Type1 DiabetesNCT03179280
Effect of Dual-wave Insulin Bolus on Postprandial Glycaemia
A study testing insulin in people with Type1 Diabetes, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
A study was conducted in adolescents with type 1 diabetes (T1D) examining the effect of different bolus types on 6-h postprandial glucose levels after the consumption of 3 standard meals with varying composition. Participants were asked to consume 10 different combinations of meal and bolus type. Read more about this study
- Who is it for?
- Ages 11 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Type1 Diabetes
- What is being tested?
- insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGreece
- Study dates
- Mar 2011to May 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 11 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- duration of T1D >3 years, CSII therapy for at least 1 year, good to moderate glycaemic control, as evidenced by HbA1c levels <8.5% (69 mmol/mol).
Who cannot join
- Subjects with eating disorders, food allergy, celiac disease and known diabetic complications
Trial locations and contacts
1 site in 1 country.
Greece1 site
Unit of Pediatric Endocrinology, Diabetes and Metabolism-4th Department of Pediatrics, Medical School of Aristotle University of Thessaloniki
Thessaloniki, 56403
About this study
Official title: Effect of Dual-wave Insulin Bolus on Postprandial Glycaemia According to the Composition of the Meal in Adolescents With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion
A study was conducted in adolescents with type 1 diabetes (T1D) examining the effect of different bolus types on 6-h postprandial glucose levels after the consumption of 3 standard meals with varying composition. Participants were asked to consume 10 different combinations of meal and bolus type.
Read the detailed description
The nutritional recommendations of children and adolescents with T1D should be similar to those of healthy people in order to achieve the desirable growth. Not only the carbohydrates' intake is underlined according to special guidelines by Canadian diabetes association, American diabetes association and International Society for Paediatric and Adolescent Diabetes but also proteins and fats are suggested to be taken into consideration in the management of T1D. In order to reach the desirable euglycemic control, children and adolescents can use multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). By using the CSII the insulin can be administrated in three different patterns; as a normal bolus, as a dual wave bolus and as a square wave bolus. Dual wave insulin bolus (D/WB) is suggested as the most suitable option based on the effects that is having after meals with different content of carbohydrates, fats and proteins. The aim of this study was to evaluate the impact of different types of D/WB on PPG after 3 given meals, in adolescents with T1D on CSII. In order to achieve that, 3 different meals were designed and combined with alternative types of boluses, D/WB and square wave insulin bolus (S/WB).
- Conditions
- Type1 Diabetes
- Being tested
- insulin
- Keywords
- Type 1 diabetes, Dual-wave bolus, Postprandial euglycaemia
- 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.
insulinDrug
Also called NovoRapid
All participants used the rapid-acting insulin analogue aspart (NovoRapid®, Novonordisk A/S, Bagsvaerd, Denmark) and total insulin dose administered to each one for each test meal was known in advance, according to the insulin to carbohydrate ratio that had been calculated during the 2-week pre-study period.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents with T1D on CSII | Active comparator | 3 standard meals with varying composition were consumed and combined with alternative types of D/WB and S/WB All participants used the rapid-acting insulin analogue aspart (NovoRapid®, Novonordisk A/S, Bagsvaerd, Denmark) and total insulin dose administered to each one for each test meal was known in advance, according to the insulin to carbohydrate ratio that had been calculated during the 2-week pre-study period. Receives: Drug: insulin |
| Healthy adolescents | No intervention | 3 standard meals with varying composition were consumed |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-prandial euglycaemia (PPG)
the impact of different types of D/WB on PPG after three given meals, in adolescents with T1D on CSII. In order to achieve that, three different meals were designed and combined with alternative types of boluses, D/WB and S/WB
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study startMar 2011
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type1 DiabetesStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assimina Galli-Tsinopoulou, Aristotle University Of Thessaloniki
- Investigators
- Assimina Galli-Tsinopoulou, Ass Prof, Study chair, Unit of Pediatric Endocrinology, Diabetes and Metabolism-4th Department of Pediatrics, Medical School of Aristotle University of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179280
- Sponsor's protocol ID
- Dual-wave insulin
- Status last verified
- Jun 2017
- First submitted
- 4 May 2017
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heinemann L. Insulin pump therapy: what is the evidence for using different types of boluses for coverage of prandial insulin requirements? J Diabetes Sci Technol. 2009 Nov 1;3(6):1490-500. doi: 10.1177/193229680900300631.
PubMed 20144405Chase HP, Saib SZ, MacKenzie T, Hansen MM, Garg SK. Post-prandial glucose excursions following four methods of bolus insulin administration in subjects with type 1 diabetes. Diabet Med. 2002 Apr;19(4):317-21. doi: 10.1046/j.1464-5491.2002.00685.x.
