Combined Basal-bolus Insulin and Post-exercise Carbohydrate Feeding Strategy in T1DM

Type 1 Diabetes Mellitus Clinical Trial

Official title:

The Metabolic and Glycaemic Effects of a Combined Basal-Bolus Insulin Reduction And Carbohydrate Feeding Strategy For Evening Exercise in Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02204839
• Other study ID #: West-Walker3
• Status: Completed
• Phase: N/A
• First received: July 25, 2014
• Last updated: January 14, 2015
• Start date: January 2014
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesise that reducing basal insulin dose (Glargine, Lantus, Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk), whilst employing current carbohydrate feeding and rapid-acting insulin dose recommendations will protect patients with type 1 diabetes from early- and late-onset hypoglycaemia following evening time exercise.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Aged between 18-50 years old (male or female).

• Free from any diabetes related complications (apart from mild background diabetic retinopathy).

• HbA1c <8.5%.

• Not taking any prescribed medication other than insulin, and treated with a stable insulin regimen composed of a combination of slow/long acting insulin (glargine or detemir) and fast-acting insulin analogues (lispro or aspart), for a minimum of 6 months before the start of the study.

• Demonstrate normal cardiac function in response to exercise.

Exclusion Criteria:

• Aged younger than 18, or older than 50 years.

• Suffering from, or diagnosed with a diabetes related complication (apart from mild background diabetic retinopathy).

• HbA1c >8.5%.

• Currently taking prescribed medication, and not currently treated with a stable basal bolus regimen composed of a combination glargine or determir, and lispro or aspart for at least 6 months before the start of the study.

• Failure to demonstrate normal cardiopulmonary responses during exercise, or have a medical condition which could prevent completion of exercise or be exacerbated because of.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Basal insulin dose

Locations

Country	Name	City	State
United Kingdom	Clinical Research Facility, Royal Victoria Infirmary	Newcastle upon Tyne	Tyne and Wear

Sponsors (2)

Lead Sponsor	Collaborator
Northumbria University	Newcastle University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hour blood glucose area under the curve	24 hour blood glucose area under the curve	24 hours	No
Secondary	Ketonaemia	Blood beta-hydroxybutyrate concentrations	60 minutes before and 24 hours post-exercise	No