Observational Study to Evaluate the Effectiveness and Safety of the Dexcom G4 Continuous Glucose Monitoring System in Pediatrics

NCT02363907 | Completed Results

• 1 other identifier: PTL-900982
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4 System when used as an adjuvant to blood glucose testing over a 7-day period in people 2 to 17 years-old with diabetes mellitus.

Conditions

Diabetes Mellitus

Keywords

diabetes mellitus; pediatric; continuous glucose monitoring system; CGM

Outcome Measures

Primary Outcomes (1)

• Point Accuracy of CGM ISF Readings to Blood Glucose Measured by a Reference Device

  "Point Accuracy was evaluated in terms of the percentage of CGM values that were within ±20% of glucose meter reference value for glucose levels \>80 mg/dL and ±20 mg/dL of glucose meter reference values for glucose levels \<80 mg/dL

  Measured during clinic session during 7 day sensor wear period

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents with diabetes mellitus (Type 1 or Type 2)

You may qualify if:

• Ages 2 to 17 years;
• Diagnosis of diabetes mellitus;
• Treatment of diabetes with insulin and/or oral diabetes medication Note: Insulin-using subjects only - willing to avoid insulin injections or wear an insulin pump insertion set within 3 inches from the sensor site;
• Willing to refrain from the use of medications containing acetaminophen during the sensor insertion period and for one day prior to sensor insertion;
• Able to perform up to 7 fingersticks per day during home use (approximately 2 calibration fingersticks or as often as prompted by the device and approximately 5 for diabetes management and/or detection of hyper and hypoglycemia); and
• Subject or guardian is able to speak, read, and write English.

You may not qualify if:

• Extensive skin changes/diseases that preclude wearing the required number of devices 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;
• Known allergy to medical-grade adhesives;
• For subjects of childbearing potential: are pregnant as demonstrated by a positive pregnancy test within 72 hours prior to device insertion;
• Hematocrit value outside the range of the blood glucose monitoring system used in the study;
• 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);
• Planned MRI scan, CT scan, or diathermy during the week of the study; or
• Any condition that, in the opinion of the Investigator, would interfere with their participation in the trial (e.g., marked visual impairment) or pose an excessive risk to study staff handling venous blood samples (e.g., known history of hepatitis B or C, or HIV).

Sponsors & Collaborators

• DexCom, Inc.: lead

Study Sites (1)

Rocky Mountain Diabetes and Osteoporosis Center

Idaho Falls, Idaho, 83404, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Eileen Casal, RN, MSN
• Organization: Dexcom

ecasal@dexcom.com

8588759774

Study Officials

• David Liljenquist, M.D.

  Rocky Mountain Diabetes and Osteoporosis Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 16, 2015
• Study Start: September 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: July 27, 2017
• Results First Posted: July 27, 2017

Record last verified: 2015-02

Locations

US (1)