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

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Device: smartpen

• Registration Number: NCT06310980
• Lead Sponsor: Giulio Frontino

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-12
• Last Update Submitted: 2024-03-12
• Study First Posted: 2024-03-15
• Last Update Posted: 2024-03-15
• Study Start: 2024-04-01
• Primary Completion: 2024-07-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Time in range	3 months	Percentage of the time spent by 70-180 mg/dl

Secondary Outcome Measures

Name	Time	Method
time above range	3 months	percentage of time spent \> 180 mg/dl
HbA1c	3 months	percentage of glicated haemoglobin
coefficient of variation (CV)	3 months	percentage of variation of glicaemic values
ITSRQ	end of the study	questionnaire on patient's satisfaction about the use of insulin device
DIDS	3 months	questionnaire on patient's satisfaction about the use of insulin device
time below range	3 months	percentage of time \< 70 mg/dl