Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04942756 |
| Other study ID # |
Antea-ARC-21-01 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 30, 2021 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
July 2021 |
| Source |
Antea Foundation |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Cancer patients with known or newly diagnosed (i.e. iatrogenic) Diabetes Mellitus (DM) in
Palliative/Supportive Care will be enrolled. Patients will be randomly assigned to one of two
groups. Patients included in the first group will monitor glucose levels through Continuous
Glucose Monitoring (CGM), using the FreeStyle Libre 2 (FSL2). The second group is represented
by the usual standard way for blood glucose (BG) monitoring (lancing device for finger
samples). An interim analysis is foreseen when the half of the expected events (hyperglycemic
peaks) will be observed. In case the results of interim analysis show superiority of the CGM
(FSL2) group patients of the second group will be switched.
Description:
Diabete Mellitus (DM) represents an emerging factor with an impact on the severity and the
management of symptoms (pain, dyspnoea, fatigue, nausea, vomiting, dehydration) in PC/SC
patients leading to a reduced QoL of patients and family members. It has been noted that
infrequent Blood Glucose (BG) monitoring might result in a not clear definition about whether
symptoms are associated with the dying process or caused by diabetes, leading to inadequate
symptoms management.
It is estimated that more than 30% of PC/SC patients can be affected by DM type I or type II.
The incidence of diabetes seems to be six times greater in cancer patients than in the
general population.
Despite this high incidence, implementation of standard Guidelines on monitoring BG levels in
the PC/SC setting is lacking and the existing Guidelines are mainly based on expert
experience rather than real data obtained from well design studies as evidenced by a recent
review. Currently, the available tool used to evaluate BG in PC/SC patients is mainly
represented by the punctual finger-samples procedure, which is usually performed only when
there is a suspect of hyperglycemia/hypoglycemia or routinely in PC patients with known DM
before meals administration. Punctual finger-samples procedure has many limitations: it is
uncomfortable and painful for patients, it requires training to patients and family members
by Health Care Providers (HCPs) and requires time to HPCs for preparing/conducting the
procedures. As a consequence, BG monitoring in PC/SC patients (especially in home care
settings) with known DM and newly diagnosed DM is very poorly and infrequently performed and
represents a real unmet medical need.
Recently, a very innovative device, Freestyle Libre 2 (FSL2) (Abbott), has obtained a CE mark
for Continuous Glucose Monitoring (CGM) in diabetic patients. The system includes a
self-applied sensor with a size of two-stacked quarters, that is easy to apply on the back of
the upper arm; it employs a pre-calibrated sensor that measures the tissue glucose
concentration repeatedly for two weeks and has a duration of accuracy measurements of 14
consecutive days; interstitial Glucose levels are easily check with a painless one-second
scan by a smartphone App or a Reader with results represented by latest glucose concentration
and trend direction. The scan with the App or the Reader should be applied at least every 8
hours in order to have the recording of the glucose level. FSL2 has real-time glucose alarms
that notify if glucose level is going too low or too high (Free Style Libre 2 User's Manual).
The rationale of the proposed study is based on the CGM system using FSL2, that is highly
matching the need of Glucose level monitoring in PC/SC patients with known or newly diagnosed
(i.e. iatrogenic) DM. FSL2 has no/very little discomfort for patients and it is not painful,
it is easy to apply, it is not time-spending for family members and HCPs and it requires very
brief training for patients and family members. The alarm system of FSL2 can aware patients,
family members and HCPs at any moment when the glucose level is over a predefined cut off
value, allowing to implement the appropriate interventions (i.e. insulin administration or
insulin dose adjustment) in order to prevent and manage Symptomatic hyperglycemia crisis. The
recent International Consensus on Recommendations on CGM data interpretation are showing that
in particularly frail population, Glucose level are maintained for 50% of the time in a range
between 70 mg/dL and 180 mg/dL and for 50% of the time in a range between 180 mg/dl and 250
mg/dl. According to that Recommendations, the alarm could be activated when glucose is over a
cut off level of 180 mg/dL. The alarm activation allows patients themselves, family members,
HCPs to provide patients with the most appropriate intervention (i.e. administration or
adjustment of insulin dosage) in order to prevent glucose level reaching the peak of severe
hyperglycemia (>250 mg/dl).
Similarly, FSL2 allows to monitor Glucose level decrease and to prevent severe hypoglycemic
crisis (BG <50 mg/dL).
On this basis, we would like to evaluate CGM by using FSL2 as a tool for appropriately
managing Glucose levels in PC/SC advanced oncological patients with known or newly diagnosed
DM in order to prevent severe hypoglycemic/hyperglycemic crisis, in comparison to the current
usual procedures (finger samples procedures).
CGM by using FSL2 could have a very positive impact in improving glucose level management in
the PC/SC setting, especially in the home care setting, contributing to an improvement of the
QoL of patients/family members and the HCPs attitude to the importance of glucose level
monitoring. The results of this study could lead to a new standard of care in the management
of patients with advanced cancer with a known/newly diagnosed DM in PC/SC settings.
The study is a multicenter, multinational, randomized, open label, parallel groups study,
conducted in order to show superiority of CGM by using FSL2 in comparison to usual care
procedures (finger samples) in reducing severe hyperglycemic peaks in PC/SC advanced
oncological patients with known/newly diagnosed DM.
An interim analysis is foreseen when the half of the expected events (hyperglycemic peaks)
will be observed. In case the results of interim analysis show superiority of the CGM (FSL2)
group in respect to the control group, patients of the control group will be switched to CGM
by using FSL2 and will be followed until the completion of the study.
