Type 1 DiabetesNCT01223547
Study of the Effects of Carbohydrate Counting
A study testing Education in people with Type 1 Diabetes, run by Hvidovre University Hospital 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 an integrated glucose meter and bolus calculator. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2010to Aug 2011
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes
- Diabetes duration at least 12 months
- MDI therapy
- HbA1c 8-10,5% (both included)
Who cannot join
- Gastroparesis
- Present or former practice of carbohydrate counting
- Pregnancy or nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Carbohydrate Counting and Bolus Calculation Using an Electronic Calculator in Carbohydrate Counting-naïve Persons With Non-optimally Treated Type 1 Diabetes
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 an integrated glucose meter and bolus calculator. The investigators want to test the hypothesis in this study.
- Conditions
- Type 1 Diabetes
- Being tested
- Education
- Keywords
- Carbohydrate counting, Insulin bolus calculation
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Participants are taught the principles of carb counting
EducationOther
Also called The integrated glucose meter and bolus calculator: Aviva Expert, Roche
Participants are taught the principles of carb counting and the use of the integrated glucose meter and bolus calculator.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Participants in this arm continues their usual insulin therapy |
| Carb counting | Active comparator | Participants in this arm are taught carb counting Receives: Other: Education |
| Carb counting and bolus calculator | Active comparator | Participants in this arm are taught carb counting and are provided with an integrated glucose meter and bolus calculator. Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Measured: 4 months
Secondary outcomes (5)
Variation in blood glucose
Measured by CGM
Measured: 4 months
Number of hypoglycemic events
BG < or = 2.8 and/or unconsciousness
Measured: 4 months
Treatment satisfaction
Questionnaires
Measured: 4 months
Total daily insulin dose
Measured: 4 months
Weight
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Council for Strategic Research, Medtronic, Roche Pharma AG, Novo Nordisk A/S
- Responsible party
- Principal investigator, Signe Schmidt, Hvidovre University Hospital
- Investigators
- Signe Schmidt, MD, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223547
- Sponsor's protocol ID
- BOLUSCAL
- Status last verified
- Jan 2014
- First submitted
- 18 Oct 2010
- Last updated
- 28 Jan 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 22344610
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Carbohydrate Counting and Bolus Calculation Using an Electronic Calculator in Carbohydrate Counting-naïve Persons With Non-optimally Treated Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01223547
- Acronym / sponsor ID
- BOLUSCAL
- Conditions
- Type 1 Diabetes
- Keywords
- Carbohydrate counting, Insulin bolus calculation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- The Danish Council for Strategic Research, Medtronic, Roche Pharma AG, Novo Nordisk A/S
- Study start
- Oct 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 19 Oct 2010 (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 an integrated glucose meter and bolus calculator. The investigators want to test the hypothesis in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Participants in this arm continues their usual insulin therapy |
| Carb counting | Active comparator | Other: EducationParticipants in this arm are taught carb counting |
| Carb counting and bolus calculator | Active comparator | Other: EducationParticipants in this arm are taught carb counting and are provided with an integrated glucose meter and bolus calculator. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 diabetes
- Diabetes duration at least 12 months
- MDI therapy
- HbA1c 8-10,5% (both included)
Key exclusion criteria (3 listed)
- Gastroparesis
- Present or former practice of carbohydrate counting
- 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 |
|---|---|---|
| EducationParticipants are taught the principles of carb counting | Other | Carb counting |
| EducationAlso: The integrated glucose meter and bolus calculator: Aviva Expert, RocheParticipants are taught the principles of carb counting and the use of the integrated glucose meter and bolus calculator. | Other | Carb counting and bolus calculator |
Primary outcome
Change in HbA1c
Time frame: 4 months
5 secondary outcomes
Variation in blood glucose
Time frame: 4 months
Number of hypoglycemic events
Time frame: 4 months
Treatment satisfaction
Time frame: 4 months
Total daily insulin dose
Time frame: 4 months
Weight
Time frame: 4 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 28 Jan 2014.
- Derived from this study: 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.
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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.
Signe Schmidt, MD principal investigator
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Type 1 Diabetes, run by Hvidovre University Hospital 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 4 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 28 Jan 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: 4 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 NCT01223547, which also lists 1 linked publication.
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 28 Jan 2014.