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Trial record 41 of 750 for:    Area Under Curve AND meal

Continuous Glucose Monitoring to Measure Effect of Glycemic Index

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ClinicalTrials.gov Identifier: NCT01145547
Recruitment Status : Completed
First Posted : June 16, 2010
Results First Posted : October 5, 2015
Last Update Posted : October 23, 2015
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
W. Kenneth Ward, Legacy Health System

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Supportive Care
Condition Type 1 Diabetes Mellitus
Intervention Device: Dexcom Seven® Plus Continuous Glucose Monitoring sensor
Enrollment 7
Recruitment Details Seven subjects with Type 1 diabetes mellitus on subcutaneous insulin pump therapy were recruited from clinics in Portland, Oregon, USA.
Pre-assignment Details  
Arm/Group Title Low Glycemic Index, High Glycemic Index High Glycemic Index, Low Glycemic Index
Hide Arm/Group Description

Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In this arm, subjects completed the first study consuming meals with low glycemic index followed by a second study consuming meals with a high glycemic index

Dexcom Seven® Plus Continuous Glucose Monitoring sensor: A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject.

Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In this arm, subjects completed the first study consuming meals with high glycemic index followed by a second study consuming meals with a low glycemic index

Dexcom Seven® Plus Continuous Glucose Monitoring sensor: A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject.

Period Title: Overall Study
Started 4 3
Completed 4 3
Not Completed 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description

Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low Glycemic Index and in one experiment, both meals had a high Glycemic Index.

Dexcom Seven® Plus Continuous Glucose Monitoring sensor: A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject.

Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
45  (4.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
4
  57.1%
Male
3
  42.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants
7
1.Primary Outcome
Title Mean Area Under the Curve for Rise in Breakfast Post-prandial.
Hide Description Arterialized blood glucose was monitored at 15 minute intervals and sensed glucose was recorded at five minute intervals. Mean area under the curve was calculated over the 3 hour period after breakfast for both the high and low glycemic breakfast meals.
Time Frame Mean area under the curve was calculated at 0, 15min, 30 min, 45 min, 60min, 75 min, 90 min, 105 min, 120min, 135min, 150min, 165min and 180 min after breakfast
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Glycemic Index Effect on Post-prandial Peak High Glycemic Index Effect on Post-prandial Peak
Hide Arm/Group Description:
Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low Glycemic Index.
Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a high Glycemic Index.
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: min x (mmol/l)
61  (135) 583  (113)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low Glycemic Index Effect on Post-prandial Peak High Glycemic Index Effect on Post-prandial Peak
Hide Arm/Group Description Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low Glycemic Index. Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a high Glycemic Index.
All-Cause Mortality
Low Glycemic Index Effect on Post-prandial Peak High Glycemic Index Effect on Post-prandial Peak
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Low Glycemic Index Effect on Post-prandial Peak High Glycemic Index Effect on Post-prandial Peak
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Low Glycemic Index Effect on Post-prandial Peak High Glycemic Index Effect on Post-prandial Peak
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: W. Kenneth Ward
Organization: Legacy Health System
Phone: 503-413-5171
EMail: kenward503@msn.com
Layout table for additonal information
Responsible Party: W. Kenneth Ward, Legacy Health System
ClinicalTrials.gov Identifier: NCT01145547     History of Changes
Other Study ID Numbers: kw01
First Submitted: June 15, 2010
First Posted: June 16, 2010
Results First Submitted: September 1, 2015
Results First Posted: October 5, 2015
Last Update Posted: October 23, 2015