search
Back to results

Evaluation of a Flash Glucose Monitoring System in Ambulatory Patients With Type 1 Diabetes

Primary Purpose

Diabetes Mellitus, Type 1, Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Flash Glucose Monitor
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Blood Glucose, Blood Glucose Self-Monitoring

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 FGM use difficult
  3. History of allergic reaction to any of the FGMs materials or adhesives in Contact with the skin.
  4. History of allergic reaction to chlorhexidine or alcohol anti-septic solution.
  5. Continous Glucose Monitor (CGM) or FGM usage in the last month

  6. Abnormal skin at the anticipated glucose sensor attachment sites(excessive hair, burn, inflammation, infection, rash, and/or tattoo)

    -

Sites / Locations

  • NU-Hospital Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Flash Glucose Monitor

Arm Description

Each patient with Type 1 diabetes will have a subcutaneous tissue FGM sensor inserted. The sensor will produce a maximum of 1440 tissue fluid glucose measurements per 24 hours and 20160 measurements during the 14 day study. The FGM data (Abbott Freestyle Libre) will be compared to the time-matched reference blood glucose measurements. Each ambulatory patient will sample capillary blood with the HemoCue meter and measure the concentration of glucose 6 to 10 times per day for 14 days. The concentration of finger-stick capillary blood glucose will be measured using the self-monitoring blood glucose (SMBG) hemocue meter in their daily living. The subjects will record SMBG, in a written diary. Subjects will dose insulin according to their routine methods throughout the 14 day study.

Outcomes

Primary Outcome Measures

Mean Absolute Relative Difference (MARD)
Mean absolute relative difference (MARD) of all estimated capillary glucose values registered during the whole study period of the Freestyle Libre system compared to the capillary reference blood glucose measured with HemoCue.

Secondary Outcome Measures

Mean absolute Difference (MAD)
Mean absolute difference(MAD) of all estimated capillary glucose values registered during the whole study period of the Freestyle Libre System compared to the capillary reference blood glucose measured with HemoCue
Pearson Correlation Coefficient
Pearson correlation coefficient (all values registered during the whole study period)between Freestyle Libre System compared to the capillary reference blood glucose measured with HemoCue
Mean absolute relative difference (MARD)
The MARD registered during day 1-7 and day 8-14 separately of the Freestyle Libre system compared to the capillary reference blood glucose measured with HemoCue
Mean absolute difference MAD
The MAD registered during day 1-7 and day 8-14 separately of the Freestyle Libre system compared to the capillary reference blood glucose measured with HemoCue
Pearson Correlation
The Pearson Correlation (data registered during day 1-7 and day 8-14 separately) between Freestyle Libre system compared to the capillary reference blood glucose measured with HemoCue
Mean absolute relative difference (MARD)
The MARD,(for data registered inte the following specified glucose ranges: < 4mmol/l, 4-10mmol/l and >10mmol/l) durin the whole study period of the Freestyle Libre system compared to the capillary reference blood glucose measured the HemoCue
Mean absolute difference (MAD)
The MAD,(for data registered inte the following specified glucose ranges: < 4mmol/l, 4-10mmol/l and >10mmol/l) durin the whole study period of the Freestyle Libre system compared to the capillary reference blood glucose measured the HemoCue
Pearson Correlation
The Pearson Correlation (for data registered inte the following specified glucose ranges: < 4mmol/l, 4-10mmol/l and >10mmol/l) between Freestyle Libre system compared to the capillary reference blood glucose measured with HemoCue
questionnaire
The evaluation of the Freestyle Libre system from a questionnaires rated on a VAS-scale (Visual analogue scale), lowest value (0) equaling to Not true at all and highest value (10) equaling to Completely true

Full Information

First Posted
January 7, 2016
Last Updated
November 14, 2016
Sponsor
Vastra Gotaland Region
search

