DiabetesNCT03222245
The Effect of Injectable Therapies on Quality of Life in Diabetes
An observational study of Diabetes, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 256 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jun 2017to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Local population of patients with type 2 diabetes from both the primary and secondary care setting.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth Hospital NHS Trust
Portsmouth, UK, PO6 3LY
About this study
Official title: The Effect of Injectable Therapies on Health Status, Quality of Life and Treatment Satisfaction in Patients With Type 2 Diabetes: Prospective Observational Cohort Study
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.
Read more
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:
- ADDQoL measures diabetes specific quality of life
- DTSQ measures treatment satisfaction
- SF-36 measures overall health status
Study duration is six months for each participant and over this period participants will receive three telephone or face to face contacts (based on their preference) with the research team. The questionnaires will be posted to participants at baseline and at 6 months and will be completed in paper form and returned to research team in pre-paid selfaddressed envelopes.
It is hoped that this study will provide valuable understanding of the effect of injectable therapies on QOL and treatment satisfaction in our local population with type 2 diabetes which can then be carefully factored into clinical decisions when initiating or intensifying diabetes treatments.
Read the detailed description
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:
- ADDQoL measures diabetes specific quality of life
- DTSQ measures treatment satisfaction
- SF-36 measures overall health status
Study duration is six months for each participant and over this period participants will receive three telephone or face to face contacts (based on their preference) with the research team. The questionnaires will be posted to participants at baseline and at 6 months and will be completed in paper form and returned to research team in pre-paid selfaddressed envelopes.
It is hoped that this study will provide valuable understanding of the effect of injectable therapies on QOL and treatment satisfaction in our local population with type 2 diabetes which can then be carefully factored into clinical decisions when initiating or intensifying diabetes treatments.
- Conditions
- Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life
Change in ADDQoL score Change in DTSQ score
Measured: 26 weeks
Secondary outcomes (1)
Change in HbA1c
Change in HbA1c
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start30 Jun 2017
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Sharon Allard, Principal investigator, Portsmouth Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222245
- Sponsor's protocol ID
- V5.0
- Status last verified
- Apr 2023
- First submitted
- 14 Jul 2017
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Injectable Therapies on Health Status, Quality of Life and Treatment Satisfaction in Patients With Type 2 Diabetes: Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT03222245
- Acronym / sponsor ID
- V5.0
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Collaborators
- AstraZeneca
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 19 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- ADDQoL measures diabetes specific quality of life
- DTSQ measures treatment satisfaction
- SF-36 measures overall health status
Study duration is six months for each participant and over this period participants will receive three telephone or face to face contacts (based on their preference) with the research team. The questionnaires will be posted to participants at baseline and at 6 months and will be completed in paper form and returned to research team in pre-paid selfaddressed envelopes.
It is hoped that this study will provide valuable understanding of the effect of injectable therapies on QOL and treatment satisfaction in our local population with type 2 diabetes which can then be carefully factored into clinical decisions when initiating or intensifying diabetes treatments.
Detailed description
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:
- ADDQoL measures diabetes specific quality of life
- DTSQ measures treatment satisfaction
- SF-36 measures overall health status
Study duration is six months for each participant and over this period participants will receive three telephone or face to face contacts (based on their preference) with the research team. The questionnaires will be posted to participants at baseline and at 6 months and will be completed in paper form and returned to research team in pre-paid selfaddressed envelopes.
It is hoped that this study will provide valuable understanding of the effect of injectable therapies on QOL and treatment satisfaction in our local population with type 2 diabetes which can then be carefully factored into clinical decisions when initiating or intensifying diabetes treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Local population of patients with type 2 diabetes from both the primary and secondary care setting.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in quality of life
Time frame: 26 weeks
Change in ADDQoL score Change in DTSQ score
1 secondary outcome
Change in HbA1c
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Allard principal investigator
Portsmouth Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.