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NCT00493935 · ClinicalTrials.gov registry record
Effect of the Fat Content of the Bedtime Snack on Overnight Hypoglycemia
A clinical trial, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- 100
- Enrollment target
NCT00493935 is a clinical trial that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 100 participants.
The verdict
NCT00493935 has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- 100 participants
- Enrollment target
Study 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2006-03 |
| Est. Completion | 2007-08 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00493935
The ClinicalTrials.gov registry entry for NCT00493935 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jaeb Center for Health Research, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00493935 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00493935 about?
NCT00493935 is a clinical study titled "Effect of the Fat Content of the Bedtime Snack on Overnight Hypoglycemia". 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...
What is the current status of trial NCT00493935?
This trial is currently completed. The enrollment target is 100 participants. The study started on 2006-03. Estimated completion is 2007-08.
Who is sponsoring clinical trial NCT00493935?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
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