Type 1 DiabetesNCT02084498
Advanced Carbohydrate Counting and Automated Bolus Calculation
A study testing Automated bolus calculator and Advanced Carbohydrate Counting in people with Type 1 Diabetes, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Automated bolus calculator and Advanced Carbohydrate Counting
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2012to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- Present or former practice of carbohydrate counting
- Gastroparesis
- Pregnancy or nursing
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Type 1 Diabetes
- Being tested
- Automated bolus calculator, Advanced Carbohydrate Counting
- Keywords
- Automated bolus calculator (ABC), Advanced carbohydrate counting (ACC), Patient empowerment
- Medical subject headings
- Diabetes Mellitus, Type 1, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated bolus calculatorDevice
Also called Accu-Chek Aviva Expert, Roche Diagnostics
Training in Advanced Carbohydrate Counting and the use of an automated bolus calculator according to the BolusCal concept.
Advanced Carbohydrate CountingBehavioural
Training in advanced carbohydrate counting.
| Study group | Role | What they receive |
|---|---|---|
| ACC | Active comparator | Training in advanced carbohydrate counting Receives: Behavioral: Advanced Carbohydrate Counting |
| ACC + ABC | Experimental | Training in advanced carbohydrate counting plus the use of an automated bolus calculator. Receives: Device: Automated bolus calculator; Behavioral: Advanced Carbohydrate Counting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Measured: Baseline, 12 months
Secondary outcomes (1)
Frequency of serious hypoglycemic events
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startSep 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital
- Responsible party
- Principal investigator, Eva Hommel, Steno Diabetes Center Copenhagen
- Investigators
- Eva E Hommel, MD, DMSc, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084498
- Sponsor's protocol ID
- StenoABC
- Status last verified
- Nov 2014
- First submitted
- 24 Feb 2014
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22344610Hommel 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.
PubMed 27761942
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02084498
- Acronym / sponsor ID
- StenoABC
- Conditions
- Type 1 Diabetes
- Keywords
- Automated bolus calculator (ABC), Advanced carbohydrate counting (ACC), Patient empowerment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- Sep 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 12 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACC | Active comparator | Behavioral: Advanced Carbohydrate CountingTraining in advanced carbohydrate counting |
| ACC + ABC | Experimental | Device: Automated bolus calculator, Behavioral: Advanced Carbohydrate CountingTraining in advanced carbohydrate counting plus the use of an automated bolus calculator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (3 listed)
- Present or former practice of carbohydrate counting
- Gastroparesis
- Pregnancy or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated bolus calculatorAlso: Accu-Chek Aviva Expert, Roche DiagnosticsTraining in Advanced Carbohydrate Counting and the use of an automated bolus calculator according to the BolusCal concept. | Device | ACC + ABC |
| Advanced Carbohydrate CountingTraining in advanced carbohydrate counting. | Behavioural | ACC, ACC + ABC |
Primary outcome
Change in HbA1c
Time frame: Baseline, 12 months
1 secondary outcome
Frequency of serious hypoglycemic events
Time frame: Baseline, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
- Background: PubMed 22344610Schmidt 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.
- Derived from this study: PubMed 27761942Hommel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva E Hommel, MD, DMSc principal investigator
Steno Diabetes Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated bolus calculator and Advanced Carbohydrate Counting in people with Type 1 Diabetes, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: Baseline, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02084498, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2014.