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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02871180
• Other study ID #: Late night snack & Lantus
• Status: Completed
• Phase: N/A
• First received: August 15, 2016
• Last updated: August 15, 2016
• Start date: March 2003

Study information

• Verified date: August 2016
• Source: Diabeteszentrum Bad Lauterberg im Harz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes

• Basal insulin substitution with insulin glargine at least 3 month

Exclusion Criteria:

• Severe disorders

• Severe and clinical significant gastroparesis

• History of pancreatitis or pancreatic cancer

• Severe Liver disorder (liver enzymes > three times upper normal limit)

• Pregnancy

• Drug- or alcohol abuse

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

Intervention

Dietary Supplement:
• Late night snack
The late night snack was one slice of whole meal rye bread containing approximately 20 g of carbohydrate.

Other:
• No late night snack
Patient consumed no nutrients at late night.

Locations

Country	Name	City	State
Germany	Diabeteszentrum Bad Lauterberg	Bad Lauterberg	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
Diabeteszentrum Bad Lauterberg im Harz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoglycemia	Hypoglycemia with a plasma glucose = 50 mg/dl as determined with a standardized laboratory method	26 hours	No
Secondary	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).	26 hours	No