Effectiveness and Safety Study of the DexCom™ G4 Continuous Glucose Monitoring System in Children and Adolescents With Type 1 Diabetes Mellitus

Effectiveness and Safety Study of the DexCom™ G4 Continuous Glucose Monitoring System in Children and Adolescents With Type 1 Diabetes Mellitus

Sponsors

Lead sponsor: DexCom, Inc.

Source DexCom, Inc.
Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the G4 System when worn for up to 7-days by children and adolescent subjects (6 to <18 years-old) with type 1 diabetes mellitus.

Detailed Description

Device performance will be primarily evaluated in terms of the proportion of G4 System values that are within ±20% of the study meter reference value for glucose levels >80 mg/dL and ±20 mg/dL at meter glucose levels <80 mg/dL. This proportion will be compared to the proportion of such points observed in the DexCom clinical study that will be used to apply for FDA approval of the G4 System (PTL 900360) for adults.

Safety data of the G4 System will also be collected and safety will be characterized by the incidence of Adverse Device Effects, Serious Adverse Device Events, and Unanticipated Adverse Device Effects experienced by study participants.

Overall Status Completed
Start Date August 2010
Completion Date November 2010
Primary Completion Date October 2010
Study Type Observational
Enrollment 64
Condition
Eligibility

Sampling method: Probability Sample

Criteria:

Inclusion Criteria:

- 1. Age 6 to <18 years-old;

- 2. Have been diagnosed with type 1 diabetes mellitus and are on multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) insulin therapy;

- 3. Willing not to inject insulin or wear an insulin pump insertion set within 3 inches from the Sensor site during Sensor wear;

- 4. Willing to use only the blood glucose meter provided to them for self-monitoring of blood glucose (SMBG) during Sensor wear, and willing to adhere to the protocol-specified fingerstick schedule during home use;

- 5. Willing to participate in three consecutive 7-day Sensor wear periods;

- 6. Willing to take a minimum of 7 fingersticks per day during home use (2 for calibration purposes, 5 for comparative purposes);

- 7. Willing to refrain from the use of acetaminophen during the Sensor insertion period and for at least 24-hours prior to Sensor insertion;

- 8. Willing not to schedule an magnetic resonance (MRI) scan, computed tomography (CT) scan, or x-ray, for the duration of the study;

- 9. Both subject and guardian are able to speak, read, and write English.

Exclusion Criteria:

- 1. Have extensive skin changes/diseases that preclude wearing the Sensor on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites; 2. Subjects who have a known allergy to medical-grade adhesives; 3. For participants of childbearing potential: are pregnant as demonstrated by a positive pregnancy test within 72 hours of insertion (sexually active participants of childbearing potential must use birth control during this study); 4. Have a hematocrit that is less than 30%, or greater than 55%; 5. Current participation in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study); 6. Have any condition that, in the opinion of the Investigator, would interfere with their participation in the trial or pose an excessive risk to study staff (e.g., known history of hepatitis B or C).

Gender: All

Minimum age: 6 Years

Maximum age: 17 Years

Healthy volunteers: No

Location
facility
DexCom, Inc
Location Countries

United States

Verification Date

June 2011

Responsible Party

Name title: Andrew Balo/SVP, Clinical and Regulatory Affairs, and Quality Assurance

Organization: DexCom, Inc

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: CGM

Description: Blinded/Unblinded CGM wear in adjunct with SMBG meter diabetes management

Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov