NCT02159638

Brief Summary

Continuous glucose monitoring (CGM) is a tool used in the treatment of patients with type 1 diabetes. A continuous glucose monitor (CGM) is a subcutaneous tissue sensor, which provides a tissue fluid glucose measurement every 1 to 5 minutes. Since CGM measure the glucose level by a sensor in subcutaneous tissue, there is uncertainty in the estimation of blood glucose levels. The accuracy of a certain CGM system can be assessed by comparing the glucose levels estimated by CGM with measured glucose levels in plasma. In the current study, we will compare the accuracy of the 2 CGM systems available on the market for clinical use in patients with type 1 diabetes. The aim of the current study is to evaluate effectiveness, safety and treatment satisfaction with 2 different CGM systems among adult type 1 diabetic patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2014

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

December 19, 2017

Status Verified

June 1, 2014

Enrollment Period

1.2 years

First QC Date

June 5, 2014

Last Update Submit

December 18, 2017

Conditions

Diabetes Mellitus, Type 1Blood Glucose

Keywords

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Insulin-DependentEndocrine System DiseasesBlood glucoseBlood Glucose, Self-Monitoring

Outcome Measures

Primary Outcomes (1)

  • Difference between the two CGM systems compared to capillary glucose value

    Primary efficacy analysis will be investigating whether there is a statistically significant difference between the two CGM systems with respect to mean absolute relative difference (MARD) of estimated capillary glucose value over the whole study period.

    6 days

Secondary Outcomes (5)

  • the accuracy of the 2 CGM systems during each studied time interval (day 1-3 and day 4-6)

    day 1-3 and day 4-6

  • the accuracy of the 2 CGM systems for hypoglycaemia

    6 days

  • the accuracy of the 2 CGM systems for normoglycaemia

    6 days

  • the accuracy of the 2 CGM systems for hyperglycaemia

    6 days

  • Evaluation of two CGM systems from questionnaire

    day 6

Study Arms (1)

comparisson CGM accuracy

OTHER

Each patient will have both subcutaneous tissue CGM sensors (Guardian Enlite sensor and Dexcom G4 Platinum sensor) inserted at the same time. The HemoCue Analyser- venous blood and finger-stick blood in cuvette, will be used to measure the concentration of glucose

Device: Guardian Enlite sensorDevice: Dexcom G4 platinum sensor

Interventions

Guardian Enlite sensorDEVICE

Sensor insertion

comparisson CGM accuracy
Dexcom G4 platinum sensorDEVICE

Sensor insertion

comparisson CGM accuracy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetes
  • Adult patients, age 18 or older and \<75 years.
  • Written Informed Consent

You may not qualify if:

  • Pregnancy
  • Patients with severe cognitive dysfunction or other disease which makes CGM use difficult.
  • Patients requiring continuous use of paracetamol. Paracetamol must not have been used
  • the week before the study and shall not be used during the duration because it disturbs the
  • interpretation of blood glucose levels estimated by the DexCom4G. However, other pain
  • killers can be used throughout the study period.
  • Current CGM use
  • History of allergic reaction to any of the CGMS materials
  • or adhesives in contact with the skin.
  • History of allergic reaction to chlorhexidine or alcohol
  • anti-septic solution.
  • Abnormal skin at the anticipated glucose sensor
  • attachment sites (excessive hair, burn, inflammation,
  • infection, rash, and/or tattoo).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NU-hospital Organisation

Trollhättan, 46173, Sweden

Location

Uddevalla hospital

Uddevalla, 45180, Sweden

Location

Related Publications (1)

  • Matuleviciene V, Joseph JI, Andelin M, Hirsch IB, Attvall S, Pivodic A, Dahlqvist S, Klonoff D, Haraldsson B, Lind M. A clinical trial of the accuracy and treatment experience of the Dexcom G4 sensor (Dexcom G4 system) and Enlite sensor (guardian REAL-time system) tested simultaneously in ambulatory patients with type 1 diabetes. Diabetes Technol Ther. 2014 Nov;16(11):759-67. doi: 10.1089/dia.2014.0238. Epub 2014 Sep 18.

    PMID: 25233297DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes MellitusEndocrine System Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2014

First Posted

June 10, 2014

Study Start

May 1, 2013

Primary Completion

July 1, 2014

Study Completion

September 1, 2014

Last Updated

December 19, 2017

Record last verified: 2014-06

Locations

SE(2)