Accuracy of Two CGM Systems Tested Simultaneously in Ambulatory Patients With Type 1 Diabetes

December 18, 2017 updated by: Vastra Gotaland Region
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Each study patient will have both subcutaneous tissue CGM sensors inserted. Each sensor will produce a maximum of 1,440 tissue fluid glucose measurements per 24 hours and 8,460 measurements during the 6 days in study. The plan is to study 36 to 50 ambulatory patients during the hole study period. The two CGM data sets (DexCom4G and Medtronic Enlite) will be compared to each other and the time-matched reference blood glucose measurements.

The HemoCue Analyser- venous blood and finger-stick blood in cuvette, will be used to measure the concentration of glucose.

Each ambulatory patient will sample capillary blood and measure the concentration of glucose 6 to 10 times per day for max 6 days. The concentration of finger-stick capillary blood glucose will be measured using the HemoCue meter in their daily living and additionally a HemoCue Analyser at research visits using a lancet. Each patient will be admitted to the clinical research unit (CRU) for 7 measurements of venous samples at two occasions: on day 1-3 and 4-6 of the study with an interval of at least 15 minutes. An intravenous catheter will be inserted to facilitate blood sample acquisition each of these days of study. Three capillary finger-stick blood will be sampled at these 2 occasions, 1 at the first venous measurement (one day of days 1-3) and one at the last venous sample (one day of days 4-6).

Blood sample acquisition and handling will be standardized to minimize pre-analytical error.

The sensor insertion sites will be observed to detect bleeding, inflammation and infection of the skin or subcutaneous tissue. Insertion sites will be photographed if any abnormal findings exist at the end of the study for the individual patient.

The subjects will record self monitoring of blood glucose (SMBG), meal, and activity data in a written diary.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Trollhattan, Sweden, 46173
        • NU-hospital Organisation
      • Uddevalla, Sweden, 45180
        • Uddevalla Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Pregnancy
  2. Patients with severe cognitive dysfunction or other disease which makes CGM use difficult.

  3. 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.

  4. Current CGM use

  5. History of allergic reaction to any of the CGMS materials

    or adhesives in contact with the skin.

  6. History of allergic reaction to chlorhexidine or alcohol

    anti-septic solution.

  7. Abnormal skin at the anticipated glucose sensor

attachment sites (excessive hair, burn, inflammation,

infection, rash, and/or tattoo).

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: comparisson CGM accuracy
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 sensor
Sensor insertion
Device: Dexcom G4 platinum sensor
Sensor insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between the two CGM systems compared to capillary glucose value
Time Frame: 6 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
the accuracy of the 2 CGM systems during each studied time interval (day 1-3 and day 4-6)
Time Frame: day 1-3 and day 4-6
Accuracy of all estimated capillary glucose values (registered both during days 1-3 and days 4-6) of DexCom 4G system (DexCom sensor) vs Guardian Real-Time system (Enlite sensor) system compared to the capillary reference blood glucose measured with HemoCue.
day 1-3 and day 4-6
the accuracy of the 2 CGM systems for hypoglycaemia
Time Frame: 6 days
Accuracy in estimating capillary glucose levels <4 registered both during days 1-3 and days 4-6 of DexCom 4G system (DexCom sensor) vs Guardian Real-Time system (Enlite sensor) system compared to the capillary reference blood glucose measured with HemoCue(hypo, normoglycaemia and hyperglycaemia)
6 days
the accuracy of the 2 CGM systems for normoglycaemia
Time Frame: 6 days
Accuracy in estimating capillary glucose levels of 4.0-10.0 mmol/l registered both during days 1-3 and days 4-6 of DexCom 4G system (DexCom sensor) vs Guardian Real-Time system (Enlite sensor) system compared to the capillary reference blood glucose measured with HemoCue
6 days
the accuracy of the 2 CGM systems for hyperglycaemia
Time Frame: 6 days
Accuracy in estimating capillary glucose levels >14.0 mmol/l registered both during days 1-3 and days 4-6 of DexCom 4G system (DexCom sensor) vs Guardian Real-Time system (Enlite sensor) system compared to the capillary reference blood glucose measured with HemoCue
6 days
Evaluation of two CGM systems from questionnaire
Time Frame: day 6
Evaluation of DexCom 4G system (DexCom sensor) vs Guardian Real-Time system (Enlite sensor) from questionnaire
day 6

Collaborators and Investigators

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

Sponsor

Vastra Gotaland Region

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

June 5, 2014

First Submitted That Met QC Criteria

June 5, 2014

First Posted (Estimate)

June 10, 2014

Study Record Updates

Last Update Posted (Actual)

December 19, 2017

Last Update Submitted That Met QC Criteria

December 18, 2017

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGFOUREG-387191

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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