NCT06310980UnknownNot Applicable
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.
Giulio Frontino0 sites34 target enrollmentStarted: April 1, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 34
- Primary Endpoint
- Time in range
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
- •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
Arms & Interventions
smartpen
Experimental
patients treated by smartpen, glucose sensor and connected by a digital application
Intervention: smartpen (Device)
Outcomes
Primary Outcomes
Time in range
Time Frame: 3 months
Percentage of the time spent by 70-180 mg/dl
Secondary Outcomes
- time above range(3 months)
- HbA1c(3 months)
- coefficient of variation (CV)(3 months)
- ITSRQ(end of the study)
- DIDS(3 months)
- time below range(3 months)
Investigators
Giulio Frontino
sub investigator
IRCCS San Raffaele
Similar Trials
Completed
Not Applicable
Effect of Multi-Media Tool on Enrollment in Oncology Clinical TrialsLung CancerPancreatic CancerGastric CancerNCT02020252University of Chicago120
Recruiting
Not Applicable
Study to Evaluate the Impact of the Use of Alternative and Complementary Therapies on Therapeutic Adherence in Patients Treated With taMoxifen for Early Stage Breast CancerBreast CancerNCT04740697Institut Claudius Regaud200
Terminated
Not Applicable
Examining the Effects of Neuromodulation on Glucose Metabolism in Type 2 DiabetesType 2 DiabetesNCT02130401Scion NeuroStim6
Completed
Not Applicable
AML Electronic Decision AidAcute Myeloid LeukemiaNCT03442452Duke University20
Completed
Not Applicable
Assessing Cervical DystoniaDystoniaNCT03587350The Leeds Teaching Hospitals NHS Trust24