Late Night Snack and Insulin Glargine

Not Applicable

Completed

• Conditions: Type 1 Diabetes; Hypoglycemia
• Interventions: Other: No late night snack; Dietary Supplement: Late night snack

• Registration Number: NCT02871180
• Lead Sponsor: Diabeteszentrum Bad Lauterberg im Harz

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.

Study Timeline

• Study Start: 2003-03
• Status Verified: 2016-08
• Primary Completion: 2016-08
• Study First Submitted: 2016-08-15
• Study First Submitted QC: 2016-08-15
• Last Update Submitted: 2016-08-15
• Study First Posted: 2016-08-18
• Last Update Posted: 2016-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Without late night snack	No late night snack	Not nutrients (No late night snack) were consumed at 10 p.m. from Type 1 diabetic patients on an intensified conventional treatment regimen..
With late night snack	Late night snack	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.

Primary Outcome Measures

Name	Time	Method
Hypoglycemia	26 hours	Hypoglycemia with a plasma glucose ≤ 50 mg/dl as determined with a standardized laboratory method

Secondary Outcome Measures

Name	Time	Method
Blood glucose profile	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).

Trial Locations

Locations (1)

Diabeteszentrum Bad Lauterberg; 🇩🇪 Bad Lauterberg, Niedersachsen, Germany