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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Drug: Basal insulin dose


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Basal dose reduction<br>Total daily basal (Glargine, Lantus, Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk) reduction of 20% versus normal basal dose. | Drug: Basal insulin dose<br> <br> * Other names: (Glargine, Lantus, Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour blood glucose area under the curve | 24 hour blood glucose area under the curve | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ketonaemia | Blood beta-hydroxybutyrate concentrations | 60 minutes before and 24 hours post-exercise | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T1DM, Exercise, Hypoglycaemia