The objective of the study is to evaluate the (cost-)effectiveness of a stepped-care approach starting with HypoAware, compared with CGM in type 1 diabetes patients with an impaired awareness of hypoglycemia.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Frequency of (self-reported) severe hypoglycemia.
Secondary outcome
Quality adjusted life years (QALYs) and societal costs consisting of costs of
healthcare consumption, informal care and lost productivity; hypoglycemia
awareness (Gold score); frequency of mild hypoglycemia; glycosylated hemoglobin
(HbA1c); psychological well-being: fear of hypoglycemia (Hypoglycemia Fear
Survey (HFS-II)), diabetes-related distress (PAID); and results from the
diagnostic glucose sensor and results from patients wearing a continuous
glucose monitoring(CGM device/Freestyle Libre/(insulin pump): time spent in the
euglycemic range (interstitial glucose >3.9-<10.0 mmol/L), sensor-derived
hypoglycaemic events, nocturnal hypoglycemia, area under curve (AUC) <=3.9
mmol/L and glucose variability, calculated as Mean Of Daily Differences (MODD)
and Continuous Overall Net Glycemic Action (CONGA).
The information from the CGM/FSL/insulin pump upload will be gathered as
follows: the physician or researcher will ask the participant*s permission to
download an upload from the participant*s CGM/FSL/insulin pump account, in
order to transfer the relevant information to a coded research database. In the
upload the physician or researcher will erase/cover all personal data and
replace it with the participant*s code, before it is sent to the coordinating
researcher.
The information from the diabetes diaries, that are kept during the blind
sensor week, will be recorded in retrospect in the programme used to upload the
blind sensor.
Background summary
Events of severe hypoglycemia (requiring third party assistance) adversely
affect quality of life, and lead to significant morbidity and high societal
costs in people with type 1 diabetes mellitus. Both the HypoAware approach, a
blended (group and online) psycho-educational intervention based on the
evidence-based Blood Glucose Awareness Training (BGAT), and continuous glucose
monitoring (CGM) help patients get their blood glucose into the target range
for more of the day and prevent hypoglycemic event rates in up to 50% of people
with impaired awareness of hypoglycemia. We hypothesize that a stepped-care
approach starting with HypoAware, and adding CGM as needed, is more effective
in reducing the number of severe hypoglycemic events, in comparison with CGM
alone in type 1 diabetes patients with an impaired awareness of hypoglycemia.
Additionally, we believe the stepped-care approach will be more cost-effective
compared to CGM.
Study objective
The objective of the study is to evaluate the (cost-)effectiveness of a
stepped-care approach starting with HypoAware, compared with CGM in type 1
diabetes patients with an impaired awareness of hypoglycemia.
Study design
A two-arm, multicenter cluster randomized controlled trial and economic
evaluation.
Intervention
Stepped-care approach, initially with structured diabetes education (step 1,
HypoAware), progressing to CGM (step 2) if after 6 months hypoglycemia
unawareness has not improved or a severe hypoglycemic event occurs.
This will be compared with CGM.
Study burden and risks
Both HypoAware and CGM are already part of regular clinical care, but there is
currently no standard or preferred intervention. There are no known risks
associated with following the HypoAware course. The only potential risk
associated with (RT-)CGM use is the chance of false hypoglycemic alerts.
Although this may be unpleasant for patients, the risk of this evolving into a
dangerous situation is minimal and therefore an acceptable risk. Furthermore,
if such an event has taken place patients will report this to their diabetes
nurse or doctor for further inspection.
Patients in both the Stepped Care and CGM group could benefit from both
interventions in preventing severe hypoglycemia and improving their
hypoglycemia awareness. Therefore, we believe there is minimal risk in this
trial.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
- 18 years or older
- Type 1 diabetes, treated with either continuous subcutaneous insulin infusion
(CSII) or multiple daily insulin injections (MDI)
- Impaired awareness of hypoglycemia, as defined by at least one of the
following criteria: Gold criteria (i.e., with a Gold score >=4), or one or more
severe hypoglycemic events (defined as events requiring external assistance)
the past two years
Exclusion criteria
- Renal insufficiency, with glomerular filtration rate (GFR) < 30 mL/min
- History of myocardial infarction in the last 3 months
- Current untreated proliferative diabetic retinopathy
- Current (treatment for) malignancy
- Current severe psychiatric disorders, in the opinion of the investigator
- Current substance abuse or alcohol abuse (men >21 units/week, women >14
units/week)
- Pregnancy or pregnancy wish
- Current use of FreeStyle Libre, acquired < 3 months prior to screening for
problems with hypoglycemia*s
- Any hearing or vision impairment that could hinder perception of the glucose
display and alarms, or otherwise incapable of using a (RT-)CGM, in the opinion
of the investigator
- Poor command of the Dutch language or any (mental) disorder that precluded
full understanding of the purpose and instructions of the study
- No accessibility to a computer
- Any known or suspected allergy to trial-related products
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL64474.029.18 |
| OMON | NL-OMON29063 |