Trial Outcomes & Findings for Continuous Glucose Monitoring to Measure Effect of Glycemic Index (NCT NCT01145547)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

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

Results posted on

2015-10-23

Participant Flow

Seven subjects with Type 1 diabetes mellitus on subcutaneous insulin pump therapy were recruited from clinics in Portland, Oregon, USA.

Participant milestones

Participant milestones
Measure	Low Glycemic Index, High Glycemic Index 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.	High Glycemic Index, Low Glycemic Index 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.
Overall Study STARTED	4	3
Overall Study COMPLETED	4	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Continuous Glucose Monitoring to Measure Effect of Glycemic Index

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=7 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	45 years STANDARD_DEVIATION 4.5 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Low Glycemic Index Effect on Post-prandial Peak n=7 Participants 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.	High Glycemic Index Effect on Post-prandial Peak n=7 Participants 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.
Mean Area Under the Curve for Rise in Breakfast Post-prandial.	61 min x (mmol/l) Standard Deviation 135	583 min x (mmol/l) Standard Deviation 113

Adverse Events

Low Glycemic Index Effect on Post-prandial Peak

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

High Glycemic Index Effect on Post-prandial Peak

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

W. Kenneth Ward

Legacy Health System

Phone: 503-413-5171

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place