Diabetes Mellitus, Type 2NCT02666521
Hypoglycaemia in People With Type 2 Diabetes in Primary Care
An observational study of Diabetes Mellitus, Type 2 and Hypoglycemia, run by University of Leicester at 1 site in United Kingdom.
Trial summary
Despite type 2 diabetes comprising the majority of cases of diabetes, the overall frequency of hypoglycaemia in this group has not been as carefully documented as in type 1 diabetes, particularly in relation to the clinical use of individual therapies in primary care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypoglycemia
- How many people
- 2,327 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jul 2012to 30 Jun 2017
- 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: Adults with Type 2 diabetes managed in primary care
Who may be able to join
- Confirmed diagnosis of type 2 diabetes mellitus
- Diagnosis at least 6 months prior to recruitment
- Registered at participating general practice
- Aged ≥ 18 years old
- On one of the following treatment regimens:
- metformin only
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- sulphonylurea based (not on insulin or incretin-based therapy)
- insulin based (not on sulphonylurea, GLP-1 or DPP-4)
- incretin or incretin based therapy, DPP-4 or GLP-1 (not on sulphonylureas or insulin)
- HbA1c <9.0% at last reading Willingness to self-report episodes of hypoglycaemia and undertake home blood glucose self-monitoring for 12-months
- Confirmed diagnosis of type 2 diabetes mellitus
- Diagnosis at least 6 months prior to recruitment
- Registered at a general practice within Leicestershire, Rutland or Northamptonshire
- Treatment for type 2 diabetes includes oral hypoglycaemic drugs and/ or insulin
Who cannot join
- Participant managed exclusively in secondary care
- Severe diabetic complications e.g. corrected visual acuity less than 6/12 in both eyes, major limb amputation or severe peripheral sensory neuropathy
- History of seizures unrelated to hypoglycaemia
- Severe systemic disease unrelated to diabetes
- Pregnancy
- Any reason why the participant may not be able to understand instructions or be unable or unwilling to co-operate with the study staff e.g. mental incapacity, language barriers
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- CROSS-SECTIONAL STUDY
- Any reason why the participant may not be able to understand instructions or be unable or unwilling to co-operate with the study staff e.g. mental incapacity, language barriers
- Aged ≥ 18 years old
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Diabetes Research Centre, University of Leicester
Leicester, LE5 4PW
About this study
Official title: Study to Determine the Frequency and Associated Predictors of Hypoglycaemia in People With Type 2 Diabetes Mellitus Managed in Primary Care
Despite type 2 diabetes comprising the majority of cases of diabetes, the overall frequency of hypoglycaemia in this group has not been as carefully documented as in type 1 diabetes, particularly in relation to the clinical use of individual therapies in primary care.
The aim of this study is to provide robust data on the frequency and severity of hypoglycaemia in people with type 2 diabetes managed in primary care, and assess and explore associated risk factors.
Read the detailed description
Background - previous studies have provided robust evidence on the link between intensive therapy and increased frequency of hypoglycaemia in people with type 1 diabetes. Despite type 2 diabetes comprising the majority of cases of diabetes, the overall frequency of hypoglycaemia in this group has not been as carefully documented as in type 1 diabetes, particularly in relation to the clinical use of individual therapies in primary care.
Recent prospective studies suggest that hypoglycaemia occurs more frequently than was previously thought for people with type 2 diabetes, particularly those treated with insulin and sulphonylureas. An increasingly elderly population, and earlier initiation of insulin and other newer therapies and treatment combinations, may influence the risk and severity of hypoglycaemic episodes.
The overall aim is to undertake research that provides robust data on the frequency and severity of hypoglycaemia in people with type 2 diabetes managed in primary care, and assess and explore associated risk factors.
PROSPECTIVE STUDY Aims - to prospectively evaluate the self-reported frequency and severity of hypoglycaemia in people with type 2 diabetes managed in primary care (stratified by participant treatment regime); to investigate the associated clinical and demographic predictors of hypoglycaemia.
