The purpose of the present study is to test whether a structured Bolus Calculation education program and subsequent use of the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor can improve glycemic control in diabetes…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The purpose of the present study is to test whether a structured Bolus
Calculation education program and subsequent use of the Accu-Chek® Aviva Expert
with an integrated bolus advisor can improve glycemic control in carbohydrate
counting-patients with type 1 or type 2 diabetes mellitus with suboptimal
glycemic control. Additionally, we will asses if the BolusCal concept leads to
improvements in various patient reported outcomes such as quality of life,
treatment satisfaction and fear of hypoglycemia.
Secondary outcome
To determine if measurements of daily glucose levels are associated with
psychological factors (mood, anxiety, energy level). And if so, which glucose
measurements are related to which psychological factors
To determine if, in case an association is found for the question above, the
type of diabetes is an effect modificator.
To determine if patients with depressive disorders and/or other long term
psychological problems have greater glucose fluctuations or other differences
in glucose measurements.
Background summary
Diabetes mellitus is a chronic condition with a major impact on day-to-day
life. Optimal glycemic control is very important for reducing risk of
complications but requires a high degree of self-management for patients on
insulin therapy. Carbohydrate counting combined with a structured education
program can help improve glycemic control. For this reason the BolusCal
Education program has been launched in the Netherlands for diabetes patients on
multiple daily injection therapy.
Until recently, the best measure of glycemic control was HbA1c. Nowadays we can
measure glucose control with continuous glucose monitoring. A validated
interpretation of these measurements however is not yet available. Moreover, it
is still unclear to what extent fluctuations in blood glucose levels are
related to various psychological factors concerning quality of life. In order
to optimize diabetes treatment, further insight has to be gained in the impact
of daily glucose regulation on various aspects of patients* well-being.
Study objective
The purpose of the present study is to test whether a structured Bolus
Calculation education program and subsequent use of the Accu-Chek® Aviva Expert
blood glucose meter with an integrated bolus advisor can improve glycemic
control in diabetes patients. We will also asses if the BolusCal concept leads
to improvements in various patient reported outcomes concerning quality of life
and if this is related to measures of glucose control as measured with
continuous glucose measurement.
Study design
single center 16-week intervention pilot study
Intervention
study subjects will participate in the BolusCal education program: a structured
program concerning insulin dose adjustment based on carbohydrate counting with
the use of a personalized automated bolus calculator.
Study burden and risks
There are no direct benefits for study subjects. The BolusCal program is
considered regular care and is therefore also available to patients who chose
not to participate in this study.
Risk associated with this study is minimal. Risk of infection at insertion of
the sensor needle is present but low. Risk of hypoglycemia is minimal and not
increased compared to regular care.
The burden for the patient consists of carrying the CGM sensor twice for a
week. During CGM, patients will fill out a lifestyle diary. Psychological
questionnaires have to be filled in twice. During the entire study a
hypoglycemia diary will be kept and glucose will be measured 4 to 7 times a
day. 6 hospital visits in 16 weeks are necessary for participation. Blood is
drawn twice at baseline and 16 weeks for HbA1C measurement.
ds th fliednerstraat 1
Eindhoven 5631 BM
NL
ds th fliednerstraat 1
Eindhoven 5631 BM
NL
Listed location countries
Age
Inclusion criteria
* Subject is * 18 years of age.
* Patient is diagnosed with Type 1 or Type 2 diabetes, with an HbA1c in the range of 48-86 mmol/mol, with either multiple hypoglycemia episodes (defined as >1 per month) or large daily variability. HbA1c has remained stable within a range of 12 mmol/mol in the year prior to inclusion.
* Subject has had diabetes for >12 months.
* Subject has been on Multiple Daily Injections (MDI) insulin therapy for at least 6 months
* Subject adjusts meal insulin doses based on carbohydrate content of meals.
* Subject is sub-optimally controlled at investigator*s discretion.
Exclusion criteria
* Subject has been diagnosed with any clinically significant condition at investigator*s discretion e.g. infectious disease, major organ system disease, Gastroparesis, Psychosis or cognitive impairment, severe or moderate renal impairment, defined by an eGFR <50ml/m/1.73, active proliferative retinopathy.
* Subject is on chemotherapy or radiation therapy (self-reported)
* Subject is pregnant, breast feeding or currently planning a pregnancy (self-reported).
* Patient is unable to work with a PDA and or smartphone at investigator*s discreation.
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 |
|---|---|
| Other | aangevraagd |
| CCMO | NL48235.015.14 |