An interventional study of Late night snack and No late night snack in Type 1 Diabetes and Hypoglycemia, sponsored by Diabeteszentrum Bad Lauterberg im Harz. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-08-18.
Sponsored by Diabeteszentrum Bad Lauterberg im Harz · Not applicable, Interventional, and Prevention
Twenty patient with Type 1 diabetes, using insulin glargine as basal insulin, participated in a prospective, controlled crossover trial comparing blood glucose profiles over two 24 h periods with and without a late night snack (a slice of rye bread, 20 g carbohydrates, at 10 p.m.), in randomized order. The main endpoint was the number of hypoglycemic episodes with a confirmed laboratory blood glucose ≤ 50 mg/dl between 10 p.m. and 8 p.m. the following day. Secondary endpoint was the blood glucose profile during this period.
The order of studies (with and without a late night snack) was determined by randomization. Study-related procedures started at 6 p.m. (standard blood glucose profiles with determinations at 6, 8, and 10 p.m, at midnight, at 2, 4, 6:45, 8:45 a.m., and at noon and 2, 6, and 8 p.m. of the following day). At 10 p.m. a late night snack (one slice of whole meal rye bread containing approximately 20 g of carbohydrate) was eaten or no nutrients were consumed, as determined by the randomization protocol. After one day without study-related activities, the study was repeated with the complementary protocol (crossover design). Patients were instructed to use fast-acting insulin to correct hyperglycemia three times per day (before major meals) or to take in additional carbohydrate when symptomatic or chemical hypoglycemia was noted. They were asked not to perform strenuous exercise beyond their normal daily activities.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Diabeteszentrum Bad Lauterberg im Harz is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
At 10 p.m. a late night snack (one slice of whole meal rye bread containing approximately 20 g of carbohydrate) was eaten from Type 1 diabetic patients on an intensified conventional treatment regimen.
Dietary Supplement: Late night snack
Not nutrients (No late night snack) were consumed at 10 p.m. from Type 1 diabetic patients on an intensified conventional treatment regimen..
Other: No late night snack
The late night snack was one slice of whole meal rye bread containing approximately 20 g of carbohydrate.
Patient consumed no nutrients at late night.
Hypoglycemia
Hypoglycemia with a plasma glucose ≤ 50 mg/dl as determined with a standardized laboratory method
Time frame: 26 hours
Blood glucose profile
The blood glucose profile with and without a late-night snack . (standard blood glucose profiles with determinations at 6, 8, and 10 p.m, at midnight, at 2, 4, 6:45, 8:45 a.m., and at noon and 2, 6, and 8 p.m. of the following day).
Time frame: 26 hours
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Diabeteszentrum Bad Lauterberg im Harz