An interventional study of Bolus timing and dosing in Type 1 Diabetes, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 7 Years to 21 Years. Per ClinicalTrials.gov, last updated 2012-11-22.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
The investigators are hoping to figure out how youth with type 1 diabetes can best control their blood glucose levels after meals, by determining whether accurate carbohydrate dosing or the timing of the bolus is more important. There is evidence to suggest that each strategy is important for blood glucose control. Unfortunately, for some people, prebolusing is difficult, because they may not know how much they are going to eat. To give an exact dose of insulin 20 minutes before a meal can be difficult. In this study, the investigators would like to show that taking even just part of the insulin bolus 20 minutes before the meal is preferable to waiting until mealtime and taking the entire bolus. To do this, the investigators will have 24 patients in the study, who will each spend 4 mornings at The investigators clinic. The order of the visits will be selected randomly. The visits will include: taking full bolus at mealtime, taking full bolus 20 minute before mealtime, taking ½ bolus at mealtime, and taking ½ bolus 20 minutes before mealtime. At each visit, the person will eat the same meal, but the timing and amount of the bolus will be different. The investigators will measure the blood glucose levels with a blood glucose meter, and also with a laboratory test called YSI. The investigators will also be measuring the glucose levels under the person's skin with a continuous glucose monitor. The investigators will compare the area under the curve for the different visits, as well as the glucose levels at different points after the meal.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 21 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
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Exclusion Criteria:
Will administer full insulin bolus 20 minutes prior to meal
Other: Bolus timing and dosing
Will administer full meal bolus at the start of the meal
Other: Bolus timing and dosing
Will only give half the insulin dose 20 minutes before meal
Other: Bolus timing and dosing
Will give half the amount of insulin at the time of the meal
Other: Bolus timing and dosing
We will be altering the timing and dosages of the prescribed meal bolus.
Blood glucose area under the curve
Time frame: 4 hours post-meal
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver