Diabetes Mellitus, Type 1NCT04900636
Telemedicine for Patients With an Hybrid Closed Loop System
A study testing Telemedicine Arm in people with Diabetes Mellitus, Type 1, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
The primary objective is to assess the impact on quality of life after a follow-up program using a telemedicine platform designed for patients with DM1 treated with an hybrid closed loop insulin infusion system. Open-label, randomized 1:1 controlled clinical trial during 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Telemedicine Arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2021to 27 Jan 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnostic criteria for DM1 according to ADA
- They must have access to the technology that allows monitoring (mobile phone and / or computer as well as having an internet connection)
- Acceptance of participation in the study and signing of the informed consent
Who cannot join
- Gestation
- Institutionalization, serious or terminal illness or renal replacement therapy.
- Inability to undertake the training and / or acquire the degree of knowledge to use the telemedicine platform.
- Refusal to participate in the study or to sign the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Telemedicine Platform for Patients With Type 1 Diabetes Mellitus Treated With an Hybrid Closed Loop System
The primary objective is to assess the impact on quality of life after a follow-up program using a telemedicine platform designed for patients with DM1 treated with an hybrid closed loop insulin infusion system. Open-label, randomized 1:1 controlled clinical trial during 12 months.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Telemedicine Arm
- 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.
Telemedicine ArmDevice
Patients with DM1 ≥ 18 years of age, users of closed loop hybrid systems, assigned to a follow-up program using a telemedicine platform combined with face-to-face visits according to protocol.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine Arm | Experimental | Use of a telemedicine platform combined with face-to-face visits according to protocol Receives: Device: Telemedicine Arm |
| Control Arm | No intervention | conventional follow-up according to routine clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on quality of life
Health-related quality of life in patients with type 1 diabetes (the ViDa1 questionnaire). The four-dimensional structure for ViDa1 are:
- Interference of diabetes in everyday life (the minimum value: 12 and maximum value: 60) higher scores mean a worse outcome
- Self-care (the minimum value: 11 and maximum value: 55) higher scores mean a better outcome
- Well-being (the minimum value: 6 and maximum value: 30) higher scores mean a better outcome, and
- Worry about the disease (the minimum value: 5 and maximum value: 25) higher scores mean a worse outcome.
Measured: 12 months
Secondary outcomes (1)
Metabolic control
A1c levels
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start1 May 2021
- Primary completion27 Jan 2023
- Study completion27 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lía Nattero Chávez, MD PhD, Principal investigator, Hospital Ramón y CajaDiabetes, Obesity and Human Reproduction Research Group, Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900636
- Sponsor's protocol ID
- 317/19
- Status last verified
- Jun 2022
- First submitted
- 18 May 2021
- Last updated
- 8 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nattero-Chavez L, de La Calle E, Lecumberri-Pascual E, Bayona Cebada A, Ruiz Gracia T, Quintero Tobar A, Lorenzo Monino M, Sanchez Rodriguez C, Izquierdo A, Escobar-Morreale HF, Luque-Ramirez M. Comparing quality of life in traditional face-to-face visits with a hybrid approach of telemedicine with in-person follow-ups in recent users of advanced closed-loop systems: a randomized controlled clinical trial in patients with type 1 diabetes. Ther Adv Endocrinol Metab. 2024 Oct 25;15:20420188241288789. doi: 10.1177/20420188241288789. eCollection 2024.
PubMed 39493410Nattero-Chavez L, Lecumberri Pascual E, De La Calle E, Bayona Cebada A, Ruiz T, Quintero Tobar A, Lorenzo M, Sanchez C, Izquierdo A, Luque-Ramirez M, Escobar-Morreale HF. Switching to an advanced hybrid closed-loop system in real-world practice improves hypoglycemia awareness and metabolic control in adults with type 1 diabetes, particularly in those with impaired perception of hypoglycemia symptoms. Diabetes Res Clin Pract. 2023 May;199:110627. doi: 10.1016/j.diabres.2023.110627. Epub 2023 Mar 20.
