Skip to main content
OpenTrials
Completed

NCT Number: NCT02871180

Late Night Snack and Insulin Glargine

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabeteszentrum Bad Lauterberg

Bad Lauterberg im Harz, Lower Saxony, 37431, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Late night snack

Dietary Supplement

The late night snack was one slice of whole meal rye bread containing approximately 20 g of carbohydrate.

No late night snack

Other

Patient consumed no nutrients at late night.

Primary outcomes

  1. Hypoglycemia

    Time frame: 26 hours

    Hypoglycemia with a plasma glucose ≤ 50 mg/dl as determined with a standardized laboratory method

Secondary outcomes

  1. Blood glucose profile

    Time frame: 26 hours

    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).

Sponsors and collaborators

Lead sponsor

Diabeteszentrum Bad Lauterberg im Harz

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2016
First posted
Aug 18, 2016
Registry last updated
Aug 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.