Type 1 Diabetes MellitusNCT01677546
Bolus Calculator and Wireless Communication With Blood Glucose Meter in Management of Type 1 Diabetes Mellitus (T1DM).
A study testing CSII+BC+CL and CSII+BC in people with Type 1 Diabetes Mellitus, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Bolus calculator (BC) is one of the advanced functions in modern insulin pumps (CSII)models. Together with wireless communication with blood glucose meter potentially facilitates achieving the target post prandial glucose levels. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- CSII+BC+CL and CSII+BC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2011to Jul 2012
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 7- 18 years old
- type 1 diabetes mellitus for over 1 year
- treatment with insulin pump with bolus calculator function
- HbA1c < 10%
- expressed written informed consent
Who cannot join
- recall the consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Insulin Pump Bolus Calculator and Wireless Communication With Blood Glucose Meter on Metabolic Control in Children With Type 1 Diabetes Mellitus - Randomised Control Trial
Bolus calculator (BC) is one of the advanced functions in modern insulin pumps (CSII)models. Together with wireless communication with blood glucose meter potentially facilitates achieving the target post prandial glucose levels. In this RCT authors assessed whether use of wireless communication between compatible devices: MiniMed insulin pump and blood glucose meter Contour Link (CL), Bayer results in more frequently bolus calculator using and what is the impact of exerting this tool on metabolic control in type 1 diabetic patients.
Read the detailed description
In this RCT 156 patients were randomly assigned to one of the 3 arms: group A- subjects using insulin pump bolus calculator wirelessly connected with blood glucose meter, group B- subjects using insulin pump bolus calculator without wireless communication with blood glucose meter or group C- insulin pump, without bolus calculator function. We compared the glycated hemoglobin levels and post- prandial hypoglycaemia after 3 months of observation between the groups. We also assessed secondary endpoints (mentioned above).
Patients were estimated at three time points: at the beginning, after 6 weeks and after 3 months of intervention. Investigators performed computer reports at each visit, with Medtronic CareLink Pro software.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- CSII+BC+CL, CSII+BC
- Keywords
- diabetes, insulin pump, bolus calculator, Contour Link
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSII+BC+CLDevice
Also called Insulin pump, bolus calculator, bolus Wizard, Contour Link
Insulin pump bolus calculator wirelessly communicated with blood glucose meter (Contour Link)
CSII+BCDevice
Also called Insulin pump, bolus calculator, bolus Wizard
Insulin pump bolus calculator without wireless communication with blood glucose meter (Contour Link)
| Study group | Role | What they receive |
|---|---|---|
| CSII+BC+CL | Experimental | Patients using insulin pump (CSII) bolus calculator (BC) wirelessly connected with blood glucose meter Contour Link (CL) Receives: Device: CSII+BC+CL |
| CSII+BC | Experimental | Patients using insulin pump (CSII) bolus calculator (BC) without wireless connection with blood glucose meter (CL) Receives: Device: CSII+BC |
| CSII (insulin pump only) | No intervention | Patients using insulin pump (CSII) without BC and connection with CL |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c (Glycated hemoglobin)
Measured: 3 months
Secondary outcomes (7)
Post- prandial glycaemia
Post- prandial glycaemia is express as a mean post- prandial glycaemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days
Measured: 2 hours after the meals
Treatment satisfaction
Simple questions regarded treatment satisfaction and wish to continuation.
Measured: 3 months
Hypoglycaemia episodes and severe hypoglycaemia events
Hypoglycaemia defined as glycaemia below 70 mg/dl and, separately, glycaemia below 50 mg/dl.
Measured: 3 months
Frequency of self- blood glucose monitoring
Number of self- blood glucose monitoring per day
Measured: 3 months
Hyperglycaemic episodes
Hyperglycaemia defined as glycaemia above 180 mg/dl
Measured: 3 months
Frequency of meal boluses
Number of meal boluses per day
Measured: 3 months
Frequency of bolus calculator using
Number of bolus calculator use per day
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startJan 2011
- Primary completionJul 2012
- Study completionJul 2012
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 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agnieszka Szypowska, A. Professor, Study chair, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677546
- Sponsor's protocol ID
- Bolus-calculator
- Status last verified
- Aug 2012
- First submitted
- 22 Aug 2012
- Last updated
- 3 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Ramotowska A, Szypowska A. Bolus calculator and wirelessly communicated blood glucose measurement effectively reduce hypoglycaemia in type 1 diabetic children - randomized controlled trial. Diabetes Metab Res Rev. 2014 Feb;30(2):146-53. doi: 10.1002/dmrr.2477.
