The Effect of Exercise on Blood Glucose Levels in Patients With Type 1 Diabetes: A Comparison of 3 Long-acting Insulins

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes

• Registration Number: NCT00313742
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this research is to assess the impact of three basal (long-acting) insulin treatments on blood glucose levels in people with type 1 diabetes when performing physical exercise.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-11
• Study First Submitted QC: 2006-04-11
• Study First Posted: 2006-04-12
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Type 1 Diabetes
• Current basal-bolus insulin therapy
• HbA1c < 10%
• BMI < 32 kg/m2

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Exclusion Criteria

• Proliferative Retinopathy / Maculopathy
• Recurrent major hypoglycaemias
• Impaired hepatic or renal function
• Cardiac Problems
• Uncontrolled hypertension

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
The difference between plasma glucose concentrations immediately pre-exercise and the minimum plasma glucose concentrations (nadir) in the period 0-150 min following exercise	following 4 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Plasma glucose pre-exercise & post-exercise
Hypoglycaemia episodes (major and minor episodes) during exercise, afterwards & from end of study until 07:30 the following morning
Plasma glucose profile post-exercise
Incidence of adverse events during the trial