Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Study to Determine the Frequency and Associated Predictors of Hypoglycaemia in People With Type 2 Diabetes Mellitus Managed in Primary Care
Verified date | January 2016 |
Source | University of Leicester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 2327 |
Est. completion date | June 30, 2017 |
Est. primary completion date | June 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
PROSPECTIVE STUDY Inclusion Criteria: - 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: 1. metformin only 2. sulphonylurea based (not on insulin or incretin-based therapy) 3. insulin based (not on sulphonylurea, GLP-1 or DPP-4) 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 Exclusion Criteria: - 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 CROSS-SECTIONAL STUDY Inclusion criteria: - 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 Exclusion criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Diabetes Research Centre, University of Leicester | Leicester |
Lead Sponsor | Collaborator |
---|---|
University of Leicester | Primary Care Diabetes Society, UK |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Hypoglycaemia symptoms | The Edinburgh Hypoglycaemia Scale | Baseline (Cross-sectional); Baseline and 12-months (Prospective) | |
Other | Awareness of hypoglycaemia | Hypoglycaemia Awareness Scale | Baseline (Cross-sectional); Baseline and 12-months (Prospective) | |
Other | Fear of hypoglycaemia | Hypoglycaemia Fear Survey | Baseline (Cross-sectional); Baseline and 12-months (Prospective) | |
Other | Health related quality of life | EQ-5D | Baseline (Cross-sectional); Baseline and 12-months (Prospective) | |
Other | Anxiety and depression | Hospital Anxiety and Depression Scale | Baseline (Cross-sectional); Baseline and 12-months (Prospective) | |
Other | Incidence and severity of hypoglycaemic episodes | Hypoglycaemia recording form and diary | up to 12-months (Prospective study group only) | |
Primary | Frequency of mild hypoglycaemic episodes, compared by treatment regimen | self-report | at 12-months (Prospective) | |
Primary | Frequency of mild hypoglycaemic episodes | self-report | Baseline (Cross-sectional); | |
Secondary | Frequency of severe hypoglycaemic episodes, compared by treatment regimen | self-report | at 12-months (Prospective) | |
Secondary | Frequency of severe hypoglycaemic episodes | self-report | Baseline (Cross-sectional); |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05666479 -
CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
|
||
Completed |
NCT05647083 -
The Effect of Massage on Diabetic Parameters
|
N/A | |
Active, not recruiting |
NCT05661799 -
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
|
N/A | |
Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
Completed |
NCT02836704 -
Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)
|
Phase 4 | |
Completed |
NCT01819129 -
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
|
Phase 3 | |
Completed |
NCT04562714 -
Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy
|
N/A | |
Completed |
NCT02009488 -
Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1 | |
Completed |
NCT05896319 -
Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2
|
N/A | |
Recruiting |
NCT05598203 -
Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes
|
N/A | |
Completed |
NCT05046873 -
A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People
|
Phase 1 | |
Terminated |
NCT04090242 -
Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
|
N/A | |
Completed |
NCT04030091 -
Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
|
Phase 4 | |
Completed |
NCT03620357 -
Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)
|
N/A | |
Completed |
NCT03604224 -
A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
|
||
Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
Completed |
NCT03620890 -
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
|
Phase 4 | |
Withdrawn |
NCT05473286 -
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
|
||
Not yet recruiting |
NCT05029804 -
Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
|
N/A | |
Completed |
NCT04531631 -
Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes
|
Phase 2 |