Type1diabetesEBIACE-1NCT05708040
Clinical Trial to Evaluate the Efficacy of the Smart Insulin Pen Compared to a Closed Loop System in Patients With Type 1 Diabetes (EBIACE-1)
A study testing InPen Medtronic and Minimed 780G system in people with Type1diabetes, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
Analysis of glycemic control, frequency of hypoglycemia, glycemic variability, patient satisfaction and patient-perceived quality of life in patients with type 1 diabetes mellitus and continuous real-time glucose monitoring, the use of a smart pen compared to a closed loop system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type1diabetes
- What is being tested?
- InPen Medtronic and Minimed 780G system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 19 Aug 2022to 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
- Candidates for both systems (closed loop or smart insulin pen) for their usual healthcare team.
- 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 both systems
- 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: Open-label, Randomized, Controlled Clinical Trial to Evaluate the Efficacy of the Smart Insulin Pen Associated With a Continuous Glucose Monitoring System Compared to a Closed Loop System in Patients With Type 1 Diabetes (EBIACE-1)
Analysis of glycemic control, frequency of hypoglycemia, glycemic variability, patient satisfaction and patient-perceived quality of life in patients with type 1 diabetes mellitus and continuous real-time glucose monitoring, the use of a smart pen compared to a closed loop system.
- Conditions
- Type1diabetes
- Being tested
- InPen Medtronic, Minimed 780G system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InPen MedtronicDevice
Patients with DM1 ≥ 18 years of age who initiate Inpen system.
Minimed 780G systemDevice
Patients with DM1 ≥ 18 years of age who initiate Minimed 780G system.
| Study group | Role | What they receive |
|---|---|---|
| Closed loop system | Active comparator | Minimed 780G (Medtronic) Receives: Device: InPen Medtronic |
| SmartPen | Experimental | InPen (Medtronic) Receives: Device: Minimed 780G system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Range
To assess the difference on the glycemic control expressed as time in range (% of time between 70-180 mg/dl of interstitial glucose).
Measured: 12 months
Secondary outcomes (4)
A1c levels
To assess the differences in serum A1c levels (%)
Measured: 12 months
Time below range
To assess the difference on the glycemic control expressed as time in below range (% of time < 70 mg/dl of interstitial glucose).
Measured: 12 months
Time above range
To assess the difference on the glycemic control expressed as time in above range (% of time >180 mg/dl of interstitial glucose).
Measured: 12 months
Health-Related Quality of Life in Patients with Type 1 Diabetes
Assess health-related quality of life in patients with type 1 diabetes (by ViDa1 questionnaire).ViDa1 questionnaire has four-dimensional structure: Interference of diabetes in everyday life, Self-care, Well-being, and Worry about the disease.
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 posted1 Feb 2023
- Study start19 Aug 2022
- 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.
- Other trials for Type1diabetesStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 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
- NCT05708040
- Sponsor's protocol ID
- 189/22
- Acronym
- EBIACE-1
- Status last verified
- Mar 2024
- First submitted
- 12 Jan 2023
- Last updated
- 26 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Randomized, Controlled Clinical Trial to Evaluate the Efficacy of the Smart Insulin Pen Associated With a Continuous Glucose Monitoring System Compared to a Closed Loop System in Patients With Type 1 Diabetes (EBIACE-1)
- ClinicalTrials.gov ID
- NCT05708040
- Acronym / sponsor ID
- EBIACE-1 / 189/22
- Conditions
- Type1diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 19 Aug 2022 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 27 Jan 2023 (actual)
- First posted
- 1 Feb 2023 (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.
Analysis of glycemic control, frequency of hypoglycemia, glycemic variability, patient satisfaction and patient-perceived quality of life in patients with type 1 diabetes mellitus and continuous real-time glucose monitoring, the use of a smart pen compared to a closed loop system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed loop system | Active comparator | Device: InPen MedtronicMinimed 780G (Medtronic) |
| SmartPen | Experimental | Device: Minimed 780G systemInPen (Medtronic) |
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
- Candidates for both systems (closed loop or smart insulin pen) for their usual healthcare team.
- 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 both systems
- 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 |
|---|---|---|
| InPen MedtronicPatients with DM1 ≥ 18 years of age who initiate Inpen system. | Device | Closed loop system |
| Minimed 780G systemPatients with DM1 ≥ 18 years of age who initiate Minimed 780G system. | Device | SmartPen |
Primary outcome
Time in Range
Time frame: 12 months
To assess the difference on the glycemic control expressed as time in range (% of time between 70-180 mg/dl of interstitial glucose).
4 secondary outcomes
A1c levels
Time frame: 12 months
Time below range
Time frame: 12 months
Time above range
Time frame: 12 months
Health-Related Quality of Life in Patients with Type 1 Diabetes
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 26 Mar 2024.
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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 InPen Medtronic and Minimed 780G system in people with Type1diabetes, 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 26 Mar 2024. 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?
Time in Range (time frame: 12 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 26 Mar 2024.