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,
American Diabetes Association Professional Practice Committee. 5. Facilitating Behavior Change and Well-being to Improve Health Outcomes: Standards of Medical Care in Diabetes-2022. Diabetes Care. 2022 Jan 1;45(Suppl 1):S60-S82. doi: 10.2337/dc22-S005. — View Citation
Barnard KD, Skinner TC, Peveler R. The prevalence of co-morbid depression in adults with Type 1 diabetes: systematic literature review. Diabet Med. 2006 Apr;23(4):445-8. doi: 10.1111/j.1464-5491.2006.01814.x. — View Citation
Bradley C, Plowright R, Stewart J, Valentine J, Witthaus E. The Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) evaluated in insulin glargine trials shows greater responsiveness to improvements than the original DTSQ. Health Qual Life Outcomes. 2007 Oct 10;5:57. doi: 10.1186/1477-7525-5-57. — View Citation
Brown SA, Kovatchev BP, Raghinaru D, Lum JW, Buckingham BA, Kudva YC, Laffel LM, Levy CJ, Pinsker JE, Wadwa RP, Dassau E, Doyle FJ 3rd, Anderson SM, Church MM, Dadlani V, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Kollman C, Beck RW; iDCL Trial Research Group. Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. N Engl J Med. 2019 Oct 31;381(18):1707-1717. doi: 10.1056/NEJMoa1907863. Epub 2019 Oct 16. — View Citation
Fisher L, Hessler D, Polonsky W, Strycker L, Masharani U, Peters A. Diabetes distress in adults with type 1 diabetes: Prevalence, incidence and change over time. J Diabetes Complications. 2016 Aug;30(6):1123-8. doi: 10.1016/j.jdiacomp.2016.03.032. Epub 2016 Apr 4. — View Citation
Fisher L, Hessler DM, Polonsky WH, Mullan J. When is diabetes distress clinically meaningful?: establishing cut points for the Diabetes Distress Scale. Diabetes Care. 2012 Feb;35(2):259-64. doi: 10.2337/dc11-1572. Epub 2012 Jan 6. — View Citation
Gold AE, MacLeod KM, Frier BM. Frequency of severe hypoglycemia in patients with type I diabetes with impaired awareness of hypoglycemia. Diabetes Care. 1994 Jul;17(7):697-703. doi: 10.2337/diacare.17.7.697. — View Citation
Hessler DM, Fisher L, Polonsky WH, Masharani U, Strycker LA, Peters AL, Blumer I, Bowyer V. Diabetes distress is linked with worsening diabetes management over time in adults with Type 1 diabetes. Diabet Med. 2017 Sep;34(9):1228-1234. doi: 10.1111/dme.13381. Epub 2017 Jun 18. — View Citation
Khan A, Choudhary P. Investigating the Association Between Diabetes Distress and Self-Management Behaviors. J Diabetes Sci Technol. 2018 Nov;12(6):1116-1124. doi: 10.1177/1932296818789721. Epub 2018 Aug 12. — View Citation
Kudva YC, Laffel LM, Brown SA, Raghinaru D, Pinsker JE, Ekhlaspour L, Levy CJ, Messer LH, Kovatchev BP, Lum JW, Beck RW, Gonder-Frederick L; iDCL Trial Research Group. Patient-Reported Outcomes in a Randomized Trial of Closed-Loop Control: The Pivotal International Diabetes Closed-Loop Trial. Diabetes Technol Ther. 2021 Oct;23(10):673-683. doi: 10.1089/dia.2021.0089. — View Citation
Lawton J, Blackburn M, Rankin D, Allen JM, Campbell FM, Leelarathna L, Tauschmann M, Thabit H, Wilinska ME, Elleri D, Hovorka R. Participants' Experiences of, and Views About, Daytime Use of a Day-and-Night Hybrid Closed-Loop System in Real Life Settings: Longitudinal Qualitative Study. Diabetes Technol Ther. 2019 Mar;21(3):119-127. doi: 10.1089/dia.2018.0306. Epub 2019 Feb 5. — View Citation
Leelarathna L, Choudhary P, Wilmot EG, Lumb A, Street T, Kar P, Ng SM. Hybrid closed-loop therapy: Where are we in 2021? Diabetes Obes Metab. 2021 Mar;23(3):655-660. doi: 10.1111/dom.14273. Epub 2020 Dec 20. — View Citation
Pandit AU, Bailey SC, Curtis LM, Seligman HK, Davis TC, Parker RM, Schillinger D, DeWalt D, Fleming D, Mohr DC, Wolf MS. Disease-related distress, self-care and clinical outcomes among low-income patients with diabetes. J Epidemiol Community Health. 2014 Jun;68(6):557-64. doi: 10.1136/jech-2013-203063. Epub 2014 Jan 31. — View Citation
Polonsky WH, Fisher L, Hessler D, Johnson N. Emotional Distress in the Partners of Type 1 Diabetes Adults: Worries About Hypoglycemia and Other Key Concerns. Diabetes Technol Ther. 2016 May;18(5):292-7. doi: 10.1089/dia.2015.0451. Epub 2016 Feb 9. — View Citation
Reddy P, Philpot B, Ford D, Dunbar JA. Identification of depression in diabetes: the efficacy of PHQ-9 and HADS-D. Br J Gen Pract. 2010 Jun;60(575):e239-45. doi: 10.3399/bjgp10X502128. — View Citation
Strandberg RB, Graue M, Wentzel-Larsen T, Peyrot M, Rokne B. Relationships of diabetes-specific emotional distress, depression, anxiety, and overall well-being with HbA1c in adult persons with type 1 diabetes. J Psychosom Res. 2014 Sep;77(3):174-9. doi: 10.1016/j.jpsychores.2014.06.015. Epub 2014 Jul 9. — View Citation
Trief PM, Cibula D, Delahanty LM, Weinstock RS. Depression, stress, and weight loss in individuals with metabolic syndrome in SHINE, a DPP translation study. Obesity (Silver Spring). 2014 Dec;22(12):2532-8. doi: 10.1002/oby.20916. Epub 2014 Sep 24. — View Citation
* 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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