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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02232698
• Date of registration: 03/09/2014
• Prospective Registration: No
• Primary sponsor: Abbott Diabetes Care
• Public title: An Evaluation of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes (IMPACT) IMPACT
• Scientific title: Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes
• Date of first enrolment: September 2014
• Target sample size: 328
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02232698
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Austria, Germany, Netherlands, Spain, Sweden

Contacts

• Name: Stephan Matthaei
• Affiliation: Diabetes Center Quakenbruck

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Type 1 Diabetes Mellitus

Intervention(s)

Device: Sensor Based Glucose Monitoring System

Device: Standard Blood Glucose Monitoring

Primary Outcome(s)

Time Spent <70 mg/dL [Time Frame: Baseline and Days 194 to 208]

Secondary Outcome(s)

HbA1c at 6 Months [Time Frame: Baseline and Day 208]

System Utilisation [Time Frame: Days 15 to 208]

Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL [Time Frame: Baseline and Days 194-208]

Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208 [Time Frame: Baseline and Day 208]

Time Spent <55 mg/dL and <40 mg/dL [Time Frame: Baseline and Days 194 to 208]

Number of Glucose Measurements Performed [Time Frame: Days 1 to 208]

Time Spent >180 mg/dL and >240 mg/dL [Time Frame: Baseline and Days 194 to 208]

Time in Range [Time Frame: Baseline and Days 194 to 208]

Secondary ID(s)

ADC-CI-APO-13019

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 10/04/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02232698