NCT02232698

Brief Summary

The purpose of this study is to evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on hypoglycaemia compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised controlled study design in adults with Type 1 diabetes using insulin.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
328

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
5 countries

23 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

September 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 5, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 10, 2017

Completed
Last Updated

April 10, 2017

Status Verified

February 1, 2017

Enrollment Period

1.1 years

First QC Date

September 3, 2014

Results QC Date

January 6, 2017

Last Update Submit

February 27, 2017

Conditions

Type 1 Diabetes Mellitus

Keywords

Sensing TechnologyType 1 Diabetes,

Outcome Measures

Primary Outcomes (1)

  • Time Spent <70 mg/dL

    Difference in time \<70 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).

    Baseline and Days 194 to 208

Secondary Outcomes (8)

  • HbA1c at 6 Months

    Baseline and Day 208

  • Time Spent <55 mg/dL and <40 mg/dL

    Baseline and Days 194 to 208

  • Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL

    Baseline and Days 194-208

  • Time Spent >180 mg/dL and >240 mg/dL

    Baseline and Days 194 to 208

  • Time in Range

    Baseline and Days 194 to 208

  • +3 more secondary outcomes

Study Arms (2)

Sensor Based Glucose Monitoring System

EXPERIMENTAL

Standard sensing system use for 6 months.

Device: Sensor Based Glucose Monitoring System

Standard Blood Glucose Monitoring

ACTIVE COMPARATOR

Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.

Device: Standard Blood Glucose Monitoring

Interventions

Sensor Based Glucose Monitoring SystemDEVICE

Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Sensor Based Glucose Monitoring System
Standard Blood Glucose MonitoringDEVICE

Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time). All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Standard Blood Glucose Monitoring

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with Type 1 diabetes for ≥ 5 years
  • On their current insulin regimen for ≥ 3 months prior to study entry
  • Screening HbA1c result ≤ 7.5% (58 mmol/mol)
  • Reports self testing of blood glucose levels on a regular basis equivalent to a minimum of 3 times daily for at least 2 months prior to study entry
  • In the investigator's opinion the subject is considered technically capable of using the Abbott Sensor Based Glucose Monitoring System
  • Aged 18 years or over.

You may not qualify if:

  • Subject has been diagnosed with hypoglycaemic unawareness (i.e. subject has a diagnosis of impaired awareness of hypoglycaemia recorded in their medical notes OR in the investigator's opinion the subject currently experiences less than minimal warning symptoms for impending hypoglycaemia)
  • Subject is currently prescribed animal insulin
  • Subject is currently prescribed oral steroid therapy or is likely to require oral steroid therapy for any acute or chronic condition during the study
  • Has known allergy to medical grade adhesives
  • Currently participating in another device or drug study that could affect glucose measurements or glucose management
  • Currently using a Continuous Glucose Monitoring (CGM) device or has used one within the previous 4 months
  • Currently using Sensor augmented pump therapy
  • Is planning to use a CGM device at any time during the study
  • A female subject who is pregnant or planning to become pregnant within the study duration
  • A breast feeding mother
  • Currently receiving dialysis treatment or planning to receive dialysis during the study
  • Has a pacemaker
  • Has experienced an acute myocardial infarction within previous 6 months
  • Has a concomitant disease or condition that may compromise subject safety including; unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any other uncontrolled medical condition
  • Has experienced an episode of confirmed or suspected diabetic ketoacidosis (DKA) in the previous 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

VIVIT-Institut am Akad. Lehrkrankenhaus Feldkirch, Innere Medizin und Kardiologie

Feldkirch, 6807, Austria

Location

Medizinische Universität Graz Abteilung für Innere Medizin, Klin. Abteilung für Endokrinologie und Stoffwechsel

Graz, 8036, Austria

Location

Medizinische Universität Innsbruck

Innsbruck, 6020, Austria

Location

Diakonissen-Krankenhaus Salzburg

Salzburg, 5020, Austria

Location

Klinik fuer Innere Medizin III Medizinische Universitaet Wien

Vienna, 1090, Austria

Location

Wilhelminenspital Medzin 5

Vienna, 1160, Austria

Location

Diabetes Klinik Bad Mergentheim

Bad Mergentheim, 97980, Germany

Location

Zentrum für Diabetologie Hamburg Bergedorf

Hamburg, 21029, Germany

Location

Diabetes-Zentrum Hannover-Nord

Hanover, 30165, Germany

Location

Diabetes Center Quakenbruck

Quakenbrück, 49610, Germany

Location

Versdias GmbH

Sūlzbach-Rosenberg, 92237, Germany

Location

Vrije Universiteit Medisch Centrum

Amsterdam, 1007 MB, Netherlands

Location

Onze Lieve Vrouwe gasthuis ( OLVG)

Amsterdam, 1090 HM, Netherlands

Location

Amphia Ziekenhuis

Breda, 4800 RK, Netherlands

Location

Bethesda Diabetes Research Center

Hoogeveen, 7909 AA, Netherlands

Location

Medisch Centrum Haaglanden

The Hague, 2512 VA, Netherlands

Location

St. Antonius Ziekenhuis

Utrecht, 3543 AZ, Netherlands

Location

Hospital Germans Trias i Pujol

Badalona, 8916, Spain

Location

Clinica Diabetologica

Gijón, 33206, Spain

Location

Servicio de Endocrinología Hospital Unversitario Cruces

Vizcaya, 48903, Spain

Location

Falu Lasarett

Falun, SE-791 29, Sweden

Location

Karolinska Universitetssjukhuset Solna

Solna, SE-171 76, Sweden

Location

Karolinska Universitetssjukhuset Huddinge

Stockholm, SE-141 86, Sweden

Location

Related Publications (3)

  • Oskarsson P, Antuna R, Geelhoed-Duijvestijn P, Krӧger J, Weitgasser R, Bolinder J. Impact of flash glucose monitoring on hypoglycaemia in adults with type 1 diabetes managed with multiple daily injection therapy: a pre-specified subgroup analysis of the IMPACT randomised controlled trial. Diabetologia. 2018 Mar;61(3):539-550. doi: 10.1007/s00125-017-4527-5. Epub 2017 Dec 23.

    PMID: 29273897DERIVED

  • Rayman G, Kroger J, Bolinder J. Could FreeStyle Libre sensor glucose data support decisions for safe driving? Diabet Med. 2018 Apr;35(4):491-494. doi: 10.1111/dme.13515. Epub 2017 Oct 14.

    PMID: 28945936DERIVED

  • Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016 Nov 5;388(10057):2254-2263. doi: 10.1016/S0140-6736(16)31535-5. Epub 2016 Sep 12.

    PMID: 27634581DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Snr Director, Clinical Development & Regulatory Affairs
Organization
Abbott Diabetes Care
joe.bugler@abbott.com
01993 863164

Study Officials

  • Stephan Matthaei

    Diabetes Center Quakenbruck

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2014

First Posted

September 5, 2014

Study Start

September 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

April 10, 2017

Results First Posted

April 10, 2017

Record last verified: 2017-02

Locations

NL(6)DE(5)AU(6)ES(3)SE(3)