Type 1 Diabetes Clinical Trial
— ProHCLOfficial title:
Mixed Methods Study Exploring the Impact of Hybrid Closed-loop Systems on Patient Reported Outcomes in People With Type I Diabetes and Their Partners
NCT number | NCT05348499 |
Other study ID # | 0841 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 14, 2021 |
Est. completion date | September 1, 2023 |
Verified date | May 2023 |
Source | University of Leicester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Type 1 diabetes requires people with type 1 diabetes to constantly monitor their blood glucose and adjust their insulin doses to try and keep glucose levels in range. Hybrid closed loop systems (also called artificial pancreas) consist of a sensor that continuously measures glucose levels, an algorithm that then decides every few minutes how much insulin to deliver and an insulin pump that then delivers the insulin. These systems have been shown in observational and randomized studies to improve glucose levels and have high levels of user satisfaction. The National Health Service (NHS) in the UK has launched a pilot for up to 1,000 people with type 1 diabetes to trial these devices for up to 1 year and the results of that pilot will be audited by clinical teams. This study will recruit people from that pilot and use well validated as well as bespoke questionnaires to assess the impact of this technology on various key patient reported outcomes such as depression, diabetes related distress and fear of hypoglycemia (low blood glucose). We will invite a small number of participants to take part in semi-structured interviews to gain a more detailed understanding of the benefits and challenges of using these devices, and the impact they have on people living with type 1 diabetes. We know that living with a partner with type 1 diabetes can also have a negative impact on quality of life, and so we will invite partners of people using the hybrid closed loops systems to complete some validated and bespoke questionnaires. A small sample will also be invited to participate in interviews. The data from this real-world study of the impact of hybrid closed loop systems on patient reported outcomes will be of value to clinicians, people with type 1 diabetes and policy makers in understanding the value of these systems to people with type 1 diabetes and their families.
Status | Recruiting |
Enrollment | 350 |
Est. completion date | September 1, 2023 |
Est. primary completion date | September 1, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Capacity to provide informed consent 2. =18 years of age 3. Diagnosis of type I diabetes 4. Comprehension of English - able to understand study material, participate in the interview and complete the online questionnaires 5. On HCL therapy as part of the NHS pilot Exclusion Criteria: 1. Diagnosis Type II or other form of diabetes |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Leicester Diabetes Research Centre | Leicester |
Lead Sponsor | Collaborator |
---|---|
University of Leicester | JDRF UK |
United Kingdom,
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diabetes Distress Score-T1 score in people with type 1 diabetes | DDS T1 is an indicator of overall diabetes distress (average of 28 items, rated 1 to 6 on a scale).
Average score <2.0 = indicates little/no distress. Average score 2.0 to 2.9 = indicates moderate distress. Average score > 3.0 = indicates high distress. |
Between 3 and 12 months after starting HCL therapy | |
Secondary | In people with type 1 diabetes, Patient Health Questionnaire-9 scores | Designed to assess depression severity. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. | Between 3 and 12 months after starting HCL therapy. | |
Secondary | In people with type 1 diabetes, Hypoglycaemia Confidence Scale | A nine-item self-reporting questionnaire. Designed to explore how a person with diabetes feels about their capacity to prevent issues related to hypoglycemia.
Items are ranked on a 4 point scale based on the individuals confidence at preventing hypoglycemia in specific situations : = not confident at all = a little confident = moderately confident = very confident The results can be added together to provide a total scale score. |
Between 3 and 12 months after starting HCL therapy | |
Secondary | In people with type 1 diabetes, description of the Insulin Dosing Systems: Perceptions, Ideas, Reflections and Expectations questionnaire results | Questionnaire designed to assess the impact of using HCL on dimensions of psychosocial functioning and quality of life . | Between 3 and 12 months after starting HCL therapy | |
Secondary | In people with type 1 diabetes, Diabetes Treatment Satisfaction Questionnaire results | Designed to assess peoples satisfaction with their diabetes therapy, score 0-36; higher scores reflect higher satisfaction. | Between 3 and 12 months after starting HCL therapy | |
Secondary | In people with type 1 diabetes, Euro Qol 5 dimensions-5 Levels (EQ-5D-5L) scores | The EQ Vas score is scored on a scale numbered 0-100 where 100 is the best health you can imagine and 0 means the worst health you can imagine. | Between 3 and 12 months after starting HCL therapy | |
Secondary | In people with type 1 diabetes, descriptive results of the system usability scale for HCL therapy. | A well recognized scoring system used to assess the usability of devices. | Between 3 and 12 months after starting HCL therapy | |
Secondary | In partners of people with type 1 diabetes, partner Diabetes Distress Score | Yields a total diabetes distress score for partners of people with type 1 diabetes:
A mean item score of <2.0 = little or no distress. A mean item score of 2.0 - 2.9 = moderate distress. A mean item score > 3.0 = high distress. |
Between 3 and 12 months after starting HCL therapy | |
Secondary | In partners of people with type 1 diabetes, partner Insulin Dosing Systems: Perceptions, Ideas, Reflections and Expectations questionnaire results. | Questionnaire designed to assess the partner of a person with type 1 diabetes experience of using HCL. | Between 3 and 12 months after starting HCL therapy | |
Secondary | In partners of people with type 1 diabetes, partner Hypoglycaemia Confidence Scale | 2-item self-report scale exploring how partners of adults with type 1 diabetes feel about their capacity to help their partner with type 1 diabetes prevent problems related to hypoglycaemia.
Ranked on a 4 point scale based on the partners confidence at helping their partner preventing hypoglycemia in specific situations: = not confident at all = a little confident = moderately confident = very confident The results can be added together to provide a total scale score. |
Between 3 and 12 months after starting HCL therapy | |
Secondary | Descriptive results of person with type 1 diabetes and partner bespoke questionnaire | A bespoke questionnaire exploring themes which have been inadequately addressed in the previous questionnaires. | Between 3 and 12 months after starting HCL therapy | |
Secondary | Thematic analysis of semi-structured interviews to explore the impact of HCL systems on different aspects of life and daily functioning of people with type 1 diabetes and their partners. | Between 3 and 12 months after starting HCL therapy |
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