The overall aim of this study is to better understand the impact of symptomatic and asymptomatic episodes of hypoglycaemia on people living with diabetes.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Determine the Low Interstitial Glucose (LIG) parameters that have the optimum
performance for detection and identification of patient-reported-hypoglycemia
(PRH); *LIG*_PRH (h_opt,t_opt).
Secondary outcome
Impact of symptomatic and asymptomatic hypoglycaemia on different domains of
Quality of Life (QoL) and health economic variables.
Background summary
Hypoglycaemia or low blood glucose, and its fear are major barriers to
achieving optimal glucose control. New technology, such as continuous glucose
monitors (CGM), help us to better identify hypoglycaemia and develop strategies
to avoid it. These devices measure glucose in the skin, rather than in the
blood, and provide information not only on how low glucose is, but also for how
long. Recent studies showed that over half of episodes of low glucose with
these systems are not recognised by people with diabetes, and even people
without diabetes have sensor values that are below the current thresholds for
hypoglycaemia [low blood glucose] that we measure with traditional monitors.
In this study, we will evaluate the impact of symptomatic as well as
asymptomatic episodes of low sensor glucose on a variety of clinical, patient
related and health economic outcomes such as mood, quality of sleep and
productivity. We will test different levels and durations of low sensor glucose
to identify the one that best matches episodes that are symptomatic to help us
best define hypoglycaemia using these systems.
We will also look at factors that influence this such as sleep or activity as
well as diabetes management behaviours (such as insulin dosing, carb counting,
etc). At the end of this study, we will be able to provide a better definition
of clinically relevant low sensor glucose readings that we hope will help
inform clinical as well as academic interpretation of CGM data.
Study objective
The overall aim of this study is to better understand the impact of symptomatic
and asymptomatic episodes of hypoglycaemia on people living with diabetes.
Study design
This is a multinational multicentre observational study designed to identify
the continuous glucose monitoring parameters [ threshold and duration] that
best correlate with episodes of patient reported hypoglycaemia.
We will also then look at the impact of these episodes of hypoglycaemia on
biological, quality of life and health economic outcomes.
Participants will be recruited from 8 centres across Europe and after informed
consent, will complete a series of baseline questionnaires and baseline blood
samples. They will undergo 10 weeks of blinded continuous glucose monitoring
during which they will use a bespoke app on a smartphone to answer questions
about any hypoglycaemia they may have experienced, along with questions about
various domains of quality of life and productivity that may be affected by
diabetes. The app will ask them this series of questions once on waking, once
in mid-afternoon and once before bed, every day. During the study period, they
will continue with usual diabetes management and their usual method of glucose
monitoring. They will also wear an activity tracker that will provide
information on their sleep and activity.
Data will be anonymised and downloaded onto the study database at the end of
the 10-week period for analysis. Participants will be seen once more, 1 year
after recruitment to repeat the questionnaires they completed at baseline. We
will also collect some blood samples at their three main visits.
Study burden and risks
The trial will be conducted in accordance with the current approved protocol,
GCP, relevant regulations and standard operating procedures. A risk assessment
and monitoring plan will be prepared before the study opens and will be
reviewed as necessary over the course of the trial to reflect significant
changes to the protocol or outcomes of monitoring activities.
This is a very low risk study in which an adverse event occurring as a direct
consequence of taking part in the study is unlikely as there is no intervention.
Wearing a glucose sensor can be minimally irritating (skin irritation due to
adhesion film, bruising when inserting the sensor), but these devices are being
used in routine diabetes care with minimal problems.
Monitoring one's hypoglycaemia events and quality of life on a smart phone app
may be a new experience for some. This level of self-reflection may cause
distress but at the same time may help in discussing diabetes problems with the
clinicians more effectively.
Data protection: all downloads from devices (CGMS and App) will be anonymised,
as it will be the case for all data obtained in this study.
Geert Grooteplein Zuid 8 Geert Grooteplein Zuid 8
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 8 Geert Grooteplein Zuid 8
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
1. Age 18 - 85 years
2. HbA1c 5 * 10% [31 * 86 mmol/mol]
3. Confirmed diagnosis of type 1 or type 2 diabetes
4. Using > 1 injection of insulin / day or insulin pump.
5. Ability to provide written informed consent
6. Performing regular SMBG [ > 1 / day on a 4-week download] . For those using
flash or continuous glucose monitoring, this should be used at least 70% of the
time.
7. At least 1 episode of hypoglycaemia [ either biochemical or symptomatic] in
the last month
8. On stable therapy for at least 3 months.
9. Willing to complete study procedures including wearing the Fitbit and CGM
devices and completing the EMA questionnaires on the uMotif app three times a
day for 10 weeks ( we expect minimum 80% data completeness)
Exclusion criteria
1. Concurrent conditions that can affect glucose readings [renal impairment GFR
< 30 ml/min, hepatic impairment, untreated adrenal or thyroid insufficiency, as
judged by the investigator.
2. Severe cognitive impairment or psychological illness that can impair
performance of EMA tasks, visual impairment that will preclude use of the EMA
or sensors.
3. Severe psychiatric / psychological illness including extreme fear of hypo-
or hyper- glycaemia ( in the opinion of the investigator)
4. Pregnant or plans for pregnancy in the next 6 months
5. Use of automated insulin delivery systems such as closed loop or automated
threshold suspend or predictive low glucose suspend insulin pumps.
6. Known allergies to adhesives required for the CGM systems
7. People who work regular night shifts
8. Any other condition which in the opinion of the study team would impair
their ability to complete the study
Design
Recruitment
Medical products/devices used
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 | NL73044.091.20 |
| Other | Volgt |