The primary objective of this study is to demonstrate the impact on time in hypoglycaemia (number of hours per day of hypoglycaemic excursions < 3.9 mmol/L, 70 mg/dL) using the Abbott Sensor Based Glucose Monitoring System compared to Self…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference between the Intervention and Control arm in the number of hours/day
in hypoglycaemia (glucose < 3.9 mmol/L [70 mg/dL]) for the 14 day period at 6
months (Visit 7 to Visit 8).
Secondary outcome
Visit 3 (Day 45) Interim Analysis (Intervention Arm Only)
Difference in TIR defined as 3.9 to 10.0 mmol/L (70 to 180 mg/dL) in the 14 day
period between Days 31 to 45 of Treatment Phase as compared to the Baseline
phase (Days 1 to 15). Safety data will also be analysed and reported (includes
AEs and insertion site signs and symptoms).
Final Analysis (Intervention and Control Arms)
o HbA1c
o Proportion of subjects who achieve time spent in hypoglycaemia (<70 mg/dL) *
1 hour/day
o TIR defined as 3.9 to 10.0 mmol/L, (70 mg/dL to 180 mg/dL)
o Average glucose and glucose variability
o Number and duration of hypoglycaemic episodes (< 3.9 mmol/L, 70 mg/dL);
analysis overall and by both day and night (night defined as between 11 pm and
6 am)
o Number of severe hypoglycaemic episodes (defined as hypoglycaemia episodes
requiring assistance by a third person and/or hospitalisation)
o Number and duration of hypoglycaemic episodes (< 3.1 mmol/L, 55 mg/dL)
o Number and duration of hypoglycaemic episodes (<2.2 mmol/L, 40 mg/dL)
o Number and duration of hyperglycaemic episodes (> 10.0 mmol/L, 180 mg/dL)
o Number and duration of hyperglycaemic episodes (> 13.3 mmol/L, 240 mg/dL)
o Number of events of symptomatic hypoglycaemia
o Post prandial hyperglycaemia (> 10.0 mmol/L, 180 mg/dL)
o Number of episodes of DKA
o Total daily dose of insulin
o Prandial to basal insulin ratio
o Number of subjects changing from once daily to twice daily basal insulin
o Body weight and body mass index
o Fasting cholesterol and triglycerides
o Blood pressure
o User questionnaire (subject [Intervention arm only] and health care
professional facing)
o Quality of Life/Patient Reported Outcome Measures (including Hypoglycaemia
Fear Survey, diabetes treatment satisfaction questionnaire, diabetes distress
scale, and diabetes quality of life)
o Emergency room visits / admissions and non protocol related additional clinic
time
o Medication usage (non insulin related, including glucagon, self reported from
event diary)
o Number of blood glucose finger stick tests performed
o Number of Sensor scans performed (Intervention arm only).
Safety Endpoints
o AEs
o Sensor insertion site signs and symptoms.
Additional Analyses
o Subgroup analysis by MDI and CSII
o All data from the 3 month time point will be analysed and reported for the
primary endpoint and relevant secondary endpoints (excludes questionnaires and
cholesterol and triglyceride measures) at study completion.
Background summary
This medical device is expected to provide a clinical benefit for diabetes
management. Standard blood glucose measurement for patients often painful and
tedious because of the invasive nature. As a result, compliance with the
glucose measurement is often insufficient, leading to a deterioration in
control of the disease. This medical device is a large amount of data gathering
in a much less invasive way. Expected that patients will often perform this
glucose test, learn to anticipate better and faster intervention itself and can
achieve. Better control of their disease
Study objective
The primary objective of this study is to demonstrate the impact on time in
hypoglycaemia (number of hours per day of hypoglycaemic excursions < 3.9
mmol/L, 70 mg/dL) using the Abbott Sensor Based Glucose Monitoring System
compared to Self Monitoring Blood Glucose (SMBG) testing.
Study design
A prospective, multi-centre, randomised, controlled, two arm treatment study to
assess the impact on time in hypoglycaemia (number of hours per day with
hypoglycaemic excursions < 3.9mmol/L, 70 mg/dL) using the Abbott Sensor Based
Glucose Monitoring System.
The treatment period for both arms will be 208 days.
Control arm subjects will have 2 masked Sensor wears (Visits 5 to 6 and Visits
7 to 8)
One scheduled interim analysis of the intervention subjects is planned at the
point when all Intervention arm subjects complete 45 days of study involvement.
(Only time in range [TIR] and safety data (Adverse Events [AEs] and insertion
site signs and symptoms) will be analysed and evaluated at this point).
89 control (SMBG arm) subjects are required to complete the treatment phase of
the study.
89 intervention (Sensor arm) subjects are required to complete the treatment
phase of the study.
A minimum of 224 subjects with Type 1 diabetes are required to be randomised to
obtain a minimum of 178 subjects completing the study. 178 is the minimum
required to detect a difference of 30% (0.3 hours/day at a mean of 1.0
hour/day) in time spent below 3.9 mmol/L (70 mg/dL) at the 6 month time
point.(Day 208).
Subjects are planned to be recruited from approximately 30 sites in the
European Union.
Intervention
For all participating subjects 4x 3mL blooddraw by Venapunction
Study burden and risks
The burden is relatively low and does not differ significantly from normal
burden experienced by the patients of this disease. It is expected that the
load sensor for the group will be even lower than those of their standard
method of diabetes management, in connection with the less invasive nature of
this system. For the control group, there is essentially no difference in
invasiveness compared with the standard treatment. The load consists mainly of
reports (diaries and questionnaires).
Range Road N/A
Witney, Oxon OX29 0YL
GB
Range Road N/A
Witney, Oxon OX29 0YL
GB
Listed location countries
Age
Inclusion criteria
o Diagnosed with Type 1 diabetes for * 5 years
o On their current insulin regimen for * 3 months prior to study entry
o Screening HbA1c result * 7.5% (58 mmol/mol)
o 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
o In the investigator*s opinion the subject is considered technically capable of using the Abbott Sensor Based Glucose Monitoring System
o Aged 18 years or over.
Exclusion criteria
o 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)
o Subject is currently prescribed animal insulin
o Subject is currently prescribed oral steroid therapy or is likely to require oral steroid therapy for any acute or chronic condition during the study
o Has known allergy to medical grade adhesives
o Currently participating in another device or drug study that could affect glucose measurements or glucose management
o Currently using a Continuous Glucose Monitoring (CGM) device or has used one within the previous 4 months
o Currently using Sensor augmented pump therapy
o Is planning to use a CGM device at any time during the study
o A female subject who is pregnant or planning to become pregnant within the study duration
o A breast feeding mother
o Currently receiving dialysis treatment or planning to
receive dialysis during the study
o Has a pacemaker
o Has experienced an acute myocardial infarction within previous 6 months
o 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
o Has experienced an episode of confirmed or suspected diabetic ketoacidosis (DKA) in the previous 6 months
o In the investigator*s opinion, the subject is considered unsuitable for inclusion in the study for any other reason.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL48612.098.14 |