Diabetes Mellitus, Type 1SMARTPENNCT06310980
Pilot Study to Verify Effect of Smartpen Coordinated With Glucose Sensor.
A study testing smartpen in people with Diabetes Mellitus, Type 1, run by Giulio Frontino.
Trial summary
The Aim of this interventional study in to assess the effect of the use of a smartpen connected by an APP to continuous glucose sensors in a cohort of diabetic adolescents in not good metabolic control. Primary endpoint: time in range Secondary endpoints: other glucometrics, Hba1c, treatment satisfaction. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- smartpen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Apr 2025
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 12 - 18 years
- A clinical diagnosis of diabetes type 1 as determined by investigator for at least 12 months.
- HbA1c >7.5% (DCA)
- Subject is on multiple daily injection therapy (3 or more insulin injections per day one of which is a long acting insulin injection), is currently using or is willing to use insulin pens and pen cartridges and are not willing to use an insulin pump or AHCL system
- Subject is currently using a CGM or is willing to use the Guardian 4 system during the study.
- Subject and parents agree to comply with the study protocol requirements
- Subject and parents provide their signature on the Informed Consent Form
Who cannot join
- Subject is unwilling or unable to use insulin pen(s).
- Subject is in plans to use or is already using an insulin pump.
- Subject is currently using a non-Medtronic standalone CGM system and unwilling to use only the Guardian 4 system during the study.
- Subject has any unresolved adverse skin condition in the area of device placement (e.g. psoriasis, rash, Staphylococcus infection).
- Subject is actively participating in or plans to enroll in an investigational study (e.g. drug or device), other than this study, wherein they have received treatment from an investigational drug or device.
- Subject has a positive urine pregnancy test at time of screening.
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- Subject is unwilling to participate in study procedures.
- Subject is directly involved in the study as research staff.
- Subject with poorly controlled thyroid or celiac disease.
- Subject with any risk of exposure to MRI equipment, diathermy devices or other devices capable of generating strong magnetic fields
About this study
Official title: Pilot Study in Order to Verify the Effect of the Use of a Smartpen Coordinated With a Continuous Glucose Sensor by a Dedicated App, in a Group of Adolescents in Not Good Control: Sensor Augmented Smartpen.
The Aim of this interventional study in to assess the effect of the use of a smartpen connected by an APP to continuous glucose sensors in a cohort of diabetic adolescents in not good metabolic control.
Primary endpoint: time in range Secondary endpoints: other glucometrics, Hba1c, treatment satisfaction.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- smartpen
- 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.
smartpenDevice
use of a smartpen connected with glucose sensor by an digital application
| Study group | Role | What they receive |
|---|---|---|
| smartpen | Experimental | patients treated by smartpen, glucose sensor and connected by a digital application Receives: Device: smartpen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range
Percentage of the time spent by 70-180 mg/dl
Measured: 3 months
Secondary outcomes (6)
time below range
percentage of time < 70 mg/dl
Measured: 3 months
time above range
percentage of time spent > 180 mg/dl
Measured: 3 months
coefficient of variation (CV)
percentage of variation of glicaemic values
Measured: 3 months
HbA1c
percentage of glicated haemoglobin
Measured: 3 months
ITSRQ
questionnaire on patient's satisfaction about the use of insulin device
Measured: end of the study
DIDS
questionnaire on patient's satisfaction about the use of insulin device
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 posted15 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Giulio Frontino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Giulio Frontino, IRCCS San Raffaele
- Investigators
- Riccardo Bonfanti, M.D., Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310980
- Sponsor's protocol ID
- SMARTPEN
- Acronym
- SMARTPEN
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study in Order to Verify the Effect of the Use of a Smartpen Coordinated With a Continuous Glucose Sensor by a Dedicated App, in a Group of Adolescents in Not Good Control: Sensor Augmented Smartpen.
- ClinicalTrials.gov ID
- NCT06310980
- Acronym / sponsor ID
- SMARTPEN / SMARTPEN
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Giulio FrontinoUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 15 Mar 2024 (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 Aim of this interventional study in to assess the effect of the use of a smartpen connected by an APP to continuous glucose sensors in a cohort of diabetic adolescents in not good metabolic control.
Primary endpoint: time in range Secondary endpoints: other glucometrics, Hba1c, treatment satisfaction.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| smartpen | Experimental | Device: smartpenpatients treated by smartpen, glucose sensor and connected by a digital application |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age between 12 - 18 years
- A clinical diagnosis of diabetes type 1 as determined by investigator for at least 12 months.
- HbA1c >7.5% (DCA)
- Subject is on multiple daily injection therapy (3 or more insulin injections per day one of which is a long acting insulin injection), is currently using or is willing to use insulin pens and pen cartridges and are not willing to use an insulin pump or AHCL system
- Subject is currently using a CGM or is willing to use the Guardian 4 system during the study.
Key exclusion criteria (10 listed)
- Subject is unwilling or unable to use insulin pen(s).
- Subject is in plans to use or is already using an insulin pump.
- Subject is currently using a non-Medtronic standalone CGM system and unwilling to use only the Guardian 4 system during the study.
- Subject has any unresolved adverse skin condition in the area of device placement (e.g. psoriasis, rash, Staphylococcus infection).
- Subject is actively participating in or plans to enroll in an investigational study (e.g. drug or device), other than this study, wherein they have received treatment from an investigational drug or device.
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 |
|---|---|---|
| smartpenuse of a smartpen connected with glucose sensor by an digital application | Device | smartpen |
Primary outcome
Time in range
Time frame: 3 months
Percentage of the time spent by 70-180 mg/dl
6 secondary outcomes
time below range
Time frame: 3 months
time above range
Time frame: 3 months
coefficient of variation (CV)
Time frame: 3 months
HbA1c
Time frame: 3 months
ITSRQ
Time frame: end of the study
DIDS
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 15 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.
Riccardo Bonfanti, M.D. principal investigator
IRCCS San Raffaele
Questions about this trial
What is this clinical trial studying?
A study testing smartpen in people with Diabetes Mellitus, Type 1, run by Giulio Frontino.
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 7 inclusion and 10 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 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Time in range (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 15 Mar 2024.