Impact of Hybrid Closed Loop Systems in People With Type I Diabetes

NCT05348499 | Unknown

• 1 other identifier: 0841
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes; Insulin Pump Therapy; Patient Reported Outcomes

Keywords

Type 1 Diabetes; Hybrid Closed Loop Insulin Pump; Patient Reported Outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• In people with type 1 diabetes, Patient Health Questionnaire-9 scores

  Between 3 and 12 months after starting HCL therapy.

• In people with type 1 diabetes, Hypoglycaemia Confidence Scale

  Between 3 and 12 months after starting HCL therapy

• In people with type 1 diabetes, description of the Insulin Dosing Systems: Perceptions, Ideas, Reflections and Expectations questionnaire results

  Between 3 and 12 months after starting HCL therapy

• In people with type 1 diabetes, Diabetes Treatment Satisfaction Questionnaire results

  Between 3 and 12 months after starting HCL therapy

• In people with type 1 diabetes, Euro Qol 5 dimensions-5 Levels (EQ-5D-5L) scores

  Between 3 and 12 months after starting HCL therapy

Study Arms (2)

People with T1D participating in the NHS funded pilot of HCL therapy

The questionnaires to be administered to people with type 1 diabetes, over 3 months after starting hybrid closed loop insulin pump therapy as part of the NHS pilot are: * Gold Score * Patient health questionnaire-9 (PHQ-9) * Diabetes distress score-T1 * Hypoglycaemia confidence scale * INSPIRE survey * EQ5D5L * Diabetes Treatment Satisfaction Questionnaire (DTSQs) and Diabetes Treatment Satisfaction Questionnaire change (DTSQc) version * Bespoke questionnaire using domains that are important to people with diabetes * System usability scale Approximately 15 participants with type 1 diabetes will be asked to participate in semi-structured qualitative interviews at \>3 months after the person with type 1 diabetes starts the HCL.

Other: Questionnaire/Interview

Partners of people with T1D participating in the NHS funded pilot of HCL therapy

Partners of people with type 1 diabetes will be invited to complete three validated questionnaires that have been specifically developed for partners and one bespoke questionnaire: * Diabetes distress score - partner * Hypoglycaemia confidence scale - partner * INSPIRE - partner * Bespoke questionnaire Approximately 15 partners of people with type 1 diabetes will be asked to participate in semi-structured qualitative interviews at \>3 months after the person with type 1 diabetes starts the HCL.

Other: Questionnaire/Interview

Interventions

Questionnaire/Interview OTHER

Questionnaire/Interview

Partners of people with T1D participating in the NHS funded pilot of HCL therapy; People with T1D participating in the NHS funded pilot of HCL therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The NHS has recently announced a pilot roll out of commercially available hybrid closed loop systems to up to 1000 people living with type 1 diabetes who are currently have suboptimal glucose control HbA1c 8.5% (70mmol/mol) or greater despite current treatment with insulin pumps as well as flash glucose monitoring (or continuous glucose monitoring). This pilot will include 21 adult sites listed. Up to 50 people with type 1 diabetes at each site will be offered the opportunity to use a commercially approved HCL system for up to a year. We will recruit people with type 1 diabetes and their partners enrolled on the NHS pilot to our study.

You may qualify if:

• Capacity to provide informed consent
• ≥18 years of age
• Diagnosis of type I diabetes
• Comprehension of English - able to understand study material, participate in the interview and complete the online questionnaires
• On HCL therapy as part of the NHS pilot

You may not qualify if:

• \. Diagnosis Type II or other form of diabetes

Sponsors & Collaborators

• University of Leicester: lead
• JDRF UK: collaborator

Study Sites (1)

Leicester Diabetes Research Centre

Leicester, United Kingdom

RECRUITING

Related Publications (17)

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• 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.

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  PMID: 16620276 BACKGROUND

• 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.

  PMID: 26859072 BACKGROUND

• 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.

  PMID: 25149027 BACKGROUND

• 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.

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• 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.

  PMID: 22228744 BACKGROUND

• 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.

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• 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.

  PMID: 28498610 BACKGROUND

• 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.

  PMID: 30720338 BACKGROUND

• 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.

  PMID: 31618560 BACKGROUND

• 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.

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• 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.

  PMID: 34115959 BACKGROUND

• 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.

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• 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.

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• 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.

  PMID: 17927832 BACKGROUND

• 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.

  PMID: 30101610 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Surveys and Questionnaires; Interviews as Topic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 27, 2022
• Study Start: November 14, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)