Status:

COMPLETED

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

Lead Sponsor:

Northumbria University

Collaborating Sponsors:

Newcastle University

Conditions:

Type 1 Diabetes Mellitus

Eligibility:

MALE

18-50 years

Phase:

NA

Brief 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 ins...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

January 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2015

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT02204839

Start Date

January 1 2014

End Date

January 1 2015

Last Update

January 15 2015

Active Locations (1)

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1

Clinical Research Facility, Royal Victoria Infirmary

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