Status:
COMPLETED
Individualised Postprandial Glucose Responses in Type 1 Diabetes
Lead Sponsor:
University of Sunderland
Conditions:
Type 1 Diabetes
Diabetes Complications
Eligibility:
All Genders
18-70 years
Phase:
NA
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 thera...
Detailed Description
Recruitment: Participants will be recruited using advertisements through university channels. The investigators will also approach local and national diabetes charities (Diabetes UK, JDRF) who the inv...
Eligibility Criteria
Inclusion
- Gender/sex, race/ethnicity, sexual orientation, and religion are not exclusion criteria for this study
- 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.
Exclusion
- 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;
- Unfamiliar and not currently using the carbohydrate-counting method for determining mealtime insulin dose;
- Currently pregnant or planning on becoming pregnant during study involvement;
- Presence of overt diabetes complications including end stage renal failure requiring dialysis;
- Presenting with hypoglycaemia unawareness assessed through a combination of the Clarke and Gold methods; Recent (\<6-months) history of diabetic ketoacidosis (DKA);
- Presenting with medical conditions relating to a haematological disorder, gut mobility or digestion;
- Presenting with a history of anorexia, bulimia, or any other disordered eating;
- Presenting with a history of deep vein thrombosis;
- Presenting with a history of heart attack or stroke within 6 months prior to recruitment;
- History of malignancy;
- Presence of existing medical or psychiatric conditions likely to interfere with the study;
- Presenting with dietary allergies or intolerances likely to interfere with the study;
- Unable to understand written English and provide written informed consent.
Key Trial Info
Start Date :
November 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05231642
Start Date
November 30 2021
End Date
December 20 2022
Last Update
October 23 2023
Active Locations (1)
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1
University of Sunderland
Sunderland, Tyne and Wear, United Kingdom