To compare the effects on glycemic control, patient reported outcomes (PRO) and experiences (PRE) of rt-CGM with FGM in a real-life outpatient setting among persons with T1D.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is the difference in percentage of time in the hypoglycemic
(defined as glucose < 3.9 mmol/l) range, measured by blinded CGM during the
last week of each treatment phase, between FGM and rt-CGM.
Secondary outcome
Secondary outcomes include changes in glucose control, sensor performance,
changes in clinical parameters, PROs and PREs (including health related quality
of life, treatment satisfaction, fear of hypoglycemia, diabetes distress and
patient preference) during and between both treatment phases.
Background summary
Continuous glucose monitoring (CGM) devices measure glucose concentrations
continuously in the interstitial fluid. CGM currently is considered usual care
for the majority of persons with type 1 diabetes (T1D) and two methods are
available: real-time CGM (rt-CGM) and intermittent / flash glucose monitoring
(FGM). While rt-CGM continuously provides data on glucose concentrations and
(anticipating) alarms at pre-set glucose values, FGM only provides data when
end-users actively read out (scan) their device and provides alarms below a
pre-set value. Previous studies between both methods demonstrated better
outcomes of rt-CGM as compared to FGM, however most of these studies were
performed with FGM without alarm function and did not include patient reported
outcomes (PRO). Given the wide-spread use of both methods, it is of importance
to compare the effects of rt-CGM and FGM.
Study objective
To compare the effects on glycemic control, patient reported outcomes (PRO) and
experiences (PRE) of rt-CGM with FGM in a real-life outpatient setting among
persons with T1D.
Study design
Open-label, prospective, randomized, two-period cross-over study during
real-life circumstances. The intervention phase is two times 28 days,
consecutively. Between the treatment phases is a 7-day wash-out phase. In the
last week of each 28-day treatment phase, participants will wear a blinded CGM
(ipro-2 CGM, Medtronic CGM), to assess the primary outcome. In this study,
GlucoMen® Day CGM (WaveForm Cascade) Continuous Glucose Monitor will be used as
method for rt-CGM. For FGM the FreeStyle LibreTM glucose monitor version 2
(Abbott Diabetes Care Witney, UK), with alarms, will be used.
Study burden and risks
During the 63-day study period participants will be asked to wear the different
sensors and an activity tracker.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- Type 1 diabetes mellitus (as defined by the American Diabetes Association
criteria) for >= 6 months
- Intensive insulin regimen consisting of MDI (basal-bolus with > 3
injections/day) or CSII established for more than 3 months
- Blood glucose control for >= 4 times per day, either using fingerprick
measurements, FSL-FGM or rt-CGM established for more than 3 months
- Age 18 to 75 years
- HbA1c < 10.5 % (91 mmol/mol), as determined - Normal hypoglycemia awareness (Gold score < 4)
- Internet and cellular phone coverage
- Dutch writing and speaking proficiency
- Ability to provide oral and written informed consent
Exclusion criteria
- Oral of injected steroid using within the past 3 months
- Pregnancy or planned pregnancy
- Uncontrolled thyroid disease or uncontrolled hypertension
- Poor visual acuity
- Inability or unwillingness to meet the protocol requirements
- Severe cognitive impairment
- Any severe or uncontrolled medical or psychological condition which, in the
opinion of the investigator, would compromise the ability to meet protocol
requirements.
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 | NL81576.042.22 |