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Late Night Snack and Insulin Glargine

Primary Purpose

Type 1 Diabetes, Hypoglycemia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Late night snack
No late night snack
Sponsored by
Diabeteszentrum Bad Lauterberg im Harz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 1 Diabetes focused on measuring Hypoglycemia, Type 1 diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Diabeteszentrum Bad Lauterberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

With late night snack

Without late night snack

Arm Description

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.

Not nutrients (No late night snack) were consumed at 10 p.m. from Type 1 diabetic patients on an intensified conventional treatment regimen..

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

Full Information

First Posted
August 15, 2016
Last Updated
August 15, 2016
Sponsor
Diabeteszentrum Bad Lauterberg im Harz
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1. Study Identification

Unique Protocol Identification Number
NCT02871180
Brief Title
Late Night Snack and Insulin Glargine
Official Title
A Late Night Snack May be Necessary to Prevent Nocturnal Hyperglycemia in Type 1-diabetic Patients Using Insulin Glargine (LANTUS)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diabeteszentrum Bad Lauterberg im Harz

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Hypoglycemia
Keywords
Hypoglycemia, Type 1 diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
With late night snack
Arm Type
Other
Arm Description
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.
Arm Title
Without late night snack
Arm Type
Other
Arm Description
Not nutrients (No late night snack) were consumed at 10 p.m. from Type 1 diabetic patients on an intensified conventional treatment regimen..
Intervention Type
Dietary Supplement
Intervention Name(s)
Late night snack
Intervention Description
The late night snack was one slice of whole meal rye bread containing approximately 20 g of carbohydrate.
Intervention Type
Other
Intervention Name(s)
No late night snack
Intervention Description
Patient consumed no nutrients at late night.
Primary Outcome Measure Information:
Title
Hypoglycemia
Description
Hypoglycemia with a plasma glucose ≤ 50 mg/dl as determined with a standardized laboratory method
Time Frame
26 hours
Secondary Outcome Measure Information:
Title
Blood glucose profile
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A. Nauck, Prof.
Organizational Affiliation
St. Josef-Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diabeteszentrum Bad Lauterberg
City
Bad Lauterberg
State/Province
Niedersachsen
ZIP/Postal Code
37431
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Late Night Snack and Insulin Glargine

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