New Strategies for Postprandial Glycemic Control Using Insulin Pump Therapy

This study has been completed.
Sponsor:
Collaborators:
European Union
Ministerio de Ciencia e Innovación, Spain
Information provided by (Responsible Party):
Fundación para la Investigación del Hospital Clínico de Valencia
ClinicalTrials.gov Identifier:
NCT01550809
First received: February 28, 2012
Last updated: August 20, 2012
Last verified: August 2012
Results First Received: June 5, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Type 1 Diabetes
Interventions: Other: iBolus
Other: tBolus (traditional bolus)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Twelve patients were recruited in this two-way, crossover study. One factor was the type of the insulin bolus administered (iBolus or tBolus). The other factor was the amount of carbohydrates (Low- or High-CHO meal) ingested. Recruitment started in February 2010 and was terminated by the end of June 2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Subjects received the i- or the tBolus on the first meal study (either Low or High CHO), according to one of the following sequences:

  1. iBolus first+low CHO first
  2. iBolus first+high CHO first
  3. tBolus first+low CHO first
  4. tBolus first+high CHO first

Each one of the four meal tests was performed 1-2 weeks apart from the others


Reporting Groups
  Description
tBolus (Traditional Bolus) Traditional mealtime bolus based on the individual insulin-to-CHO ratio
iBolus (CGM-based Insulin Administration) This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.

Participant Flow:   Overall Study
    tBolus (Traditional Bolus)     iBolus (CGM-based Insulin Administration)  
STARTED     6 [1]   6 [2]
COMPLETED     6     6  
NOT COMPLETED     0     0  
[1] Six patients started with the tBolus, the others with the iBolus, according to a crossover design.
[2] Six patients started with the iBolus, the others with the tBolus, according to a crossover design.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
tBolus (Traditional Bolus) Traditional mealtime bolus based on the individual insulin-to-CHO ratio
iBolus (CGM-based Insulin Administration) This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
Total Total of all reporting groups

Baseline Measures
    tBolus (Traditional Bolus)     iBolus (CGM-based Insulin Administration)     Total  
Number of Participants  
[units: participants]
  6     6     12  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     6     6     12  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  43.6  ± 6.8     40.3  ± 7.9     41.8  ± 7.3  
Gender  
[units: participants]
     
Female     4     5     9  
Male     2     1     3  
Region of Enrollment  
[units: participants]
     
Spain     6     6     12  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Area Under the Curve (AUC) of Plasma Glucose (PG) Concentrations During the 5-hour Postprandial Period (AUC-PG0-5 h).   [ Time Frame: The whole experiment, i.e. 5 hours ]

2.  Primary:   The Area Under the Curve (AUC) of the Glucose Infusion Rate (GIR) During the 5-hour Postprandial Period (AUC-GIR0-5h).   [ Time Frame: The whole experiment, i.e. 5 hours. ]

3.  Secondary:   The Area Under the Curve (AUC) of Plasma Glucose (PG) Above the Threshold of 140 mg/dl (AUC-PG>140).   [ Time Frame: The whole experiment, i.e. the 5-hour postprandial period ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Francisco Javier Ampudia Blasco
Organization: Departamento de Endocrinología y Nutrición, Hospital Clínico Universitario de Valencia, Universitat de València, Valencia, Spain
phone: +34 96 3862665
e-mail: Francisco.J.Ampudia@uv.es


No publications provided


Responsible Party: Fundación para la Investigación del Hospital Clínico de Valencia
ClinicalTrials.gov Identifier: NCT01550809     History of Changes
Other Study ID Numbers: FP7-PEOPLE-2009-IEF #252085, DPI2010-20764-C02-01
Study First Received: February 28, 2012
Results First Received: June 5, 2012
Last Updated: August 20, 2012
Health Authority: Spain: Ethics Committee