Clinical trial NCT02084498: Advanced Carbohydrate Counting and Automated Bolus Calculation
Official title: A Randomized Controlled Large Study of Flexible Intensified Insulin Therapy (FIIT) With Carbohydrate Counting (CHC) Versus FIIT With Carbohydrate Counting and Automated Bolus Calculation (ABC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Automated bolus calculator (ABC)
Advanced carbohydrate counting (ACC)
Patient empowerment
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
First posted: 2014-03-12
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize, that non-optimally treated carbohydrate counting-naïve patients with type 1 diabetes can achieve better metabolic control by counting carbohydrates, and that the metabolic control can be further improved with concurrent use of Accu-Chek Aviva Expert. Additionally, the investigators propose that carbohydrate counting will lead to better quality of life as a result of fewer restrictions when eating and less variation in blood glucose. Finally the investigators hypothesize that the use of Accu-Chek Aviva Expert will lead to fewer hypoglycemic episodes.


Eligibility criteria: Inclusion Criteria:

* Patients with type 1 diabetes
* Age \>18 years
* Diabetes duration more than 12 months
* Multiple Daily Injections therapy (fast acting analog for meals; long acting analog as basal)
* HbA1c between 8.0% and 11.3%

Exclusion Criteria:

* Present or former practice of carbohydrate counting
* Gastroparesis
* Pregnancy or nursing

Primary outcomes:
measure: Change in HbA1c
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Frequency of serious hypoglycemic events
timeFrame: Baseline, 12 months
Other outcomes:
measure: Frequency of glucose below, in or above target 4-8 mmol/l assessed by blinded Continuous Glucose Monitoring 6 days before study start and 6 days before ending the study
timeFrame: Baseline, 12 months
measure: Frequency of blood glucose measurements assessed by meter download before randomization and at each visit during the study
timeFrame: Baseline, 12 months
measure: Treatment Satisfaction
timeFrame: Baseline, 12 months
Locations:
city: Gentofte
country: Denmark
facility: Steno Diabetes Center
Study officials:
affiliation: Steno Diabetes Center Copenhagen
name: Eva E Hommel, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmidt S, Meldgaard M, Serifovski N, Storm C, Christensen TM, Gade-Rasmussen B, Norgaard K. Use of an automated bolus calculator in MDI-treated type 1 diabetes: the BolusCal Study, a randomized controlled pilot study. Diabetes Care. 2012 May;35(5):984-90. doi: 10.2337/dc11-2044. Epub 2012 Feb 16.
citation: Hommel E, Schmidt S, Vistisen D, Neergaard K, Gribhild M, Almdal T, Norgaard K. Effects of advanced carbohydrate counting guided by an automated bolus calculator in Type 1 diabetes mellitus (StenoABC): a 12-month, randomized clinical trial. Diabet Med. 2017 May;34(5):708-715. doi: 10.1111/dme.13275. Epub 2016 Nov 10.