Type 1 Diabetes Mellitus With HyperglycemiaVoiceDiabNCT02403427
The Expert System VoiceDiab in Children With Diabetes
A study testing VoiceDiab expert system in people with Type 1 Diabetes Mellitus With Hyperglycemia and Type 1 Diabetes Mellitus With Hypoglycaemia, run by Instytut Diabetologii Sp. z o.o. at 1 site in Poland.
Trial summary
The purpose of this study to conduct the preliminary investigation on the efficacy and safety in terms of postprandial glucose value and the rates of hypoglycaemia when expert VoiceDiab system supports patient's decision on prandial insulin programming in insulin pump therapy. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus With Hyperglycemia, Type 1 Diabetes Mellitus With Hypoglycaemia
- What is being tested?
- VoiceDiab expert system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePoland
- Study dates
- Mar 2015to Dec 2015
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed type 1 diabetes at least 12 month prior screening visit
- Current treatment with basal-bolus regime and insulin pump for at least 12 weeks prior screening visit.
- HbAc < 11%
- Ability and willingness to adhere to the protocol including self-management and dealing with mobile device.
Who cannot join
- Multiply daily injection modality,
- Treatment with regular insulin,
- Use of any anti-diabetic agent,
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Ewa Pankowska
Warsaw, 04-736
Katarzyna Ruszkowska, +48226164474, ruszkowska.kasia@gmail.com
Ewa Pankowska, PhD
About this study
Official title: The Voice Decision Support Expert System in Basal-bolus Insulin Therapy of Diabetes Patients.
The purpose of this study to conduct the preliminary investigation on the efficacy and safety in terms of postprandial glucose value and the rates of hypoglycaemia when expert VoiceDiab system supports patient's decision on prandial insulin programming in insulin pump therapy.
Read the detailed description
In children with type 1 diabetes glucose deterioration occurred every day and night leading into low satisfaction with treatment. Unstable glycemic profile resulting in high glycemic variability depends on the adjustment of insulin dosing to the current needs of the organism. The calculation of prandial insulin dosing is a complex process which involves such factors as preprandial blood glucose level, the amount of food taken, the glycemic index of carbohydrates, the insulin/carbohydrate exchange ratio, the active insulin level following the previous bolus. Currently, in patients treated with continuous subcutaneous insulin infusion (CSII) insulin pumps are equipped with bolus calculators which help to calculate prandial insulin dosing and thus contribute to improve post-prandial blood glucose levels.
The aim of the study was to determine whether the patient's support expert VoiceDiab system have stabilised diurnal glucose profile in children with type 1 diabetes treated with insulin pumps.
- Being tested
- VoiceDiab expert system
- Keywords
- Bolus calculator, Insulin pump, basal-bolus insulin therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VoiceDiab expert systemDevice
Also called patient's decision supporting system
Decision support system VoiceDiab this is computer-based system constructed for mobile phone devices working on the server.
Patients in experimental arm get the mobile phone application for 4 days. Glucose control will be done by two methods SMPG and CGM. Before every study's meal insulin dose with type of bolus will be indicate by VoiceDiab.
| Study group | Role | What they receive |
|---|---|---|
| VoiceDiab expert system | Experimental | the VoiceDiab system using before every main meal; three times per day. Receives: Device: VoiceDiab expert system |
| manual calculation | No intervention | manula insulin calculation before every main meal; three times per day |
What is being measured
The primary outcome is the main question the study is designed to answer.
postprandial glucose
postprandial glucose with respect the hyperglycaemia above 180 mg/dl
Measured: 96 houres
Secondary outcomes (5)
AUC
he Area Under The Curve (AUC) of postprandial glucose level over 240 minutes,
Measured: 240 mintues after each study's meal
PPGE- postprandial glucose excursion
Postprandial Glucose Excursions (PPGE), defined as the change in glucose concentration from before the meal to Peak Postprandial Glucose (PPG),
Measured: 96 houres
hypoglycemia
Hypoglycaemic episodes over time of observation measeured by CGM
Measured: 96 houres
LBGI
Low Blood Glucose Index ( LBGI) - as a one of the glucose variability parameters
Measured: 96 houres
Glucose variability parameters
SD total (SDT)- from all days, SD within days (SDw); SD between time points (SDhh:mm); High Blood Glucose Index (HBGI)
Measured: 96 houres
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes Mellitus With HyperglycemiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instytut Diabetologii Sp. z o.o.
