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Late Night Snack and Insulin Glargine

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02871180
Enrollment
20
Registered
2016-08-18
Start date
2003-03-31
Completion date
Unknown
Last updated
2016-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoglycemia, Type 1 Diabetes

Keywords

Hypoglycemia, Type 1 diabetes

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.

Interventions

DIETARY_SUPPLEMENTLate night snack

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

OTHERNo late night snack

Patient consumed no nutrients at late night.

Sponsors

Diabeteszentrum Bad Lauterberg im Harz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hypoglycemia26 hoursHypoglycemia with a plasma glucose ≤ 50 mg/dl as determined with a standardized laboratory method

Secondary

MeasureTime frameDescription
Blood glucose profile26 hoursThe 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).

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026