Clinical trial NCT04564911: GLucose Monitoring Programme SingaporE, Phase 2 (GLiMPSE2)
Official title: GLucose Monitoring Programme SingaporE, Phase 2(GLiMPSE2)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Flash Glucose Monitoring
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: National University Hospital, Singapore
name: SingHealth Polyclinics
name: National Healthcare Group Polyclinics
name: National University Polyclinics, Singapore
First posted: 2020-09-25
Enrollment: 206
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Adults (Age \>21 years) with Type 2 diabetes (HbA1c 7.5 to 10% for 2 consecutive readings over the preceding 9 months at time of enrolment)
2. Singapore Citizen or Permanent Resident
3. Treatment with diet and exercise alone or other glucose-lowering therapies except prandial insulin. GLP-1 agonists and / or basal insulin (NPH insulin, Insulin Lantus, Insulin Toujeo, Insulin Detemir) are permitted.
4. Self-reported regular blood glucose testing via CBG (more than 3/week)

Exclusion Criteria:

1. Age above 75 years
2. Type 1 diabetes, monogenic diabetes
3. Prandial insulin (quick-acting insulin or premixed insulin)
4. Cancer requiring treatment in the past 5 years
5. Chronic renal failure (eGFR\<45ml/min) or dialysis
6. Amputation of lower limbs (excluding toe amputations)
7. Bariatric surgery for weight loss
8. Current systemic treatment with steroids
9. Pregnancy, attempting pregnancy or lactation.
10. Haemolytic anaemia or haemoglobinopathy
11. Prior use of the flash glucose monitoring system for more than 3 times

Primary outcomes:
measure: Change from baseline HbA1c at week 24
timeFrame: 24 weeks
Secondary outcomes:
measure: Change from baseline Time in Range at week 26
timeFrame: 26 weeks
measure: Change in Baseline % Time Below Range at week 26
timeFrame: 26 weeks
measure: Change from baseline % CV glucose at week 26
timeFrame: 26 weeks
measure: Change in Weight from baseline at week 24
timeFrame: 24 weeks
measure: Change in Body Mass Index from baseline at week 24
timeFrame: 24 weeks
measure: Change in both systolic and diastolic blood pressure from baseline at week 24
timeFrame: 24 weeks
measure: Change in score from baseline using the Work productivity and daily activity impairment questionnaire
timeFrame: 24 weeks
measure: Change from baseline in Diabetes Distress Scale score
timeFrame: 24 weeks
measure: Change from baseline in EuroQol-5D-5L (5 level) utilities score.
timeFrame: 24 weeks
measure: Qualitative questionnaire
timeFrame: 24 weeks
measure: Number of individuals requiring medication up-titration from baseline to week 24
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pasir Ris Polyclinic
city: Singapore
country: Singapore
facility: National Healthcare Group
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: Singapore General Hospital
name: Daphne SL Gardner, MD
role: PRINCIPAL_INVESTIGATOR
References: