NCT02232698 - An Evaluation of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes (IMPACT) | Biotech Hunter

Enrollment

328

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

October 31, 2015

Study Completion Date

October 31, 2015

Conditions

Type 1 Diabetes Mellitus

Interventions

DEVICE

Sensor Based Glucose Monitoring System

"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)."

DEVICE

Standard Blood Glucose Monitoring

"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)."

Trial Locations (23)

1090

Klinik fuer Innere Medizin III Medizinische Universitaet Wien, Vienna

1160

Wilhelminenspital Medzin 5, Vienna

5020

Diakonissen-Krankenhaus Salzburg, Salzburg

6020

Medizinische Universität Innsbruck, Innsbruck

6807

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

8036

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

8916

Hospital Germans Trias i Pujol, Badalona

21029

Zentrum für Diabetologie Hamburg Bergedorf, Hamburg

30165

Diabetes-Zentrum Hannover-Nord, Hanover

33206

Clinica Diabetologica, Gijón

48903

Servicio de Endocrinología Hospital Unversitario Cruces, Vizcaya

49610

Diabetes Center Quakenbruck, Quakenbrück

92237

Versdias GmbH, Sūlzbach-Rosenberg

97980

Diabetes Klinik Bad Mergentheim, Bad Mergentheim

1007 MB

Vrije Universiteit Medisch Centrum, Amsterdam

1090 HM

Onze Lieve Vrouwe gasthuis ( OLVG), Amsterdam

4800 RK

Amphia Ziekenhuis, Breda

7909 AA

Bethesda Diabetes Research Center, Hoogeveen

2512 VA

Medisch Centrum Haaglanden, The Hague

3543 AZ

St. Antonius Ziekenhuis, Utrecht

SE-791 29

Falu Lasarett, Falun

SE-171 76

Karolinska Universitetssjukhuset Solna, Solna

SE-141 86

Karolinska Universitetssjukhuset Huddinge, Stockholm