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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
302
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.
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.
CHU Haut Lévêque
Bordeaux, France
HbA1c at 6 Months
Difference in HbA1c between intervention and control group at day 194 adjusting for baseline HbA1c at day 1 using ANCOVA.
Time frame: Baseline and Day 194
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Days 15 to 208
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Hôpital sainte Marguerite
Marseille, France
CHU Lapeyronie
Montpellier, France
CHU. Nancy
Nancy, France
Hopital Guillaume et René Laennec
Nantes, France
Hospital Lariboisere
Paris, France
Hôpital Cochin
Paris, France
Hôpital Rangueil
Toulouse, France
Diabetes Zentrum Mergentheim
Bad Mergentheim, Germany
Praris Dr Karin Schlecht
Eisenach, Germany
...and 16 more locations
System Utilisation
Sensor utilisation assessed by percentage of sensor glucose data collected by the intervention group.
Time frame: 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).
Time frame: Baseline and Day 194