An Evaluation of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes (IMPACT)
NCT ID: NCT02232698
Last Updated: 2017-04-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
328 participants
INTERVENTIONAL
2014-09-30
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Sensor Based Glucose Monitoring System
Standard sensing system use for 6 months.
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).
Standard Blood Glucose Monitoring
Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
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).
Interventions
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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).
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).
Eligibility Criteria
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Inclusion Criteria
2. On their current insulin regimen for ≥ 3 months prior to study entry
3. Screening HbA1c result ≤ 7.5% (58 mmol/mol)
4. 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
5. In the investigator's opinion the subject is considered technically capable of using the Abbott Sensor Based Glucose Monitoring System
6. Aged 18 years or over.
Exclusion Criteria
2. Subject is currently prescribed animal insulin
3. Subject is currently prescribed oral steroid therapy or is likely to require oral steroid therapy for any acute or chronic condition during the study
4. Has known allergy to medical grade adhesives
5. Currently participating in another device or drug study that could affect glucose measurements or glucose management
6. Currently using a Continuous Glucose Monitoring (CGM) device or has used one within the previous 4 months
7. Currently using Sensor augmented pump therapy
8. Is planning to use a CGM device at any time during the study
9. A female subject who is pregnant or planning to become pregnant within the study duration
10. A breast feeding mother
11. Currently receiving dialysis treatment or planning to receive dialysis during the study
12. Has a pacemaker
13. Has experienced an acute myocardial infarction within previous 6 months
14. 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
15. Has experienced an episode of confirmed or suspected diabetic ketoacidosis (DKA) in the previous 6 months
16. In the investigator's opinion, the subject is considered unsuitable for inclusion in the study for any other reason.
18 Years
ALL
No
Sponsors
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Abbott Diabetes Care
INDUSTRY
Responsible Party
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Principal Investigators
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Stephan Matthaei
Role: PRINCIPAL_INVESTIGATOR
Diabetes Center Quakenbruck
Locations
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VIVIT-Institut am Akad. Lehrkrankenhaus Feldkirch, Innere Medizin und Kardiologie
Feldkirch, , Austria
Medizinische Universität Graz Abteilung für Innere Medizin, Klin. Abteilung für Endokrinologie und Stoffwechsel
Graz, , Austria
Medizinische Universität Innsbruck
Innsbruck, , Austria
Diakonissen-Krankenhaus Salzburg
Salzburg, , Austria
Klinik fuer Innere Medizin III Medizinische Universitaet Wien
Vienna, , Austria
Wilhelminenspital Medzin 5
Vienna, , Austria
Diabetes Klinik Bad Mergentheim
Bad Mergentheim, , Germany
Zentrum für Diabetologie Hamburg Bergedorf
Hamburg, , Germany
Diabetes-Zentrum Hannover-Nord
Hanover, , Germany
Diabetes Center Quakenbruck
Quakenbrück, , Germany
Versdias GmbH
Sūlzbach-Rosenberg, , Germany
Vrije Universiteit Medisch Centrum
Amsterdam, , Netherlands
Onze Lieve Vrouwe gasthuis ( OLVG)
Amsterdam, , Netherlands
Amphia Ziekenhuis
Breda, , Netherlands
Bethesda Diabetes Research Center
Hoogeveen, , Netherlands
Medisch Centrum Haaglanden
The Hague, , Netherlands
St. Antonius Ziekenhuis
Utrecht, , Netherlands
Hospital Germans Trias i Pujol
Badalona, , Spain
Clinica Diabetologica
Gijón, , Spain
Servicio de Endocrinología Hospital Unversitario Cruces
Vizcaya, , Spain
Falu Lasarett
Falun, , Sweden
Karolinska Universitetssjukhuset Solna
Solna, , Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm, , Sweden
Countries
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References
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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.
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.
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.
Other Identifiers
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ADC-CI-APO-13019
Identifier Type: -
Identifier Source: org_study_id
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