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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02204839

Enrollment

Registered

2014-07-30

Start date

2014-01-31

Completion date

2015-01-31

Last updated

2015-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

T1DM, Exercise, Hypoglycaemia

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 insulin dose recommendations will protect patients with type 1 diabetes from early- and late-onset hypoglycaemia following evening time exercise.

Interventions

DRUGBasal insulin dose

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
24 hour blood glucose area under the curve	24 hours	24 hour blood glucose area under the curve

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026