The Effect of Injectable Therapies on Quality of Life in Diabetes

NCT03222245 | Completed

• 1 other identifier: V5.0
• Study Type: observational
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

This study is only open to sites in the Wessex CRN. The aim of diabetes treatment is to achieve and maintain as optimal blood glucose levels as possible to prevent unpleasant symptoms associated with high blood sugars and long-term complications of diabetes. This can be achieved with oral tablets, subcutaneous injectable diabetes therapies such as insulin or GLP-1 analogues. Injectable therapies can significantly improve glucose control, but the counter to this might be an increased treatment burden, patient and clinician's inertia to initiate injectable treatments and the potential side effects of the medications. These treatment aspects may critically affect patients' health related quality of life and satisfaction with treatment which can powerfully influence patients' compliance and self-management behaviours. This is an observational cohort study and its overall aim is to compare the health status, quality of life (QOL) and treatment satisfaction in two cohorts of patients with type 2 diabetes - those treated with oral diabetes drugs (nonexposed group) and those on subcutaneous injectable therapies (exposed group). The changes in the above parameters will be measured by applying three questionnaires to both groups of participants at baseline and after 6 months of treatment:

1. 1.ADDQoL measures diabetes specific quality of life
2. 2.DTSQ measures treatment satisfaction
3. 3.SF-36 measures overall health status

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in quality of life

  Change in ADDQoL score Change in DTSQ score

  26 weeks

Secondary Outcomes (1)

• Change in HbA1c

  26 weeks

Study Arms (2)

Exposed group

This group consists of participants identified as needing to start injectable therapy within 1 month from the recruitment date (50% insulin and 50% GLP-1 analogues)

Non-exposed group

This group consists of participants treated with oral anti- hyperglycaemic agents (OAHAs) and their combinations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Local population of patients with type 2 diabetes from both the primary and secondary care setting.

You may qualify if:

• Individuals with a coded diagnosis of type 2 diabetes diagnosed at least 1 year prior to start of the study to minimise bias present from psychological effect of diagnosis
• Age 18 y inclusive and above
• Participant is willing and able to give informed consent for participation in the study
• Participants currently treated with OAHAs and their combinations
• Completely naïve to self-administration of sc injections as part of diabetes treatment or for any other medical condition
• Exposed group will consist of participants identified as needing to start and starting sc injectable therapy (insulin or GPL-1 analogue) within 1 month of recruitment.
• Non-exposed group will consist of participants managed with diet or OAHA therapies and their combinations, who require an addition of a new OAHA to their current therapy to intensify their diabetes control

You may not qualify if:

• Current diagnosis means that their predicted lifespan is shorter than duration of the study
• Medical condition that may affect participants' quality of life eg diagnosis of cancer, undergoing chemotherapy
• History of or current diagnosis of depression
• Planning of moving out of area before completion of the study
• Pregnant and intention of becoming pregnant
• Unable to give consent

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead
• AstraZeneca: collaborator

Study Sites (1)

Portsmouth Hospital NHS Trust

Portsmouth, UK, PO6 3LY, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sharon Allard

  Portsmouth Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 19, 2017
• Study Start: June 30, 2017
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)