Effect of the Fat Content of the Bedtime Snack on Overnight Hypoglycemia

NCT00493935 | Completed

• 7 other identifiers: DirecNet 008HD041890HD041906HD041918HD041915HD041908HD041919
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 6

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.

Conditions

Diabetes Mellitus, Type I

Keywords

bedtime snack; hypoglycemia; Diabetes Mellitus, Type I; glucose monitoring

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year (The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.)
• Age 8.0 years to less than 18.0 years
• HbA1c \<10.0% (The DCA2000 will be used to assess eligibility.)
• Stable insulin regimen for at least 1 month and not anticipating a change prior to the subject's completion of the study (Stable is defined as no change in the overall insulin program, i.e., no change from SC injections to pump or Lantus therapy, or Lantus therapy to pump.)
• Insulin regimen involves either use of an insulin pump or Lantus (with short-acting insulin)
• NPH or Lente, if part of the insulin regimen, is given only in the morning before breakfast
• Subject is willing to have a bedtime snack each night and routinely has a snack at least 4 out of 7 nights as part of his/her normal diabetes management
• Subject has a home computer with internet access
• For females, subject not intending to become pregnant during the next month
• No expectation that subject will be moving out of the area of the clinical center during the next month

You may not qualify if:

• The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
• Known Celiac disease or other medical disorder (including lactose intolerance or food allergies such as peanuts) which would prevent the subject from consuming the bedtime snack
• The presence of any of the following diseases:
• Asthma if treated with systemic or inhaled corticosteroids in the last 6 months
• Cystic fibrosis
• Other major illness that in the judgment of the investigator might interfere with the completion of the protocol (Adequately treated thyroid disease does not exclude subjects from enrollment)
• Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (6)

Division of Pediatric Endocrinology and Diabetes, Stanford University

Stanford, California, 94305-5208, United States

Location

Barbara Davis Center for Childhood Diabetes, University of Colorado

Aurora, Colorado, 80010, United States

Location

Department of Pediatrics, Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Jaeb Center for Health Research

Tampa, Florida, 33647, United States

Location

Department of Pediatrics, University of Iowa Carver College of Medicine

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• William V Tamborlane, M.D.

  Department of Pediatrics, Yale University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2007
• First Posted: June 29, 2007
• Study Start: March 1, 2006
• Study Completion: August 1, 2007
• Last Updated: September 5, 2016

Record last verified: 2016-09

Locations

US (6)