|- candidate number||18499|
|- NTR Number||NTR4730|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-jul-2014|
|- Secondary IDs||1436 METC Maxima Medisch Centrum|
|- Public Title||MaxABC study: Effect of Automated Bolus Calculation on glycemic variability and relation with psychological problems|
|- Scientific Title||MaxABC study: Effect of Automated Bolus Calculation on glycemic variability and relation with psychological problems|
|- ACRONYM||sensor BolusCal glucose variabillity welbeiing|
|- Healt Condition(s) or Problem(s) studied||Blood glucose, Blood glucose regulation, Psychological problems|
|- Inclusion criteria||• Subject is ≥ 18 years of age.|
• Patient is diagnosed with Type 1 or Type 2 diabetes.
• HbA1c lies in the range of 48-86 mmol/mol, with either multiple hypoglycemia episodes or large variability as measured by blood glucose self-measurements and participating in the structured BolusCal Education program. 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, consisting of 1-2 injections per day of long-acting basal insulin (Lantus® or Detemir®) and at least 2 injections per day of regular or rapid-acting analogue insulin for meal coverage.
• Subject adjusts meal insulin doses based on carbohydrate content of meals.
• Subject is sub-optimally controlled at investigator’s discretion.
• Patient has the willingness to measure his/her blood glucose level four to seven times a day for a period of 6 months.
• Patient’s Dutch language skills are sufficient for participation in the BolusCal program at investigator’s discretion.
|- Exclusion criteria||• Subject has been diagnosed with any clinically significant condition at investigator’s discretion e.g.:|
o Infectious disease,
o Major organ system disease,
o Psychosis or cognitive impairment,
o Severe or moderate renal impairment, defined by an eGFR <50ml/m/1.73,
o Active proliferative retinopathy.
• Subject is on chemotherapy or radiation therapy (self-reported)
• Subject is pregnant, breast feeding or currently planning a pregnancy.
• Patient is unable to work with a PDA or smartphone, at investigator’s discreation.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-sep-2014|
|- planned closingdate||1-jun-2015|
|- Target number of participants||20|
|- Interventions||BolusCal educational program an sensor |
|- 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 and / 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 daily fluctuations in blood 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 question 2, 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.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| H. Vroenhoven, van|
|- CONTACT for SCIENTIFIC QUERIES|| H. Vroenhoven, van|
|- Sponsor/Initiator ||Máxima Medical Center|
(Source(s) of Monetary or Material Support)
|Maxima Medical Center, Roche Nederland BV|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||18-jul-2014 - 3-sep-2014|