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Completed

NCT Number: NCT02809365

FreeStyle Libre- Effect on QOL in Type 2 Diabetes Patients

This is a randomized controlled study in type 2 diabetic patients who are presently uncontrolled on at least 2 injections of insulin daily with an A1C >7.5 % and <10%. Patients need to be stabilized on their MDI for 1 week then randomized to either SBGM or FreeStyle Libre for 10 weeks.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

E. Wolfson Medical Center, Holon, Israel

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About this study

FreeStyle Libre Flash Glucose Monitoring System is an interstitial glucose monitoring system intended to be replacement for the capillary blood glucose measurement. The system contains several features that distinguish it from exiting sensor technology including no user calibration during 14 days of wear. The sensor is applied to the upper arm of the patient and the hand-held reader is used to scan the sensor to receive glucose result along with historic results with a 15 min frequency for up to 8 hours.

An AGP (=Ambulatory Glucose Profile) report is a way to present the glucose data collected by the time of day that has several advantages: demonstrates median glucose levels and the 25-75%, 10-90% excursions as well as the tendency for hypo or hyperglycemia throughout the day. This integration of results gives a more complete picture of the glucose control throughout the week/s while eliminating the "noise" from outliers.

The hypothesis is that the addition of FreeStyle Libre system for 10 weeks to the treatment of uncontrolled Type 2 diabetic patients currently on MDI, will produce a modification of behavior/life style and improvement in treatment satisfaction, quality of life and glycemic control and reduce the number of any/major hypoglycemia events.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetes - more than 1 year
  • Age: 30 - 80 yrs
  • Treated with MDI: ≥ 2 injections daily
  • HbA1c: 7.5% to 10%
  • Willing to measure 7 daily blood tests at least one day each week
  • Willing to sign informed consent

Exclusion criteria

  • Type 1 diabetes
  • CV event within the last 6 months
  • Steroid therapy > 7 days in last 6 months
  • Retinopathy - grade 3
  • Creatinine >2 mg%

Treatment and study plan

Freestyle Libre

Device

Addition of FreeStyle Libre system for 10 weeks to the treatment of uncontrolled Type 2 diabetic patients currently on multiple daily injections

personal glucometer

Device

Subjects in the Control Group will measure blood glucose levels by personal glucometer (SMBG = self monitoring blood glucose)

Other names: SMBG

Primary outcomes

  1. Improvement of diabetes treatment satisfaction measured by the 'Diabetes Treatment Satisfaction Questionnaire' (DTSQ)

    Time frame: 10 weeks

Secondary outcomes

  1. Improvement of quality of life.

    Time frame: 10 weeks

    This outcome will be measured by a validated diabetes - specific quality of life questionnaire (DQOL).

  2. Assessment of satisfaction from the FreeStyle Libre system

    Time frame: 10 weeks

    This outcome will be measure by a questionnaire developed by the investigators using specific items evaluating the use of the Libre System.

  3. Improvement of HbA1c

    Time frame: 10 weeks

    This outcome will be measured in capillary blood sample.

  4. Percent to reach target HbA1c as defined personally by the physician

    Time frame: 10 weeks

    This outcome will be assessed using the result of the HbA1c.

  5. Reduction in hypoglycemic events <54 mg%

    Time frame: 10 weeks

    By comparing events of glucose levels below 54 mg% in the intervention group versus the control group.

  6. Reduction in hypoglycemic events <70 mg%

    Time frame: 10 weeks

    By comparing events of glucose levels below 70 mg% in the intervention group versus the control group.

Sponsors and collaborators

Lead sponsor

Wolfson Medical Center

Other Gov

Registry information

Official study title

The Impact on Quality of Life of Novel Glucose -Sensing Technology Used by Individuals With Type 2 Diabetes on Intensive-insulin Therapy

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 22, 2016
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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