Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04564911 |
Other study ID # |
GLiMPSE2 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 22, 2020 |
Est. completion date |
December 30, 2023 |
Study information
Verified date |
December 2023 |
Source |
Singapore General Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
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.
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.