Individualised Postprandial Glucose Responses in Type 1 Diabetes

NCT05231642 | Completed

• 1 other identifier: IRAS308018
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Type 1 diabetes (T1D) is a lifelong disease which stops the body from producing insulin - an important hormone that controls blood sugar (glucose) levels. People with T1D use insulin replacement therapy, usually in the form of injections, to help control blood glucose levels, however keeping glucose levels within normal ranges is usually a challenge. Mealtime glucose control is fundamental to good diabetes management and are an important contributor to long-term diabetes complications. However, many individuals experience variability in glucose levels around mealtimes. The objective of this study is to establish whether and which parameters are important predictors of mealtime glucose levels in people with T1D. The investigators will monitor glucose levels using the latest glucose monitoring technology and collect blood samples to:

1. 1.Characterise changes in glucose levels in individuals with T1D in response to different meals
2. 2.Determine whether and what food characteristics and personal factors are linked to individual glucose responses to different meals.

Conditions

Type 1 Diabetes; Diabetes Complications; Postprandial Hyperglycemia

Outcome Measures

Primary Outcomes (1)

• Glucose AUC

  Glucose Area Under the Curve calculated using the trapezoid method (mmol.L.hr)

  4 hours

Secondary Outcomes (10)

• Hypoglycaemia

  4 hours

• Hyperglycaemia

  4 hours

• Mean glucose

  4 hours

• Glycaemic variability

  4 hours

• Glycaemic variability

  4 hours

Study Arms (2)

Low GI

EXPERIMENTAL

Consumption of standardised low-GI mixed-macronutrient breakfast-based meal followed by a standardised low-GI mixed-macronutrient lunch meal 4 hours later.

Other: Nutritional Interventional

High GI

EXPERIMENTAL

Consumption of a standardised high-GI mixed-macronutrient breakfast-based meal followed by a standardised high-GI mixed-macronutrient lunch meal 4 hours later.

Other: Nutritional Interventional

Interventions

Nutritional Interventional OTHER

Individualised postprandial glucose and vascular risk responses

High GI; Low GI

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• A diagnosis of T1D for a minimum of 5 years;
• Currently treated on a stable insulin regimen for a minimum of 6 months consisting of continuous subcutaneous insulin infusion (CSII) therapy or multiple daily injections (MDI) of a combination of rapid-acting and long-acting insulin;
• Familiar and currently using the carbohydrate-counting method for determining mealtime insulin dose;
• Not currently pregnant;
• No overt diabetes complications including end stage renal failure requiring dialysis;
• Free from hypoglycaemia unawareness assessed through a combination of the Clarke64 and Gold65 methods66;
• No recent (\<6-months) history of diabetic ketoacidosis (DKA);
• Free from medical conditions relating to a haematological disorder, gut mobility or digestion; No history of anorexia, bulimia, or any other disordered eating;
• No history of deep vein thrombosis;
• No history of heart attack or stroke within 6 months prior to recruitment;
• No history of malignancy; No existing medical or psychiatric conditions likely to interfere with the study;
• No dietary allergies or intolerances likely to interfere with the study;
• Able to understand written English and provide written informed consent.
• A diagnosis of T1D for less than 5 years;
• Not currently treated on a stable insulin regimen for more than 6 months consisting of continuous subcutaneous insulin infusion (CSII) therapy or multiple daily injections (MDI) of a combination of rapid-acting and long-acting insulin;

Sponsors & Collaborators

• University of Sunderland: lead

Study Sites (1)

University of Sunderland

Sunderland, Tyne and Wear, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Complications; Hyperglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single centre, randomised and counter-balanced, two-arm cross-over study.

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: February 9, 2022
• Study Start: November 30, 2021
• Primary Completion: December 10, 2022
• Study Completion: December 20, 2022
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available upon completion of the study for a total duration of 5 years.
• Access Criteria: Submission of a research proposal to the lead contact. The submission will be reviewed prior to approval for IPD sharing.

Locations

GB (1)