Status:
COMPLETED
An Evaluation of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes (IMPACT)
Lead Sponsor:
Abbott Diabetes Care
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
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 co...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- In the investigator's opinion, the subject is considered unsuitable for inclusion in the study for any other reason.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT02232698
Start Date
September 1 2014
End Date
October 1 2015
Last Update
April 10 2017
Active Locations (23)
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1
VIVIT-Institut am Akad. Lehrkrankenhaus Feldkirch, Innere Medizin und Kardiologie
Feldkirch, Austria, 6807
2
Medizinische Universität Graz Abteilung für Innere Medizin, Klin. Abteilung für Endokrinologie und Stoffwechsel
Graz, Austria, 8036
3
Medizinische Universität Innsbruck
Innsbruck, Austria, 6020
4
Diakonissen-Krankenhaus Salzburg
Salzburg, Austria, 5020