Effect of the Fat Content of the Bedtime Snack on Overnight Hypoglycemia
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date ICMJE | June 28, 2007 | ||||
Last Updated Date | January 10, 2008 | ||||
Start Date ICMJE | March 2006 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE | |||||
Original Primary Outcome Measures ICMJE | |||||
Change History | Complete list of historical versions of study NCT00493935 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Effect of the Fat Content of the Bedtime Snack on Overnight Hypoglycemia | ||||
Official Title ICMJE | Nocturnal Hypoglycemia Prevention Study: Effect of the Fat Content of the Bedtime Snack on Overnight Hypoglycemia | ||||
Brief Summary | Low blood sugar at night (called nocturnal hypoglycemia), can often happen without symptoms and can last for a long time. Doctors often suggest that patients take a bedtime snack to try to prevent low blood sugar at night from happening, but it is not known what type of snack is best to take. We are conducting a study to evaluate how two different types of snacks affect how often the blood sugar is too low overnight. One snack will be a primarily carbohydrate snack and the other will be a carbohydrate snack with fat. The snacks will be provided by the study. As part of the study, a continuous glucose sensor (the Freestyle Navigator) will be worn overnight. The Freestyle Navigator was developed by Abbott Diabetes Care. This sensor uses a glucose oxidase based electrochemical sensor, and is designed to measure blood glucose levels in a range of 20-500 mg/dl. The sensor is inserted subcutaneously and measures interstitial glucose. In human studies the interstitial glucose levels generally lag behind the blood glucose by 3 to13 minutes.(27, 28) The Freestyle Navigator, provides a glucose reading every 60 seconds (or 1440 readings a day). Each sensor is designed to provide readings for up to 120 hours. It has alarms for hypoglycemia and hyperglycemia and for projected high and low glucose values. The alarm set points can be adjusted by the user. The Navigator also has a trend arrow indicating the glucose rate of change (>-2 mg/dL/min, -2 to -1 mg/dL/min, -1 to 1 mg/dL/min, 1 to 2 mg/dl/min, and >2 mg/dl/min). Subjects can enter events, such as when they took insulin, ate, or exercised. The sensor requires calibration values to be entered 3 times during the first day of wear, and then 2 additional times during the 5-day wear period. The values are entered directly into the Navigator which has a Freestyle home glucose meter built into the unit. The Navigator has not yet been approved by the FDA. The Navigator currently under review by the FDA will limit sensor wear to 3 days. This study is being done to see if there is a difference in low blood sugar overnight after having a bedtime snack made up of carbohydrate compared to a carbohydrate snack with more fat. |
||||
Detailed Description | There will be about 100 children in the study. The children will take part at five centers in the United States. When a child enters the study, the following will be done:
If the child was able to wear the Navigator, complete the blood sugar testing, and complete the questionnaire each night on the DirecNet website, the child will continue in the study.
Follow-up Visit After using the Navigator at home for 12 nights, the child will return to the clinic for the follow-up visit.
|
||||
Study Type ICMJE | Observational | ||||
Study Design ICMJE | Time Perspective: Prospective | ||||
Biospecimen | |||||
Sampling Method | |||||
Study Population | |||||
Condition ICMJE | Diabetes Mellitus, Type I | ||||
Intervention ICMJE | |||||
Study Group/Cohort (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Estimated Enrollment ICMJE | 100 | ||||
Completion Date | August 2007 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Gender | Both | ||||
Ages | 8 Years to 17 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00493935 | ||||
Other Study ID Numbers ICMJE | DirecNet 008, HD041890, HD041906, HD041918, HD041915, HD041908, HD041919 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | |||||
Study Sponsor ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
Collaborators ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||
Investigators ICMJE |
|
||||
Information Provided By | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
Verification Date | August 2005 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |