Type 1 Diabetes Mellitus
Conditions
Keywords
glycemic index, Diabetes Mellitus, continuous glucose monitoring
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDexcom Seven® Plus Continuous Glucose Monitoring sensor
A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject.
Sponsors
Juvenile Diabetes Research Foundation
Legacy Health System
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* clinical diagnosis of type 1 diabetes mellitus * patients on insulin pump therapy
Exclusion criteria
Any patient who was * pregnancy * cardiovascular, cerebrovascular, kidney, or liver disease * uncontrolled chronic medical conditions * oral or parenteral corticosteroid use * immunosuppressant use * visual or physical impairments that impede the use of a continuous glucose monitoring device * insulin or glucagon allergy * hypoglycemia unawareness * requirement of greater than 200 units of insulin per day * gastroparesis * any prior gastric surgery * an allergy to any food items served.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Area Under the Curve for Rise in Breakfast Post-prandial. | 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. |
Countries
United States
Participant flow
Recruitment details
Seven subjects with Type 1 diabetes mellitus on subcutaneous insulin pump therapy were recruited from clinics in Portland, Oregon, USA.
Participants by arm
| Arm | Count |
|---|---|
| All Study 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. | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 45 years STANDARD_DEVIATION 4.5 |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Glycemic Index Effect on Post-prandial Peak | Mean Area Under the Curve for Rise in Breakfast Post-prandial. | 61 min x (mmol/l) | Standard Deviation 135 |
| High Glycemic Index Effect on Post-prandial Peak | Mean Area Under the Curve for Rise in Breakfast Post-prandial. | 583 min x (mmol/l) | Standard Deviation 113 |