- Sponsor type
- University, hospital or other
- Collaborators
- Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences, National Center for Research and Development, Poland
- Responsible party
- Principal investigator, Ewa Pankowska, Instytut Diabetologii Sp. z o.o.
- Investigators
- Piotr Ladyzynski, PhD, Study director, Institute of Biocybernetics and Biomedicin Engineering in Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403427
- Sponsor's protocol ID
- PBS1/B9/13/2012-I
- Acronym
- VoiceDiab
- Status last verified
- May 2015
- First submitted
- 26 Mar 2015
- Last updated
- 7 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pankowska E, Blazik M, Groele L. Does the fat-protein meal increase postprandial glucose level in type 1 diabetes patients on insulin pump: the conclusion of a randomized study. Diabetes Technol Ther. 2012 Jan;14(1):16-22. doi: 10.1089/dia.2011.0083. Epub 2011 Oct 20.
PubMed 22013887Blazik M, Pankowska E. The education of patients in prandial insulin dosing related to the structure of bolus calculators. Pediatr Endocrinol Diabetes Metab. 2010;16(4):301-5.
PubMed 21447273Kovatchev BP. Diabetes technology: markers, monitoring, assessment, and control of blood glucose fluctuations in diabetes. Scientifica (Cairo). 2012;2012:283821. doi: 10.6064/2012/283821. Epub 2012 Oct 17.
PubMed 24278682McCall AL, Cox DJ, Crean J, Gloster M, Kovatchev BP. A novel analytical method for assessing glucose variability: using CGMS in type 1 diabetes mellitus. Diabetes Technol Ther. 2006 Dec;8(6):644-53. doi: 10.1089/dia.2006.8.644.
PubMed 17109596Blazik M, Pankowska E. The effect of bolus and food calculator Diabetics on glucose variability in children with type 1 diabetes treated with insulin pump: the results of RCT. Pediatr Diabetes. 2012 Nov;13(7):534-9. doi: 10.1111/j.1399-5448.2012.00876.x. Epub 2012 May 14.
PubMed 22577884Pankowska E, Blazik M. Bolus calculator with nutrition database software, a new concept of prandial insulin programming for pump users. J Diabetes Sci Technol. 2010 May 1;4(3):571-6. doi: 10.1177/193229681000400310.
PubMed 20513322Pankowska E, Szypowska A, Lipka M, Szpotanska M, Blazik M, Groele L. Application of novel dual wave meal bolus and its impact on glycated hemoglobin A1c level in children with type 1 diabetes. Pediatr Diabetes. 2009 Aug;10(5):298-303. doi: 10.1111/j.1399-5448.2008.00471.x. Epub 2008 Oct 20.
PubMed 19175902
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Voice Decision Support Expert System in Basal-bolus Insulin Therapy of Diabetes Patients.
- ClinicalTrials.gov ID
- NCT02403427
- Acronym / sponsor ID
- VoiceDiab / PBS1/B9/13/2012-I
- Keywords
- Bolus calculator, Insulin pump, basal-bolus insulin therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Instytut Diabetologii Sp. z o.o.University, hospital or other
- Collaborators
- Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences, National Center for Research and Development, Poland
- Study start
- Mar 2015
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 31 Mar 2015 (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 purpose of this study to conduct the preliminary investigation on the efficacy and safety in terms of postprandial glucose value and the rates of hypoglycaemia when expert VoiceDiab system supports patient's decision on prandial insulin programming in insulin pump therapy.
Detailed description
In children with type 1 diabetes glucose deterioration occurred every day and night leading into low satisfaction with treatment. Unstable glycemic profile resulting in high glycemic variability depends on the adjustment of insulin dosing to the current needs of the organism. The calculation of prandial insulin dosing is a complex process which involves such factors as preprandial blood glucose level, the amount of food taken, the glycemic index of carbohydrates, the insulin/carbohydrate exchange ratio, the active insulin level following the previous bolus. Currently, in patients treated with continuous subcutaneous insulin infusion (CSII) insulin pumps are equipped with bolus calculators which help to calculate prandial insulin dosing and thus contribute to improve post-prandial blood glucose levels.
