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

Primary Purpose

Type 1 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Basal insulin dose

About this trial

This is an interventional basic science trial for Type 1 Diabetes Mellitus focused on measuring T1DM, Exercise, Hypoglycaemia

Eligibility Criteria

18 Years - 50 Years (Adult)MaleDoes not accept 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.

Sites / Locations

Clinical Research Facility, Royal Victoria Infirmary

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Basal dose reduction

Arm Description

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

Outcomes

Primary Outcome Measures

24 hour blood glucose area under the curve

Secondary Outcome Measures

Ketonaemia

Blood beta-hydroxybutyrate concentrations

Full Information

NCT ID

NCT02204839

First Posted

July 25, 2014

Last Updated

January 14, 2015

Sponsor

Northumbria University

Collaborators

Newcastle University

1. Study Identification

Unique Protocol Identification Number

NCT02204839

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Northumbria University

Collaborators

Newcastle University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

Keywords

T1DM, Exercise, Hypoglycaemia

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Basal dose reduction

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Basal insulin dose

Other Intervention Name(s)

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

Primary Outcome Measure Information:

Title

24 hour blood glucose area under the curve

Description

24 hour blood glucose area under the curve

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Ketonaemia

Description

Blood beta-hydroxybutyrate concentrations

Time Frame

60 minutes before and 24 hours post-exercise

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel J West, PhD

Organizational Affiliation

Northumbria University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Research Facility, Royal Victoria Infirmary

City

Newcastle upon Tyne

State/Province

Tyne and Wear

ZIP/Postal Code

NE1 4LP

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

35673512

Citation

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.

Results Reference

derived

PubMed Identifier

26019878

Citation

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.

Results Reference

derived

Learn more about this trial

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

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