NCT03179280

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 7, 2017

Completed
Last Updated

June 7, 2017

Status Verified

June 1, 2017

Enrollment Period

2 months

First QC Date

May 4, 2017

Last Update Submit

June 6, 2017

Conditions

Type1 Diabetes

Keywords

Type 1 diabetesDual-wave bolusPostprandial euglycaemia

Outcome Measures

Primary Outcomes (1)

  • 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

    3 days

Study Arms (2)

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.

Drug: insulin

Healthy adolescents

NO INTERVENTION

3 standard meals with varying composition were consumed

Interventions

insulinDRUG

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.

Also known as: NovoRapid
Adolescents with T1D on CSII

Eligibility Criteria

Age11 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • Subjects with eating disorders, food allergy, celiac disease and known diabetic complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit of Pediatric Endocrinology, Diabetes and Metabolism-4th Department of Pediatrics, Medical School of Aristotle University of Thessaloniki

Thessaloniki, 56403, Greece

Location

Related Publications (3)

  • 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.

    PMID: 20144405RESULT

  • Chase 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.

    PMID: 11943004RESULT

  • Lee 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.

    PMID: 15575341RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

InsulinInsulin Aspart

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Short-Acting

Study Officials

  • Assimina Galli-Tsinopoulou, Ass Prof

    Unit of Pediatric Endocrinology, Diabetes and Metabolism-4th Department of Pediatrics, Medical School of Aristotle University of Thessaloniki

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, 4th Department of Pediatrics, Medical School of Aristotle University of Thessaloniki

Study Record Dates

First Submitted

May 4, 2017

First Posted

June 7, 2017

Study Start

March 1, 2011

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

June 7, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)