An interventional study of Dexcom Seven® Plus Continuous Glucose Monitoring sensor in Type 1 Diabetes Mellitus, sponsored by Legacy Health System. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2015-10-23.
Sponsored by Legacy Health System · Not applicable, Interventional, and Supportive care
Background: Post-prandial hyperglycemia is common in people with type 1 diabetes.
Objective: The aim was to determine the impact of low vs high glycemic index (GI) on post-prandial glycemia for breakfast vs lunch and to quantify these effects with continuous glucose monitoring.
Design: 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 GI; in the other, high GI. Meals were given 195 minutes apart and were matched for carbohydrate, protein, and fat content. Each subject received his usual pre-prandial insulin dosage, followed by a continuous subcutaneous basal insulin infusion for the remainder of the experiment. Arterialized venous glucose was analyzed every 15 minutes and sensor glucose was recorded every 5 minutes.
A total of 14 diet studies (each with two meals) were completed in three men and four women. All subjects completed two diet studies in which two meals were served 195 minutes apart. On one study day, two high GI (> 75) meals were given, and on the other study day, two low GI (\< 30) meals were given. The low GI and high GI meals were matched for amount of carbohydrates, protein, and fat based on a weight-maintaining diet for each subject. The order of the study treatment (high or low GI) was randomized. Subjects were not informed as the GI of any meal.
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This study's enrollment of 7 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Inclusion Criteria:
Exclusion Criteria:Any patient who was
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.
Device: Dexcom Seven® Plus Continuous Glucose Monitoring sensor
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.
Device: Dexcom Seven® Plus Continuous Glucose Monitoring sensor
A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject.
Mean Area Under the Curve for Rise in Breakfast Post-prandial.
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
Seven subjects with Type 1 diabetes mellitus on subcutaneous insulin pump therapy were recruited from clinics in Portland, Oregon, USA.
| Milestone | Low Glycemic Index, High Glycemic Index | High Glycemic Index, Low Glycemic Index |
|---|---|---|
| Started | 4 | 3 |
| Completed | 4 | 3 |
| Not completed | 0 | 0 |
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.
| min x (mmol/l) | Low Glycemic Index Effect on Post-prandial Peak | High Glycemic Index Effect on Post-prandial Peak |
|---|---|---|
| Mean Area Under the Curve for Rise in Breakfast Post-prandial. | 61 ± 135 | 583 ± 113 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Low Glycemic Index Effect on Post-prandial Peak | — | 0/7 (0%) | 0/7 (0%) |
| High Glycemic Index Effect on Post-prandial Peak | — | 0/7 (0%) | 0/7 (0%) |
| Age, Categorical(Participants) | All Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 7 |
| >=65 years | 0 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 45 ± 4.5 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 4 |
| Male | 3 |
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United States | 7 |
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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