Clinical trial NCT02232698: An Evaluation of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes (IMPACT)
Official title: Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Sensing Technology
Type 1 Diabetes,
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
First posted: 2014-09-05
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with Type 1 diabetes for ≥ 5 years
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:

1. 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)
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.

Primary outcomes:
measure: Time Spent <70 mg/dL
timeFrame: Baseline and Days 194 to 208
Secondary outcomes:
measure: HbA1c at 6 Months
timeFrame: Baseline and Day 208
measure: Time Spent <55 mg/dL and <40 mg/dL
timeFrame: Baseline and Days 194 to 208
measure: Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL
timeFrame: Baseline and Days 194-208
measure: Time Spent >180 mg/dL and >240 mg/dL
timeFrame: Baseline and Days 194 to 208
measure: Time in Range
timeFrame: Baseline and Days 194 to 208
measure: Number of Glucose Measurements Performed
timeFrame: Days 1 to 208
measure: System Utilisation
timeFrame: Days 15 to 208
measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208
timeFrame: Baseline and Day 208
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: VIVIT-Institut am Akad. Lehrkrankenhaus Feldkirch, Innere Medizin und Kardiologie
city: Graz
country: Austria
facility: Medizinische Universität Graz Abteilung für Innere Medizin, Klin. Abteilung für Endokrinologie und Stoffwechsel
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Salzburg
country: Austria
facility: Diakonissen-Krankenhaus Salzburg
city: Wien
country: Austria
facility: Klinik fuer Innere Medizin III Medizinische Universitaet Wien
city: Wien
country: Austria
facility: Wilhelminenspital Medzin 5
city: Bad Mergentheim
country: Germany
facility: Diabetes Klinik Bad Mergentheim
city: Hamburg
country: Germany
facility: Zentrum für Diabetologie Hamburg Bergedorf
city: Hannover
country: Germany
facility: Diabetes-Zentrum Hannover-Nord
city: Quakenbrück
country: Germany
facility: Diabetes Center Quakenbruck
city: Sūlzbach-Rosenberg
country: Germany
facility: Versdias GmbH
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe gasthuis ( OLVG)
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Den Haag
country: Netherlands
facility: Medisch Centrum Haaglanden
city: Hoogeveen
country: Netherlands
facility: Bethesda Diabetes Research Center
city: Utrecht
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Gijon
country: Spain
facility: Clinica Diabetologica
city: Vizcaya
country: Spain
facility: Servicio de Endocrinología Hospital Unversitario Cruces
city: Falun
country: Sweden
facility: Falu Lasarett
city: Solna
country: Sweden
facility: Karolinska Universitetssjukhuset Solna
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Huddinge
Study officials:
affiliation: Diabetes Center Quakenbruck
name: Stephan Matthaei
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.