surgery or replacement)
- Tumor disease
- Pregnant or lactating women
- Any medical condition that does not allow participation
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 |
|---|---|---|
| Telemedicine system usersTelemonitoring by medical devices connected to a software system with a router. | Device | Active group |
Primary outcome
Change of HbA1c level
Time frame: 3 months
Investigation of the effect of a 3-month telemedicine-led lifestyle intervention on HbA1c levels in individuals requiring insulin therapy
3 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 3 months
change of hypoglycemic episodes
Time frame: 3 months
Difference in the decisions between the two type of visits
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Individual participant dataSharing planned: No
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.
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 system users in people with Intensified Insulin Therapy and Diabetes, run by Szeged University at 1 site in Hungary.
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 5 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 29 Oct 2021. 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 Hungary. 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?
Contact István Kósa, Md Ph.D. (+36 70 320 1192, office.prevmedicina@med.u-szeged.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of HbA1c level (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2021.