The aim of the study was to determine whether the patient's support expert VoiceDiab system have stabilised diurnal glucose profile in children with type 1 diabetes treated with insulin pumps.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VoiceDiab expert system | Experimental | Device: VoiceDiab expert systemthe VoiceDiab system using before every main meal; three times per day. |
| manual calculation | No intervention | –manula insulin calculation before every main meal; three times per day |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosed type 1 diabetes at least 12 month prior screening visit
- Current treatment with basal-bolus regime and insulin pump for at least 12 weeks prior screening visit.
- HbAc < 11%
- Ability and willingness to adhere to the protocol including self-management and dealing with mobile device.
Key exclusion criteria (3 listed)
- Multiply daily injection modality,
- Treatment with regular insulin,
- Use of any anti-diabetic agent,
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 |
|---|---|---|
| VoiceDiab expert systemAlso: patient's decision supporting systemDecision support system VoiceDiab this is computer-based system constructed for mobile phone devices working on the server. Patients in experimental arm get the mobile phone application for 4 days. Glucose control will be done by two methods SMPG and CGM. Before every study's meal insulin dose with type of bolus will be indicate by VoiceDiab. | Device | VoiceDiab expert system |
Primary outcome
postprandial glucose
Time frame: 96 houres
postprandial glucose with respect the hyperglycaemia above 180 mg/dl
5 secondary outcomes
AUC
Time frame: 240 mintues after each study's meal
PPGE- postprandial glucose excursion
Time frame: 96 houres
hypoglycemia
Time frame: 96 houres
LBGI
Time frame: 96 houres
Glucose variability parameters
Time frame: 96 houres
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2015.
- Background: PubMed 22013887Pankowska E, Blazik M, Groele L. Does the fat-protein meal increase postprandial glucose level in type 1 diabetes patients on insulin pump: the conclusion of a randomized study. Diabetes Technol Ther. 2012 Jan;14(1):16-22. doi: 10.1089/dia.2011.0083. Epub 2011 Oct 20.
- Background: PubMed 21447273Blazik M, Pankowska E. The education of patients in prandial insulin dosing related to the structure of bolus calculators. Pediatr Endocrinol Diabetes Metab. 2010;16(4):301-5.
- Background: PubMed 24278682Kovatchev BP. Diabetes technology: markers, monitoring, assessment, and control of blood glucose fluctuations in diabetes. Scientifica (Cairo). 2012;2012:283821. doi: 10.6064/2012/283821. Epub 2012 Oct 17.
- Background: PubMed 17109596McCall AL, Cox DJ, Crean J, Gloster M, Kovatchev BP. A novel analytical method for assessing glucose variability: using CGMS in type 1 diabetes mellitus. Diabetes Technol Ther. 2006 Dec;8(6):644-53. doi: 10.1089/dia.2006.8.644.
- Results publication: PubMed 22577884Blazik M, Pankowska E. The effect of bolus and food calculator Diabetics on glucose variability in children with type 1 diabetes treated with insulin pump: the results of RCT. Pediatr Diabetes. 2012 Nov;13(7):534-9. doi: 10.1111/j.1399-5448.2012.00876.x. Epub 2012 May 14.
- Results publication: PubMed 20513322Pankowska E, Blazik M. Bolus calculator with nutrition database software, a new concept of prandial insulin programming for pump users. J Diabetes Sci Technol. 2010 May 1;4(3):571-6. doi: 10.1177/193229681000400310.
- Results publication: PubMed 19175902Pankowska E, Szypowska A, Lipka M, Szpotanska M, Blazik M, Groele L. Application of novel dual wave meal bolus and its impact on glycated hemoglobin A1c level in children with type 1 diabetes. Pediatr Diabetes. 2009 Aug;10(5):298-303. doi: 10.1111/j.1399-5448.2008.00471.x. Epub 2008 Oct 20.
- pubmedLink provided by the sponsor.
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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.
Piotr Ladyzynski, PhD study director
Institute of Biocybernetics and Biomedicin Engineering in Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VoiceDiab expert system in people with Type 1 Diabetes Mellitus With Hyperglycemia and Type 1 Diabetes Mellitus With Hypoglycaemia, run by Instytut Diabetologii Sp. z o.o. 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 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: status not confirmed, as of the sponsor's last update on 7 May 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ewa Pankowska, PhD (+48226164474, pankowskae@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postprandial glucose (time frame: 96 houres). 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 NCT02403427, which also lists 7 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 7 May 2015.