An Evaluation of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes (IMPACT)

Abbott

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Device: Sensor Based Glucose Monitoring System; Device: Standard Blood Glucose Monitoring

Study type: Interventional

Funder types: Industry

Identifiers

NCT02232698

ADC-CI-APO-13019

Details and patient eligibility

About

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.

Enrollment: 328 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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328 participants in 2 patient groups

Sensor Based Glucose Monitoring System

Experimental group

Description:

Standard sensing system use for 6 months.

Treatment:

Device: Sensor Based Glucose Monitoring System

Standard Blood Glucose Monitoring

Active Comparator group

Description:

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

Treatment:

Device: Standard Blood Glucose Monitoring