Type 1 Diabetes Clinical Trial
Official title:
Can Maximising Time in Range Using Automated Insulin Delivery and a Low Carbohydrate Diet Restore the Glucagon Response to Hypoglycaemic in Type 1 Diabetes?
Verified date | April 2024 |
Source | University of Edinburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Almost all people who have had type 1 diabetes for 5 years have a defect in secretion of the hormone Glucagon. This hormone is involved in the body's response to low blood glucose (hypoglycaemia). It works by releasing glucose stores from the liver to bring the blood glucose back to normal. This defect therefore increases the risk of severe hypoglycaemia. The reason for this Glucagon defect in people with Type 1 diabetes is currently unknown. This study aims to look at the Glucagon response to hypoglycaemia in 24 people with type 1 diabetes to ascertain whether tight blood glucose control over a period of time improves this response. The investigators aim to achieve good blood glucose control using new generation Automated Insulin Delivery systems (AIDs). This system is made of: an insulin pump, a continuous glucose monitor (CGM) and an algorithm that allows adjustment of insulin delivery based on the blood glucose readings from the CGM. This is the most up to date technology that there is in the management of type 1 diabetes. However, people using this technology often still have problems with high blood glucose after eating. To ensure a very good blood glucose control participants will also follow a low carbohydrate diet to prevent this blood glucose rise after meals. The Glucagon response to low blood glucose will be measured at zero and eight months using the hyperinsulinaemic hypoglycaemic clamp technique.
Status | Active, not recruiting |
Enrollment | 17 |
Est. completion date | December 26, 2025 |
Est. primary completion date | December 26, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility | Inclusion Criteria: - Participants with Type 1 diabetes with C-peptide levels less than 200pmol/L. - Type 1 diabetes for 5 years or more. - HbA1c greater than or equal to 53 mol/mol. - Normal renal function. - Normal thyroid function. - Gold Score 4-7 (indicating impaired awareness of hypoglycaemia) - Willingness to monitor blood ketones daily. - Use of freestyle libre device is permitted at study entry and may be continued in participants in group 1 Exclusion Criteria: - Current use of a non-approved closed loop / AID system or those on a predictive low glucose suspend insulin pump. - Proliferative retinopathy - Regular use of real time CGM in the preceding 3 months. - History of Diabetic ketoacidosis in the preceding 6 months. - Severe hypoglycaemic episode requiring external assistance in the preceding 6 months. - Inability to safely use technology used in this study (e.g. impaired vision, memory or dexterity that prevents safe operation of CGM or insulin pump.) - Inability to support the technology requirements for the study (e.g. unable to upload study device at home) - History of Haemophilia, Cystic Fibrosis, pancreatic disease or complete pancreatectomy, ischaemic heart disease, epilepsy or hypoglycaemia induced seizure - History of severe reaction or allergy to adhesive necessary to this study. - Unable to adhere to study timetable. - Unable to give informed consent. - Pregnancy. We will perform a pregnancy test on all eligible participants at baseline. - Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas. These may lower insulin requirements and predispose to diabetic ketoacidosis. - Concurrent use of medication that may affect blood glucose such as SSRIs - A condition, which in the opinion of the investigator, would put the patient or study at risk - HbA1c greater than or equal to 75 mmol/mol |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Edinburgh Royal Infirmary/University of Edinburgh | Edinburgh |
Lead Sponsor | Collaborator |
---|---|
University of Edinburgh | DexCom, Inc., NHS Lothian, Tandem Diabetes Care, Inc., The Leona M. and Harry B. Helmsley Charitable Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change in plasma glucagon levels (pmol/L) measured during normoglycaemic and hypoglycaemia | Measured at baseline and each glucose plateau in a stepped hyperinsulinaemic hypoglycaemic clamp study at study start and study end | 8 months | |
Secondary | Time in glycaemic range (3.9-10mmol/L) | Percentage time spent in target glycaemic range. | 8 months | |
