N/A
Completed N=241
An Evaluation of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes (IMPACT)
Source: ClinicalTrials.gov NCT02232698 ↗Enrolled (actual)
241
Serious AEs
3.3%
Results posted
Apr 2017
Primary outcomePrimary: Time Spent <70 mg/dL — 3.38; 3.44; 2.03; 3.27 hours per day — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Spent <70 mg/dL |
3.38; 3.44; 2.03; 3.27 | <0.0001 sig |
| SECONDARY HbA1c at 6 Months |
6.79; 6.78; 6.94; 6.95 | 0.9556 |
| SECONDARY Time Spent <55 mg/dL and <40 mg/dL |
1.59; 1.77; 0.80; 1.65; 0.59; 0.75 | <0.0001 sig |
| SECONDARY Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL |
1.81; 1.67; 1.32; 1.69; 0.96; 0.92 | <0.0001 sig |
| SECONDARY Time Spent >180 mg/dL and >240 mg/dL |
5.62; 5.80; 6.16; 6.08; 1.85; 1.91 | 0.5623 |
| SECONDARY Time in Range |
15.0; 14.8; 15.8; 14.6 | 0.0006 sig |
| SECONDARY Number of Glucose Measurements Performed |
5.5; 5.8; 0.6; 5.6; 15.1; NA | — |
| SECONDARY System Utilisation |
92.8 | — |
| SECONDARY Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208 |
-0.6; 0.5; -0.3; 0.1; 13.4; 7.2 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02232698). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.