PubMed 24115314
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Insulin Pump Bolus Calculator and Wireless Communication With Blood Glucose Meter on Metabolic Control in Children With Type 1 Diabetes Mellitus - Randomised Control Trial
- ClinicalTrials.gov ID
- NCT01677546
- Acronym / sponsor ID
- Bolus-calculator
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- diabetes, insulin pump, bolus calculator, Contour Link
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 3 Sep 2012 (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.
Bolus calculator (BC) is one of the advanced functions in modern insulin pumps (CSII)models. Together with wireless communication with blood glucose meter potentially facilitates achieving the target post prandial glucose levels. In this RCT authors assessed whether use of wireless communication between compatible devices: MiniMed insulin pump and blood glucose meter Contour Link (CL), Bayer results in more frequently bolus calculator using and what is the impact of exerting this tool on metabolic control in type 1 diabetic patients.
Detailed description
In this RCT 156 patients were randomly assigned to one of the 3 arms: group A- subjects using insulin pump bolus calculator wirelessly connected with blood glucose meter, group B- subjects using insulin pump bolus calculator without wireless communication with blood glucose meter or group C- insulin pump, without bolus calculator function. We compared the glycated hemoglobin levels and post- prandial hypoglycaemia after 3 months of observation between the groups. We also assessed secondary endpoints (mentioned above).
Patients were estimated at three time points: at the beginning, after 6 weeks and after 3 months of intervention. Investigators performed computer reports at each visit, with Medtronic CareLink Pro software.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CSII+BC+CL | Experimental | Device: CSII+BC+CLPatients using insulin pump (CSII) bolus calculator (BC) wirelessly connected with blood glucose meter Contour Link (CL) |
| CSII+BC | Experimental | Device: CSII+BCPatients using insulin pump (CSII) bolus calculator (BC) without wireless connection with blood glucose meter (CL) |
| CSII (insulin pump only) | No intervention | –Patients using insulin pump (CSII) without BC and connection with CL |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 7- 18 years old
- type 1 diabetes mellitus for over 1 year
- treatment with insulin pump with bolus calculator function
- HbA1c < 10%
- expressed written informed consent
Key exclusion criteria (1 listed)
- recall the consent
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 |
|---|---|---|
| CSII+BC+CLAlso: Insulin pump, bolus calculator, bolus Wizard, Contour LinkInsulin pump bolus calculator wirelessly communicated with blood glucose meter (Contour Link) | Device | CSII+BC+CL |
| CSII+BCAlso: Insulin pump, bolus calculator, bolus WizardInsulin pump bolus calculator without wireless communication with blood glucose meter (Contour Link) | Device | CSII+BC |
Primary outcome
HbA1c (Glycated hemoglobin)
Time frame: 3 months
7 secondary outcomes
Post- prandial glycaemia
Time frame: 2 hours after the meals
Treatment satisfaction
Time frame: 3 months
Hypoglycaemia episodes and severe hypoglycaemia events
Time frame: 3 months
Frequency of self- blood glucose monitoring
Time frame: 3 months
Hyperglycaemic episodes
Time frame: 3 months
Frequency of meal boluses
Time frame: 3 months
Frequency of bolus calculator using
Time frame: 3 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 3 Sep 2012.
- Derived from this study: PubMed 24115314Ramotowska A, Szypowska A. Bolus calculator and wirelessly communicated blood glucose measurement effectively reduce hypoglycaemia in type 1 diabetic children - randomized controlled trial. Diabetes Metab Res Rev. 2014 Feb;30(2):146-53. doi: 10.1002/dmrr.2477.
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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.
Agnieszka Szypowska, A. Professor study chair
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSII+BC+CL and CSII+BC in people with Type 1 Diabetes Mellitus, run by Medical University of Warsaw at 1 site in Poland.
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 1 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 3 Sep 2012. 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 Poland. 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?
HbA1c (Glycated hemoglobin) (time frame: 3 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 NCT01677546, 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 3 Sep 2012.