Secondary | Time spent below the target glycaemic range (<3.9mmol/L) | Percentage of time spent below the target glycaemic range | 8 months | |
Secondary | Time spent above the target glycaemic range (>10mmol/L) | Percentage of time spent above the target glycaemic range | 8 months | |
Secondary | The change in plasma cortisol (nmol/L) levels measured during normoglycaemic and hypoglycaemia | Measured at baseline and each glucose plateau in a stepped hyperinsulinaemic hypoglycaemic clamp study at study start and study end | 8 months | |
Secondary | The change in plasma adrenaline (nmol/L) levels measured during normoglycaemic and hypoglycaemia | Measured at baseline and each glucose plateau in a stepped hyperinsulinaemic hypoglycaemic clamp study at study start and study end | 8 months | |
Secondary | The change in plasma noradrenaline (nmol/L) levels measured during normoglycaemic and hypoglycaemia | Measured at baseline and each glucose plateau in a stepped hyperinsulinaemic hypoglycaemic clamp study at study start and study end | 8 months | |
Secondary | Endogenous glucose production | Measured with stable isotope studies using D2 glucose and D5 glycerol | 8 months | |
Secondary | HbA1c | Difference between baseline and study end | 8 months | |
Secondary | Change in quality of life at trial entry and end. | Measured using the EQ5D-5L- a quality of life questionnaire comprising of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension consists of five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant ticks the box most relevant to them at the time of taking the questionnaire. This response is converted into a 1 digit number and the 5 numbers from a domain can be combined to describe the participant's health state. This questionnaire will be completed at trial entry and then at trial end. | 8 months | |
Secondary | Change in emotional distress related to diabetes at trial entry and end. | Diabetes Distress Scale (DDS-1)- a 28-item self-reporting scale. Each item can be scored from 1 (not a problem) to 6 (a very serious problem). This questionnaire will be completed at study entry and study end. | 8 months | |
Secondary | Attitude to diabetes technologies | Measured using the Diabetes Technology Questionnaire- a 30 item questionnaire. The participant ranks each item from Very Much (1) to Not at all (5). Participants will complete this questionnaire at study entry and study end. Also assessed using the Diabetes Technology Attitudes Survey- a 5 item questionnaire. The participant ranks each item from Strongly Disagree (1) to Strongly Agree (5). | 8 months | |
Secondary | Change in fear of hypoglycaemic | Measured using the Hypoglycaemia Fear Survey (HFS)- this survey consists of two subscales- Behaviour and Worry. There are 28 items in the survey that the participant ranks from Never (0) to Almost Always (4). Participants will complete this questionnaire at study entry and study end. | 8 months | |
Secondary | Change in confidence of managing hypoglycaemia | Measured using the Hypoglycaemic Confidence Scale- this is a 9 item scale. The participant rates each item from Not Confident at All to Very Confident. Participants will complete this questionnaire at study entry and study end. | 8 months | |
Secondary | Hypoglycaemia awareness | Measured during each clamp study using the Edinburgh Hypoglycaemic Scale- this is a 17 item scale of symptoms of hypoglycaemia. The participant ranks on a scale from Not at all (1) to A Great Deal (7) whether they are experiencing each symptom at the time of the questionnaire being completed. | 8 months | |
Secondary | Trial Making Test | Measured during each plateau in a stepped hypoglycaemic clamp study at study entry and study end. Difference in score between plateaus and at trial entry and end. | 8 months | |
Secondary | Digit Span Test | Measured during each plateau in a stepped hypoglycaemic clamp study at study entry and study end. Difference in score between plateaus and at trial entry and end. | 8 months | |
Secondary | Digit Symbol Substitution Test | Measured during each plateau in a stepped hypoglycaemic clamp study at study entry and study end. Difference in score between plateaus and at trial entry and end. | 8 months | |
Secondary | Four Choice Reaction Time Test | Measured during each plateau in a stepped hypoglycaemic clamp study at study entry and study end. Difference in score between plateaus and at trial entry and end. | 8 months |
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