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

Study Overview
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Brief Summary
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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.

Official Title
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Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Device: Sensor Based Glucose Monitoring System
* Device: Standard Blood Glucose Monitoring


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sensor Based Glucose Monitoring System<br>Standard sensing system use for 6 months. | Device: Sensor Based Glucose Monitoring System<br>* Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).<br>|
| Active Comparator: Standard Blood Glucose Monitoring<br>Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration. | Device: Standard Blood Glucose Monitoring<br>* Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time). All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Spent <70 mg/dL | Difference in time <70 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15). | Baseline and Days 194 to 208 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c at 6 Months | Difference in HbA1c between intervention and control group at day 208 adjusting for baseline HbA1c at day 1 | Baseline and Day 208 | 
| Time Spent <55 mg/dL and <40 mg/dL | Difference in time <55 mg/dL & <40 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15). | Baseline and Days 194 to 208 | 
| Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL | Difference in frequency of episodes <70 mg/dL, <55 mg/dL and <40 mg/dL (number per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15). | Baseline and Days 194-208 | 
| Time Spent >180 mg/dL and >240 mg/dL | Difference in time >180 mg/dL and >240 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15). | Baseline and Days 194 to 208 | 
| Time in Range | Difference in time in range 70-180 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15 time in range). | Baseline and Days 194 to 208 | 
| Number of Glucose Measurements Performed | Number of blood glucose fingerstick tests per day by intervention and control group during baseline (days 1 to 15) and days 194 to 208. The number of sensor scans performed performed by the intervention group during days 15 to 208. | Days 1 to 208 | 
| System Utilisation | System utilisation assessed by percentage of sensor glucose data collected by the intervention group | Days 15 to 208 | 
| Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208 | The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (which ranges from -3 (much less satisfied) to +3 (much more satisfied). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied). There is one question to assess the change in perceived frequency of Hypoglycaemia and one question to assess change in perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less of the time now) to +3 (much more of the time now). The ANCOVA adjusts for baseline DTSQs (status version). | Baseline and Day 208 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sensing Technology, Type 1 Diabetes,