An Evaluation of a Novel Glucose Sensing Technology in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
To evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on glycaemic control (HbA1c) compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised controlled study design in adults with Type 2 diabetes using insulin.

Official Title
-----------------
Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on HbA1c in Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes Mellitus

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has Type 2 diabetes on insulin therapy for ≥ 6 months and on their current regimen for ≥3 months prior to study entry. Their insulin management must be one of the following; an injection regimen of prandial insulin at least once daily, or, prandial insulin at least once daily plus basal insulin at least once daily, or, continuous subcutaneous insulin infusion (CSII) with no plans to change during the study. HbA1c result ≥7.5% (58 mmol/mol) and ≤12.0% (108 mmol/mol) on entry to the study. Reports self-testing of blood glucose levels on a regular basis equivalent to a minimum of 10 tests per week, 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. In the Investigator's opinion the subject is proactive and therefore willing to modify their diabetes management Aged 18 years or over. Exclusion Criteria: Insulin regimen consists entirely of basal or includes bi-phasic insulin. Subject is currently prescribed animal insulin. Subject is currently prescribed steroid therapy or is likely to require 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. Is planning to use a CGM device at any time during the study. Total daily dose of insulin (TDD) is >1.75iu/kg at entry to the study. A female subject who is pregnant or planning to become pregnant within the study duration. Currently receiving dialysis treatment or planning to receive dialysis during the study. Has experienced an acute myocardial infarction within previous 6 months. Has a concomitant disease or condition that may compromise patient safety, including unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any other uncontrolled medical condition. Has a pacemaker or any other neuro stimulators. Has experienced any episode of severe hypoglycaemia, requiring third party assistance and/or admission to hospital, in the previous 6 months. Has experienced any episode of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycaemic state (HHS) in the previous 6 months. In the investigator's opinion, the subject is considered as unsuitable for inclusion in the study for any other reason.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 system use for 6 months. Followed by open access to the device 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. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.<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 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c at 6 Months | Difference in HbA1c between intervention and control group at day 194 adjusting for baseline HbA1c at day 1 using ANCOVA. | Baseline and Day 194 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) using ANCOVA. | Baseline and Days 194 to 208 | 
| Time Spent <70 mg/dL and <55 mg/dL | Difference in time <70 mg/dL and <55 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) using ANCOVA. | Baseline and Days 194 to 208 | 
| Frequency of Episodes <70 mg/dL and <55 mg/dL | Difference in frequency of episodes <70 mg/dL and <55 mg/dL (number per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) using ANCOVA. | Baseline and Days 194 to 208 | 
| Time Spent >180 mg/dL and >240 mg/dL | Difference in time >180 mg/dL and >240mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) using ANCOVA. | 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 days 15 to 208. The number of sensor scans performed by the intervention group during days 15 to 208. | Days 15 to 208 | 
| System Utilisation | Sensor 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 194. | 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 194 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sensing Technology, Type 2 Diabetes,