PubMed 36940793
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Telemedicine Platform for Patients With Type 1 Diabetes Mellitus Treated With an Hybrid Closed Loop System
- ClinicalTrials.gov ID
- NCT04900636
- Acronym / sponsor ID
- 317/19
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 27 Jan 2023 (actual)
- First posted
- 25 May 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.
The primary objective is to assess the impact on quality of life after a follow-up program using a telemedicine platform designed for patients with DM1 treated with an hybrid closed loop insulin infusion system. Open-label, randomized 1:1 controlled clinical trial during 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine Arm | Experimental | Device: Telemedicine ArmUse of a telemedicine platform combined with face-to-face visits according to protocol |
| Control Arm | No intervention | –conventional follow-up according to routine clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnostic criteria for DM1 according to ADA
- They must have access to the technology that allows monitoring (mobile phone and / or computer as well as having an internet connection)
- Acceptance of participation in the study and signing of the informed consent
Key exclusion criteria (4 listed)
- Gestation
- Institutionalization, serious or terminal illness or renal replacement therapy.
- Inability to undertake the training and / or acquire the degree of knowledge to use the telemedicine platform.
- Refusal to participate in the study or to sign the informed consent
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 ArmPatients with DM1 ≥ 18 years of age, users of closed loop hybrid systems, assigned to a follow-up program using a telemedicine platform combined with face-to-face visits according to protocol. | Device | Telemedicine Arm |
Primary outcome
Impact on quality of life
Time frame: 12 months
Health-related quality of life in patients with type 1 diabetes (the ViDa1 questionnaire). The four-dimensional structure for ViDa1 are: * Interference of diabetes in everyday life (the minimum value: 12 and maximum value: 60) higher scores mean a worse outcome * Self-care (the minimum value: 11 and maximum value: 55) higher scores mean a better outcome * Well-being (the minimum value: 6 and maximum value: 30) higher scores mean a better outcome, and * Worry about the disease (the minimum value: 5 and maximum value: 25) higher scores mean a worse outcome.
1 secondary outcome
Metabolic control
Time frame: 12 months
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 8 Sep 2023.
- Derived from this study: PubMed 39493410Nattero-Chavez L, de La Calle E, Lecumberri-Pascual E, Bayona Cebada A, Ruiz Gracia T, Quintero Tobar A, Lorenzo Monino M, Sanchez Rodriguez C, Izquierdo A, Escobar-Morreale HF, Luque-Ramirez M. Comparing quality of life in traditional face-to-face visits with a hybrid approach of telemedicine with in-person follow-ups in recent users of advanced closed-loop systems: a randomized controlled clinical trial in patients with type 1 diabetes. Ther Adv Endocrinol Metab. 2024 Oct 25;15:20420188241288789. doi: 10.1177/20420188241288789. eCollection 2024.
- Derived from this study: PubMed 36940793Nattero-Chavez L, Lecumberri Pascual E, De La Calle E, Bayona Cebada A, Ruiz T, Quintero Tobar A, Lorenzo M, Sanchez C, Izquierdo A, Luque-Ramirez M, Escobar-Morreale HF. Switching to an advanced hybrid closed-loop system in real-world practice improves hypoglycemia awareness and metabolic control in adults with type 1 diabetes, particularly in those with impaired perception of hypoglycemia symptoms. Diabetes Res Clin Pract. 2023 May;199:110627. doi: 10.1016/j.diabres.2023.110627. Epub 2023 Mar 20.
- Individual participant dataSharing planned: No
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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.
Lía Nattero Chávez, MD PhD principal investigator
Hospital Ramón y CajaDiabetes, Obesity and Human Reproduction Research Group, Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS)
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 Arm in people with Diabetes Mellitus, Type 1, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 3 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: finished, as of the sponsor's last update on 8 Sep 2023. 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 Spain. 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?
Impact on quality of life (time frame: 12 months). 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 NCT04900636, which also lists 2 linked publications.
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 8 Sep 2023.