NCT02809365

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Sep 2016

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

First Submitted

Initial submission to the registry

June 8, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

11 months

First QC Date

June 8, 2016

Last Update Submit

November 15, 2017

Conditions

Type 2 Diabetes

Keywords

insulin treated

Outcome Measures

Primary Outcomes (1)

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

    10 weeks

Secondary Outcomes (6)

  • Improvement of quality of life.

    10 weeks

  • Assessment of satisfaction from the FreeStyle Libre system

    10 weeks

  • Improvement of HbA1c

    10 weeks

  • Percent to reach target HbA1c as defined personally by the physician

    10 weeks

  • Reduction in hypoglycemic events <54 mg%

    10 weeks

  • +1 more secondary outcomes

Study Arms (2)

Libre

OTHER

FreeStyle Libre users: 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.

Device: FreeStyle Libre

SMBG

OTHER

Self monitoring blood glucose: patients in this arm will measure blood glucose with personal glucometer

Device: personal glucometer

Interventions

FreeStyle LibreDEVICE

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

Libre
personal glucometerDEVICE

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

Also known as: SMBG
SMBG

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

E. Wolfson Medical Center

Holon, 58100, Israel

Location

Wolfson Medical Center, Bariatric Surgery Clinic

Holon, 58100, Israel

Location

Related Publications (1)

  • Yaron M, Roitman E, Aharon-Hananel G, Landau Z, Ganz T, Yanuv I, Rozenberg A, Karp M, Ish-Shalom M, Singer J, Wainstein J, Raz I. Effect of Flash Glucose Monitoring Technology on Glycemic Control and Treatment Satisfaction in Patients With Type 2 Diabetes. Diabetes Care. 2019 Jul;42(7):1178-1184. doi: 10.2337/dc18-0166. Epub 2019 Apr 29.

    PMID: 31036546DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Pediatric Endocrinology Unit

Study Record Dates

First Submitted

June 8, 2016

First Posted

June 22, 2016

Study Start

September 1, 2016

Primary Completion

July 31, 2017

Study Completion

October 31, 2017

Last Updated

November 17, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

IL(2)