Late Night Snack and Insulin Glargine

NCT02871180 | Completed

• 1 other identifier: Late night snack & Lantus
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes; Hypoglycemia

Keywords

Hypoglycemia; Type 1 diabetes

Outcome Measures

Primary Outcomes (1)

• Hypoglycemia

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

  26 hours

Secondary Outcomes (1)

• Blood glucose profile

  26 hours

Study Arms (2)

With late night snack

OTHER

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

Without late night snack

OTHER

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

Interventions

Late night snack DIETARY_SUPPLEMENT

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

With late night snack

No late night snack OTHER

Patient consumed no nutrients at late night.

Without late night snack

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 diabetes
• Basal insulin substitution with insulin glargine at least 3 month

You may not qualify if:

• 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

Sponsors & Collaborators

• Diabeteszentrum Bad Lauterberg im Harz: lead

Study Sites (1)

Diabeteszentrum Bad Lauterberg

Bad Lauterberg im Harz, Lower Saxony, 37431, Germany

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

• Michael A. Nauck, Prof.

  St. Josef-Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Michael A. Nauck

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: August 18, 2016
• Study Start: March 1, 2003
• Primary Completion: August 1, 2016
• Last Updated: August 18, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)