Clinical Trials Logo

Clinical Trial Summary

Many with type 2 diabetes (T2D) remain sub-optimally controlled. Structured programmes requiring dietary and lifestyle intervention have been shown to improve control but are time-and labour-intensive. The role for self-monitoring of blood glucose with capillary blood glucose (CBG) readings is uncertain. The use of flash glucose monitoring (FGM) with education may effect improvements in awareness and self-management behaviour and hence glycaemic control. The investigators aim to compare the effects of FGM versus CBG fingersticks in the context of a structured education programme over a 6-month period in adults with type 2 diabetes. 200 adults (>21y) with sub-optimally controlled T2D (7.5-10%) on either diet-controlled, oral glucose lowering drugs or background insulin will be enrolled and randomised into the intervention arm (FGM and education) or control arm (capillary glucose fingersticks and education). The intervention arm will monitor glucose using FGM continuously for 6 weeks and intermittently thereafter up to 24 weeks. The control group will monitor glucose using CBG fingersticks up to 24 weeks. During the intervention period(0-24w), both arms will undergo the same schedule of visits (-2w, 0w, 8w, 16w, 24w) and 6 education sessions. Both groups will be followed up at weeks 38 and 52. Primary outcome is HbA1c change from baseline at 24 weeks. This study will provide novel data on the use of FGM versus CBG in Type 2 diabetes and its impact on glycaemic control.


Clinical Trial Description

Up to 200 adults will be recruited from 5 different sites in Singapore. Following screening, consent and enrolment, all participants wear a blinded flash glucose monitoring system that is masked to the user and asked to continue testing capillary glucose readings at least once daily for 2 weeks (week -2 to week -1).Participants who are able to wear the sensor for the 2 weeks, and are monitoring capillary glucose levels at least 70% of the time for the 2 weeks (≥10 readings/2weeks), will carry on to be randomised to intervention or control group (week 0). Upon fulfilling the criteria of blinded sensor wear of 2 weeks and 70% capillary glucose monitoring over 2 weeks, participants will be randomised into the control or the intervention arm, using web- based retrieval of randomisation allocation. At baseline (week 0), all participants in both groups will receive baseline education on diabetes self-management, including blood glucose targets, role and timing of diabetes medications, and individualised education on macronutrient composition of meals and the goals of nutritional therapy in type 2 diabetes. Both groups will use the blinded FGM data at baseline for education. In total, both groups will receive 6 education sessions over the 24 week period, delivered by diabetes nurse educators or nurses and dietitians. The diabetes educators and physicians will be aligned towards a standardised curriculum for consistency of education through a train-the-trainer workshop. Participants randomised to the control arm will receive an education package and be given education on how to self-manage glucose levels using a standard capillary blood glucose device. They will be encouraged to test blood glucose readings at least twice a day but preferably 4 times daily. Participants randomised to the intervention arm will wear the flash glucose monitoring system, and will be given education on how to use sensor glucose data for self-management. Flash glucose monitoring will be used continuously for 6 weeks. From week 6 to week 24, the frequency of use of flash glucose monitoring will be reduced to one sensor every 4 weeks. The intervention period is for 24 weeks, followed by an observation period up to 52 weeks. After the 24-week intervention period, participants from both arms will wear a blinded sensor for the last 2 weeks of the intervention period (week 25 to week 26). During the observation period (weeks 24 to 52), participants in both arms will be encouraged to continue monitoring glucose levels. Medication titrations will be left to the discretion of the primary physician. Physician consults will be at weeks 0, 8, 24, 38, 52. There will be no medication up-titration at week 0 although the physician may choose to optimize medications if needed: e.g. moving basal from bedtime to the morning to reduce the risk of nocturnal hypoglycemia or switching from a sulphonylurea agent to an alternative oral medication to reduce the risk of hypoglycaemia. If down-titration of medications is required, the reduction/cessation of sulphonylurea agents or insulin therapy will be encouraged to alleviate the risk of hypoglycaemia and promote weight loss. If there is no improvement in glycemic control or deterioration of glycaemic control at weeks 8 and 16 (laboratory HbA1c more than of equal to 8.5% for consecutive readings, one laboratory HbA1c more than or equal to 10% or a 2% point HbA1c increase from previous visit), medications may be up-titrated. The use of agents which do not increase the risk of hypoglycaemia and promote weight loss will be encouraged. If prandial insulin or premixed insulin is added to the treatment regimen from week 8 onwards, subjects will still remain within the study and be included in the analysis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04564911
Study type Interventional
Source Singapore General Hospital
Contact
Status Active, not recruiting
Phase N/A
Start date December 22, 2020
Completion date December 30, 2023

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
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