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Completed

NCT Number: NCT02204839

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Behavior Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Immune System Diseases Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Facility, Royal Victoria Infirmary

Newcastle upon Tyne, Tyne and Wear, NE1 4LP, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Basal insulin dose

Drug

Other names: (Glargine, Lantus, Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk)

Primary outcomes

  1. 24 hour blood glucose area under the curve

    Time frame: 24 hours

    24 hour blood glucose area under the curve

Secondary outcomes

  1. Ketonaemia

    Time frame: 60 minutes before and 24 hours post-exercise

    Blood beta-hydroxybutyrate concentrations

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Collaborators

  • Newcastle University

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 30, 2014
Registry last updated
Jan 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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