Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04304963
Other study ID # 259415
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date October 31, 2022

Study information

Verified date July 2023
Source King's College London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hypoglycaemia or low blood glucose, and its fear are major barriers to achieving optimal glucose control. New technology, such as continuous glucose monitors (CGM), help to better identify hypoglycaemia and develop strategies to avoid it. These devices measure glucose in the skin, rather than in the blood, and provide information not only on how low glucose is, but also for how long. Recent studies showed that over half of episodes of low glucose with these systems are not recognised by people with diabetes, and even people without diabetes have sensor values that are below the current thresholds for hypoglycaemia [ low blood glucose] that we measure with traditional monitors. In this study, the investigators will evaluate the impact of symptomatic as well as asymptomatic episodes of low sensor glucose on a variety of clinical, patient-related and health economic outcomes such as mood, quality of sleep and productivity. The investigators will test different levels and durations of low sensor glucose to identify the one that best matches episodes that are symptomatic to best define hypoglycaemia using these systems. The investigators will also look at factors that influence this such as sleep or activity as well as diabetes management behaviours (such as insulin dosing, carb counting, etc). At the end of this study, the investigators will be able to provide a better definition of clinically relevant low sensor glucose readings that will help inform clinical as well as academic interpretation of CGM data.


Recruitment information / eligibility

Status Completed
Enrollment 602
Est. completion date October 31, 2022
Est. primary completion date October 31, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: 1. Age 18 - 85 years 2. HbA1c 5 - 10% [31 - 86 mmol/mol] 3. Confirmed diagnosis of type 1 or type 2 diabetes 4. Using > 1 injection of insulin / day or insulin pump. 5. Ability to provide written informed consent 6. Performing regular SMBG [ > 1 / day on a 4-week download] . For those using flash or continuous glucose monitoring, this should be used at least 70% of the time. 7. At least 1 episode of hypoglycaemia [ either biochemical or symptomatic] in the last month 8. On stable therapy for at least 3 months. 9. Willing to complete study procedures including wearing the Fitbit and CGM devices and completing the EMA questionnaires on the uMotif app three times a day for 10 weeks ( we expect minimum 80% data completeness) Exclusion Criteria: 1. Concurrent conditions that can affect glucose readings [renal impairment GFR < 30 ml/min, hepatic impairment, untreated adrenal or thyroid insufficiency, as judged by the investigator. 2. Severe cognitive impairment or psychological illness that can impair performance of EMA tasks, visual impairment that will preclude use of the EMA or sensors. 3. Severe psychiatric / psychological illness including extreme fear of hypo- or hyper- glycaemia ( in the opinion of the investigator) 4. Pregnant or plans for pregnancy in the next 6 months 5. Use of automated insulin delivery systems such as closed loop or automated threshold suspend or predictive low glucose suspend insulin pumps. 6. Known allergies to adhesives required for the CGM systems 7. People who work regular night shifts 8. Any other condition which in the opinion of the study team would impair their ability to complete the study

Study Design


Intervention

Other:
NO intervention - observational study
NO intervention - observational study

Locations

Country Name City State
United Kingdom King's College London London

Sponsors (16)

Lead Sponsor Collaborator
King's College London Abbott Diabetes Care, Cambridge University Hospitals NHS Foundation Trust, Innovative Medicines Initiative, International Diabetes Federation, Juvenile Diabetes Research Foundation, Medical University of Graz, Medtronic Diabetes, Ninewells Hospital, Nordsjaellands Hospital, Novo Nordisk A/S, Radboud University Medical Center, Sheffield Teaching Hospitals NHS Foundation Trust, The Leona M. and Harry B. Helmsley Charitable Trust, University Hospital, Montpellier, University of Southern Denmark

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary LIG optimum detection of hypoglycemia To determine the Low Interstitial Glucose (LIG) parameters that have the optimum performance for detection and identification of patient-reported-hypoglycemia (PRH); ?LIG?_PRH (h_opt,t_opt). week 10
Secondary Secondary outcome 1 To evaluate the impact of symptomatic and asymptomatic hypoglycaemia on different domains of Quality of Life (QoL) and health economic variables measured by a bespoke mobile phone application.
We will use the definition of LIG identified in the primary objective, ?LIG?_PRH (h_opt,t_opt), to evaluate the impact of symptomatic and asymptomatic hypoglycaemia on various outcome variables. To do this, we will divide the days into one of 4 categories LIG-PRH- :no hypoglycaemia LIG+PRH- :asymptomatic biochemical hypoglycaemia ( CGM false positive) LIG+PRH+ :symptomatic biochemical hypoglycaemia LIG-PRH+ :symptomatic without biochemical hypoglycaemia (CGM false negative) We will then compare the scores in different domains collected on the app ( eg reported mood, quality of sleep, alertness, productivity, time off work) between the 4 categories.
week 10
Secondary Secondary outcome 2 To evaluate the impact of adding co-variates such as change of glucose for 30 minutes prior to the event and area under the curve to the threshold and duration parameters to see if this can improve the sensitivity and specificity of ?LIG?_PRH (h_opt,t_opt), week 10
Secondary Secondary outcome 3 To evaluate the impact on these optimal parameters [?LIG?_PRH (h_opt,t_opt ] on Type of diabetes ( Type 1 with normal awareness, Type 2, Type 1 with impaired awareness) Awake vs sleeping ( as determined by Fitbit) Usual Mode of glucose monitoring (SMBG vs Flash vs CGM) Rate of ?LIG?_PRH during the study week 10
Secondary Secondary outcome 4 To evaluate the impact of the rate of ?LIG?_PRH over the whole study duration on Rate of Patient reported hypoglycaemia ( non-severe) Rate of severe hypoglycaemia Overall EQ-5D-5L scores WPAI ( productivity) PROMIS - (sleep quality) Hypo fear scores Baseline C-peptide levels week 10
Secondary Secondary outcome 5 To determine the parameters (threshold and duration) of low interstitial glucose (LIG) that best identify a pre-specified reduction/ change in QoL. [ 0.07 reduction in EQ-5D-5L] ?LIG?_(EQ-5D) (h_opt,t_opt). week 10
Secondary Secondary outcome 6 To determine the parameters ( threshold and duration) of low interstitial glucose (LIG) that best identify a pre-specified health economic outcome. [1.5 hour loss of effective work/ activity] ?LIG?_productivity (h_opt,t_opt). week 10
Secondary Secondary outcome 7 Determining the predictors of ?LIG?_PRH by looking at variables such as mean glucose, variability, activity (step count and intensity). week 10
Secondary Secondary outcome 8 We will evaluate the impact of activity ( step count) on the risk of ?LIG?_PRH the following night. A generalized linear mixed models (GLMM) with step count as the independent variable and the rate of LIG_PRH as the response variable will address this research question week 10
Secondary Secondary outcome 9 We will try to understand some of the causes of hypoglycaemia. To do this we will look at the 4 hours prior to every available ?LIG?_PRH (h_opt,t_opt) and PRH and describe the category of events (if also insulin data is available) by classifying them into those with Bolus within range [ < 10 mmol/l] within 4 hours Bolus and correction [ > 10 mmol/l ] within 4 hours No bolus within 4 hours Activity [ as identified by the Fitbit charge 3] within 2 hours. week 10
Secondary Secondary outcome 10 Evaluating the effect of personality (assessed by DS-14) on number and severity of hypoglycaemia and the effect of hypoglycaemia on quality of life measures week 10
See also
  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
Completed NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
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 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