Methods - we will undertake a prospective, observational cohort study. Firstly, general practices will be approached to participate in the study, with an aim of recruiting around 20 practices throughout the UK. All recruited sites will receive relevant study training for the purposes of recruiting participants and collecting/recording research data. Participating general practices will then identify potentially eligible individuals on their practice register; individuals will be invited via a study invitation pack sent in the post or given in person when they attend the practice. Individuals expressing an interest will be invited to attend an appointment at their general practice where informed consent will be obtained and baseline data collected (demographic, bio-medical and self-completion questionnaires). Participants will be provided with relevant study materials (glucose monitoring diaries, hypoglycaemia recording forms, and a blood glucose meter and strips) and asked to measure their blood glucose and record any episodes of hypoglycaemia, over a period of 12-months. Repeat biomedical and self-completion questionnaire data will be collected at 12-months follow-up.
The overall sample size for the prospective study is 422, based on recruiting a quota of participants on the following treatment regimens: 1) metformin only (n=62); 2) sulphonylurea based (n=140); 3) insulin based (n=140); and 4) incretin based (Dipeptidyl peptidase-4 (DPP4) or Glucagon-like peptide-1 (GLP-1)), (n=80). Practices will be asked to continue recruitment until targets are met for each of the treatment groups.
CROSS SECTIONAL STUDY Aim - to provide data on the prevalence of hypoglycaemia in people with type 2 diabetes who are managed in primary care and explore associated risk factors.
Methods - approach for participation will be made when potential volunteers attend for a planned appointment for diabetes care (e.g. diabetes annual review, diabetic retinopathy screening), through poster advertisement at the site. Their healthcare professional will also explain that there is a researcher at the clinic who is recruiting individuals with type 2 diabetes to take part in a research study. The researcher will then approach potential volunteers to provide a brief verbal explanation of the study, followed by a written participant information sheet for them to read. Subsequently, for individuals who volunteer to participate, they will be asked to sign a consent form and then given a questionnaire to self-complete (at their appointment or take home and post back to the research team). In addition, a researcher will obtain biomedical data from participants' medical records; no data will be collected until at least 48 hours has passed from the time informed consent was obtained, to allow time for participants who may change their mind about taking part.
The anticipated recruitment target for the cross-sectional study is to recruit up to 2000 participants.
- Conditions
- Diabetes Mellitus, Type 2, Hypoglycemia
- Keywords
- Primary Health Care
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypoglycemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of mild hypoglycaemic episodes, compared by treatment regimen
self-report
Measured: at 12-months (Prospective)
Frequency of mild hypoglycaemic episodes
self-report
Measured: Baseline (Cross-sectional);
Secondary outcomes (2)
Frequency of severe hypoglycaemic episodes, compared by treatment regimen
self-report
Measured: at 12-months (Prospective)
Frequency of severe hypoglycaemic episodes
self-report
Measured: Baseline (Cross-sectional);
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study start20 Jul 2012
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Other
- Time perspective
- Other
- Enrolment
- 2,327 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- Primary Care Diabetes Society, UK
- Responsible party
- Sponsor
- Investigators
- Prof Kamlesh Khunti, PhD, FRCGP, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666521
- Sponsor's protocol ID
- 0204
- Other IDs
- UKCRN ID 12188
- Status last verified
- Jan 2016
- First submitted
- 20 Jan 2016
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Determine the Frequency and Associated Predictors of Hypoglycaemia in People With Type 2 Diabetes Mellitus Managed in Primary Care
- ClinicalTrials.gov ID
- NCT02666521
- Acronym / sponsor ID
- 0204
- Conditions
- Diabetes Mellitus, Type 2, Hypoglycemia
- Keywords
- Primary Health Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,327 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- Primary Care Diabetes Society, UK
- Study start
- 20 Jul 2012 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 28 Jan 2016 (estimated)
- 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.
Despite type 2 diabetes comprising the majority of cases of diabetes, the overall frequency of hypoglycaemia in this group has not been as carefully documented as in type 1 diabetes, particularly in relation to the clinical use of individual therapies in primary care.
The aim of this study is to provide robust data on the frequency and severity of hypoglycaemia in people with type 2 diabetes managed in primary care, and assess and explore associated risk factors.
Detailed description
Background - previous studies have provided robust evidence on the link between intensive therapy and increased frequency of hypoglycaemia in people with type 1 diabetes. Despite type 2 diabetes comprising the majority of cases of diabetes, the overall frequency of hypoglycaemia in this group has not been as carefully documented as in type 1 diabetes, particularly in relation to the clinical use of individual therapies in primary care.
Recent prospective studies suggest that hypoglycaemia occurs more frequently than was previously thought for people with type 2 diabetes, particularly those treated with insulin and sulphonylureas. An increasingly elderly population, and earlier initiation of insulin and other newer therapies and treatment combinations, may influence the risk and severity of hypoglycaemic episodes.
