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

Diabetes Mellitus, Type 1 Clinical Trial

— SMARTPEN  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06310980
• Other study ID #: SMARTPEN
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: March 2024
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: April 1, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Giulio Frontino

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in range	Percentage of the time spent by 70-180 mg/dl	3 months
Secondary	time below range	percentage of time < 70 mg/dl	3 months
Secondary	time above range	percentage of time spent > 180 mg/dl	3 months
Secondary	coefficient of variation (CV)	percentage of variation of glicaemic values	3 months
Secondary	HbA1c	percentage of glicated haemoglobin	3 months
Secondary	ITSRQ	questionnaire on patient's satisfaction about the use of insulin device	end of the study
Secondary	DIDS	questionnaire on patient's satisfaction about the use of insulin device	3 months