Pilot Study to Verify Effect of Smartpen Coordinated With Glucose Sensor.

NCT ID: NCT06310980

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-04-01

Brief 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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

smartpen

patients treated by smartpen, glucose sensor and connected by a digital application

Group Type: EXPERIMENTAL

smartpen

Intervention Type: DEVICE

use of a smartpen connected with glucose sensor by an digital application

Interventions

smartpen

use of a smartpen connected with glucose sensor by an digital application

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age between 12 - 18 years

2. A clinical diagnosis of diabetes type 1 as determined by investigator for at least 12 months.

3. HbA1c >7.5% (DCA)

4. 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

5. Subject is currently using a CGM or is willing to use the Guardian 4 system during the study.

6. Subject and parents agree to comply with the study protocol requirements

7. Subject and parents provide their signature on the Informed Consent Form

Exclusion Criteria

1. Subject is unwilling or unable to use insulin pen(s).

2. Subject is in plans to use or is already using an insulin pump.

3. Subject is currently using a non-Medtronic standalone CGM system and unwilling to use only the Guardian 4 system during the study.

4. Subject has any unresolved adverse skin condition in the area of device placement (e.g. psoriasis, rash, Staphylococcus infection).

5. 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.

6. Subject has a positive urine pregnancy test at time of screening.

7. Subject is unwilling to participate in study procedures.

8. Subject is directly involved in the study as research staff.

9. Subject with poorly controlled thyroid or celiac disease.

10. Subject with any risk of exposure to MRI equipment, diathermy devices or other devices capable of generating strong magnetic fields

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Giulio Frontino

OTHER

Sponsor Role: lead

Responsible Party

Giulio Frontino

sub investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Riccardo Bonfanti, M.D.

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Raffaele

Other Identifiers

SMARTPEN

Identifier Type: -

Identifier Source: org_study_id