The overall aim is to undertake research that provides robust data on the frequency and severity of hypoglycaemia in people with type 2 diabetes managed in primary care, and assess and explore associated risk factors.
PROSPECTIVE STUDY Aims - to prospectively evaluate the self-reported frequency and severity of hypoglycaemia in people with type 2 diabetes managed in primary care (stratified by participant treatment regime); to investigate the associated clinical and demographic predictors of hypoglycaemia.
Methods - we will undertake a prospective, observational cohort study. Firstly, general practices will be approached to participate in the study, with an aim of recruiting around 20 practices throughout the UK. All recruited sites will receive relevant study training for the purposes of recruiting participants and collecting/recording research data. Participating general practices will then identify potentially eligible individuals on their practice register; individuals will be invited via a study invitation pack sent in the post or given in person when they attend the practice. Individuals expressing an interest will be invited to attend an appointment at their general practice where informed consent will be obtained and baseline data collected (demographic, bio-medical and self-completion questionnaires). Participants will be provided with relevant study materials (glucose monitoring diaries, hypoglycaemia recording forms, and a blood glucose meter and strips) and asked to measure their blood glucose and record any episodes of hypoglycaemia, over a period of 12-months. Repeat biomedical and self-completion questionnaire data will be collected at 12-months follow-up.
The overall sample size for the prospective study is 422, based on recruiting a quota of participants on the following treatment regimens: 1) metformin only (n=62); 2) sulphonylurea based (n=140); 3) insulin based (n=140); and 4) incretin based (Dipeptidyl peptidase-4 (DPP4) or Glucagon-like peptide-1 (GLP-1)), (n=80). Practices will be asked to continue recruitment until targets are met for each of the treatment groups.
CROSS SECTIONAL STUDY Aim - to provide data on the prevalence of hypoglycaemia in people with type 2 diabetes who are managed in primary care and explore associated risk factors.
Methods - approach for participation will be made when potential volunteers attend for a planned appointment for diabetes care (e.g. diabetes annual review, diabetic retinopathy screening), through poster advertisement at the site. Their healthcare professional will also explain that there is a researcher at the clinic who is recruiting individuals with type 2 diabetes to take part in a research study. The researcher will then approach potential volunteers to provide a brief verbal explanation of the study, followed by a written participant information sheet for them to read. Subsequently, for individuals who volunteer to participate, they will be asked to sign a consent form and then given a questionnaire to self-complete (at their appointment or take home and post back to the research team). In addition, a researcher will obtain biomedical data from participants' medical records; no data will be collected until at least 48 hours has passed from the time informed consent was obtained, to allow time for participants who may change their mind about taking part.
The anticipated recruitment target for the cross-sectional study is to recruit up to 2000 participants.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with Type 2 diabetes managed in primary care
Key inclusion criteria (14 listed)
- Confirmed diagnosis of type 2 diabetes mellitus
- Diagnosis at least 6 months prior to recruitment
- Registered at participating general practice
- Aged ≥ 18 years old
- On one of the following treatment regimens:
Key exclusion criteria (9 listed)
- Participant managed exclusively in secondary care
- Severe diabetic complications e.g. corrected visual acuity less than 6/12 in both eyes, major limb amputation or severe peripheral sensory neuropathy
- History of seizures unrelated to hypoglycaemia
- Severe systemic disease unrelated to diabetes
- Pregnancy
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
Frequency of mild hypoglycaemic episodes, compared by treatment regimen
Time frame: at 12-months (Prospective)
self-report
Frequency of mild hypoglycaemic episodes
Time frame: Baseline (Cross-sectional);
self-report
2 secondary outcomes
Frequency of severe hypoglycaemic episodes, compared by treatment regimen
Time frame: at 12-months (Prospective)
Frequency of severe hypoglycaemic episodes
Time frame: Baseline (Cross-sectional);
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 2 May 2018.
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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.
Prof Kamlesh Khunti, PhD, FRCGP principal investigator
University of Leicester
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 Mellitus, Type 2 and Hypoglycemia, run by University of Leicester 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 14 inclusion and 9 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 2 May 2018. 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?
Frequency of mild hypoglycaemic episodes, compared by treatment regimen (time frame: at 12-months (Prospective)). The study lists 2 primary outcomes in all. 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 2 May 2018.