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MaxABC study: Effect of Automated Bolus Calculation on glycemic variability and relation with psychological problems


- candidate number18499
- NTR NumberNTR4730
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-jul-2014
- Secondary IDs1436 METC Maxima Medisch Centrum
- Public TitleMaxABC study: Effect of Automated Bolus Calculation on glycemic variability and relation with psychological problems
- Scientific TitleMaxABC study: Effect of Automated Bolus Calculation on glycemic variability and relation with psychological problems
- ACRONYMsensor BolusCal glucose variabillity welbeiing
- hypothesis
- Healt Condition(s) or Problem(s) studiedBlood 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 Gastroparesis
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 receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-sep-2014
- planned closingdate1-jun-2015
- Target number of participants20
- InterventionsBolusCal educational program an sensor
- Primary outcomeThe 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.
- Timepointsnone
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES H. Vroenhoven, van
- CONTACT for SCIENTIFIC QUERIES H. Vroenhoven, van
- Sponsor/Initiator Máxima Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Maxima Medical Center, Roche Nederland BV
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD18-jul-2014 - 3-sep-2014


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