Late Night Snack and Insulin Glargine

Type 1 Diabetes Clinical Trial

Official title: A Late Night Snack May be Necessary to Prevent Nocturnal Hyperglycemia in Type 1-diabetic Patients Using Insulin Glargine (LANTUS)

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes

• NCT number: NCT02871180
• Study type: Interventional
• Source: Diabeteszentrum Bad Lauterberg im Harz
• Status: Completed
• Phase: N/A
• Start date: March 2003