NCT02204839

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 15, 2015

Status Verified

January 1, 2015

Enrollment Period

1 year

First QC Date

July 25, 2014

Last Update Submit

January 14, 2015

Conditions

Type 1 Diabetes Mellitus

Keywords

T1DM, Exercise, Hypoglycaemia

Outcome Measures

Primary Outcomes (1)

  • 24 hour blood glucose area under the curve

    24 hour blood glucose area under the curve

    24 hours

Secondary Outcomes (1)

  • Ketonaemia

    60 minutes before and 24 hours post-exercise

Study Arms (1)

Basal dose reduction

EXPERIMENTAL

Total daily basal (Glargine, Lantus, Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk) reduction of 20% versus normal basal dose.

Drug: Basal insulin dose

Interventions

Basal insulin doseDRUG
Also known as: (Glargine, Lantus, Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk)
Basal dose reduction

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Facility, Royal Victoria Infirmary

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

Location

Related Publications (2)

  • Campbell MD, West DJ, O'Mahoney LL, Pearson S, Kietsiriroje N, Holmes M, Ajjan RA. The relative contribution of diurnal and nocturnal glucose exposures to HbA1c in type 1 diabetes males: a pooled analysis. J Diabetes Metab Disord. 2022 Mar 31;21(1):573-581. doi: 10.1007/s40200-022-01015-1. eCollection 2022 Jun.

    PMID: 35673512DERIVED

  • Campbell MD, Walker M, Bracken RM, Turner D, Stevenson EJ, Gonzalez JT, Shaw JA, West DJ. Insulin therapy and dietary adjustments to normalize glycemia and prevent nocturnal hypoglycemia after evening exercise in type 1 diabetes: a randomized controlled trial. BMJ Open Diabetes Res Care. 2015 May 12;3(1):e000085. doi: 10.1136/bmjdrc-2015-000085. eCollection 2015.

    PMID: 26019878DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Motor ActivityHypoglycemia

Interventions

Insulin GlargineInsulin Detemir

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Daniel J West, PhD

    Northumbria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2014

First Posted

July 30, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

January 15, 2015

Record last verified: 2015-01

Locations

GB(1)