1. Study Identification

Unique Protocol Identification Number
NCT02677454
Brief Title
Evaluation of a Flash Glucose Monitoring System in Ambulatory Patients With Type 1 Diabetes
Official Title
Evaluation of a Flash Glucose Monitoring System in Ambulatory Patients With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the accuracy of the Flash Glucose Monitoring system (FGM), Abbot FreeStyle Libre, used today in clinical practice in Sweden in estimating plasma glucose levels. Data will be collected in ambulatory patients with type 1 diabetes to determine safety, accuracy, and reliability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Diabetes Mellitus
Keywords
Blood Glucose, Blood Glucose Self-Monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flash Glucose Monitor
Arm Type
Experimental
Arm Description
Each patient with Type 1 diabetes will have a subcutaneous tissue FGM sensor inserted. The sensor will produce a maximum of 1440 tissue fluid glucose measurements per 24 hours and 20160 measurements during the 14 day study. The FGM data (Abbott Freestyle Libre) will be compared to the time-matched reference blood glucose measurements. Each ambulatory patient will sample capillary blood with the HemoCue meter and measure the concentration of glucose 6 to 10 times per day for 14 days. The concentration of finger-stick capillary blood glucose will be measured using the self-monitoring blood glucose (SMBG) hemocue meter in their daily living. The subjects will record SMBG, in a written diary. Subjects will dose insulin according to their routine methods throughout the 14 day study.
Intervention Type
Device
Intervention Name(s)
Flash Glucose Monitor
Other Intervention Name(s)
Abbott Freestyle Libre
Primary Outcome Measure Information:
Title
Mean Absolute Relative Difference (MARD)
Description
Mean absolute relative difference (MARD) of all estimated capillary glucose values registered during the whole study period of the Freestyle Libre system compared to the capillary reference blood glucose measured with HemoCue.
Time Frame
the whole study period, day 1-14
Secondary Outcome Measure Information:
Title
Mean absolute Difference (MAD)
Description
Mean absolute difference(MAD) of all estimated capillary glucose values registered during the whole study period of the Freestyle Libre System compared to the capillary reference blood glucose measured with HemoCue
Time Frame
the whole study period, day 1-14
Title
Pearson Correlation Coefficient
Description
Pearson correlation coefficient (all values registered during the whole study period)between Freestyle Libre System compared to the capillary reference blood glucose measured with HemoCue
Time Frame
the whole study period, day 1-14
Title
Mean absolute relative difference (MARD)
Description
The MARD registered during day 1-7 and day 8-14 separately of the Freestyle Libre system compared to the capillary reference blood glucose measured with HemoCue
Time Frame
the whole study period, day 1-14
Title
Mean absolute difference MAD
Description
The MAD registered during day 1-7 and day 8-14 separately of the Freestyle Libre system compared to the capillary reference blood glucose measured with HemoCue
Time Frame
the whole study period, day 1-14
Title
Pearson Correlation
Description
The Pearson Correlation (data registered during day 1-7 and day 8-14 separately) between Freestyle Libre system compared to the capillary reference blood glucose measured with HemoCue
Time Frame
the whole study period, day 1-14
Title
Mean absolute relative difference (MARD)
Description
The MARD,(for data registered inte the following specified glucose ranges: < 4mmol/l, 4-10mmol/l and >10mmol/l) durin the whole study period of the Freestyle Libre system compared to the capillary reference blood glucose measured the HemoCue
Time Frame
the whole study period, day 1-14
Title
Mean absolute difference (MAD)
Description
The MAD,(for data registered inte the following specified glucose ranges: < 4mmol/l, 4-10mmol/l and >10mmol/l) durin the whole study period of the Freestyle Libre system compared to the capillary reference blood glucose measured the HemoCue
Time Frame
the whole study period, day 1-14
Title
Pearson Correlation
Description
The Pearson Correlation (for data registered inte the following specified glucose ranges: < 4mmol/l, 4-10mmol/l and >10mmol/l) between Freestyle Libre system compared to the capillary reference blood glucose measured with HemoCue
Time Frame
the whole study period, day 1-14
Title
questionnaire
Description
The evaluation of the Freestyle Libre system from a questionnaires rated on a VAS-scale (Visual analogue scale), lowest value (0) equaling to Not true at all and highest value (10) equaling to Completely true
Time Frame
the whole study period, day 1-14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 1 diabetes Adult patients, age 18 or older and < 75 years Written informed consent - Exclusion Criteria: Pregnancy Patients with severe cognitive dysfunction or other disease which makes FGM use difficult History of allergic reaction to any of the FGMs materials or adhesives in Contact with the skin. History of allergic reaction to chlorhexidine or alcohol anti-septic solution. Continous Glucose Monitor (CGM) or FGM usage in the last month Abnormal skin at the anticipated glucose sensor attachment sites(excessive hair, burn, inflammation, infection, rash, and/or tattoo) -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus Lind, MD, Phd
Organizational Affiliation
NU-Hospital Organization, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
NU-Hospital Group
City
Uddevalla
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of a Flash Glucose Monitoring System in Ambulatory Patients With Type 1 Diabetes

We'll reach out to this number within 24 hrs