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

March 12, 2024 updated by: Giulio Frontino

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: smartpen
patients treated by smartpen, glucose sensor and connected by a digital application
Device: smartpen
use of a smartpen connected with glucose sensor by an digital application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in range
Time Frame: 3 months
Percentage of the time spent by 70-180 mg/dl
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Giulio Frontino

Investigators

  • Principal Investigator: Riccardo Bonfanti, M.D., IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMARTPEN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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