PubMed 11943004Lee SW, Cao M, Sajid S, Hayes M, Choi L, Rother C, de Leon R. The dual-wave bolus feature in continuous subcutaneous insulin infusion pumps controls prolonged post-prandial hyperglycaemia better than standard bolus in Type 1 diabetes. Diabetes Nutr Metab. 2004 Aug;17(4):211-6.
PubMed 15575341
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dual-wave Insulin Bolus on Postprandial Glycaemia According to the Composition of the Meal in Adolescents With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion
- ClinicalTrials.gov ID
- NCT03179280
- Acronym / sponsor ID
- Dual-wave insulin
- Conditions
- Type1 Diabetes
- Keywords
- Type 1 diabetes, Dual-wave bolus, Postprandial euglycaemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Mar 2011 (actual)
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 7 Jun 2017 (actual)
- 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.
A study was conducted in adolescents with type 1 diabetes (T1D) examining the effect of different bolus types on 6-h postprandial glucose levels after the consumption of 3 standard meals with varying composition. Participants were asked to consume 10 different combinations of meal and bolus type.
Detailed description
The nutritional recommendations of children and adolescents with T1D should be similar to those of healthy people in order to achieve the desirable growth. Not only the carbohydrates' intake is underlined according to special guidelines by Canadian diabetes association, American diabetes association and International Society for Paediatric and Adolescent Diabetes but also proteins and fats are suggested to be taken into consideration in the management of T1D. In order to reach the desirable euglycemic control, children and adolescents can use multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). By using the CSII the insulin can be administrated in three different patterns; as a normal bolus, as a dual wave bolus and as a square wave bolus. Dual wave insulin bolus (D/WB) is suggested as the most suitable option based on the effects that is having after meals with different content of carbohydrates, fats and proteins. The aim of this study was to evaluate the impact of different types of D/WB on PPG after 3 given meals, in adolescents with T1D on CSII. In order to achieve that, 3 different meals were designed and combined with alternative types of boluses, D/WB and square wave insulin bolus (S/WB).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescents with T1D on CSII | Active comparator | Drug: insulin3 standard meals with varying composition were consumed and combined with alternative types of D/WB and S/WB All participants used the rapid-acting insulin analogue aspart (NovoRapid®, Novonordisk A/S, Bagsvaerd, Denmark) and total insulin dose administered to each one for each test meal was known in advance, according to the insulin to carbohydrate ratio that had been calculated during the 2-week pre-study period. |
| Healthy adolescents | No intervention | –3 standard meals with varying composition were consumed |
Who may qualify
- Ages
- 11 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- duration of T1D >3 years, CSII therapy for at least 1 year, good to moderate glycaemic control, as evidenced by HbA1c levels <8.5% (69 mmol/mol).
Key exclusion criteria (1 listed)
- Subjects with eating disorders, food allergy, celiac disease and known diabetic complications
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 |
|---|---|---|
| insulinAlso: NovoRapidAll participants used the rapid-acting insulin analogue aspart (NovoRapid®, Novonordisk A/S, Bagsvaerd, Denmark) and total insulin dose administered to each one for each test meal was known in advance, according to the insulin to carbohydrate ratio that had been calculated during the 2-week pre-study period. | Drug | Adolescents with T1D on CSII |
Primary outcome
post-prandial euglycaemia (PPG)
Time frame: 3 days
the impact of different types of D/WB on PPG after three given meals, in adolescents with T1D on CSII. In order to achieve that, three different meals were designed and combined with alternative types of boluses, D/WB and S/WB
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 7 Jun 2017.
- Results publication: PubMed 20144405Heinemann L. Insulin pump therapy: what is the evidence for using different types of boluses for coverage of prandial insulin requirements? J Diabetes Sci Technol. 2009 Nov 1;3(6):1490-500. doi: 10.1177/193229680900300631.
- Results publication: PubMed 11943004Chase HP, Saib SZ, MacKenzie T, Hansen MM, Garg SK. Post-prandial glucose excursions following four methods of bolus insulin administration in subjects with type 1 diabetes. Diabet Med. 2002 Apr;19(4):317-21. doi: 10.1046/j.1464-5491.2002.00685.x.
- Results publication: PubMed 15575341Lee SW, Cao M, Sajid S, Hayes M, Choi L, Rother C, de Leon R. The dual-wave bolus feature in continuous subcutaneous insulin infusion pumps controls prolonged post-prandial hyperglycaemia better than standard bolus in Type 1 diabetes. Diabetes Nutr Metab. 2004 Aug;17(4):211-6.
- Individual participant dataSharing planned: No
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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.
Assimina Galli-Tsinopoulou, Ass Prof study chair
Unit of Pediatric Endocrinology, Diabetes and Metabolism-4th Department of Pediatrics, Medical School of Aristotle University of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing insulin in people with Type1 Diabetes, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 1 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 7 Jun 2017. 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 Greece. 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?
post-prandial euglycaemia (PPG) (time frame: 3 days). 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 NCT03179280, which also lists 3 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 Jun 2017.