Status:
UNKNOWN
Flash CONtinous Glucose Monitoring in TRansition to Outpatient: Libre for Type 2 Diabetes Mellitus (CONTROL-DM)
Lead Sponsor:
Woodlands Health Campus
Collaborating Sponsors:
Tan Tock Seng Hospital
Conditions:
Type 2 Diabetes Treated With Insulin
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
This is a pilot study of the use of flash glucose monitoring (FGM) to assess glycemic control, behavioural, quality of life benefits and manpower utilization in poorly controlled T2DM patients on insu...
Detailed Description
Background: Hospitalization often provides an opportunity to optimise the care of patients with diabetes, however, there could be destabilisation of dietary habits and diabetes therapy during admissi...
Eligibility Criteria
Inclusion
- Age between 21-80 inclusive
- HbA1c\>9% on insulin
- Requiring inpatient adjustment of DM medication if meets any of the following:
- A) Hypoglycemia (defined as glucose \< 4 mmol/l occurring 2 or more times at least 3 hours apart in the last 72 hours or any glucose \<2.5 mmol/l in the last 24 hours)
- B) Hyperglycemia (defined as glucose \> 14 mmol/l occurring 2 or more times in the last 36 hours, or any glucose \> 24 mmol/l in the last 24 hours)
- Desire to lower HbA1c to a target of 7%
- Willing to wear FGM device
- Willing and able to use FreeStyle Librelink app on personal device
- Willing to avoid use of ascorbic acid throughout the study
- Willing to perform SMBG (by history) of an average of at least 4 times a day, 3 days a week
Exclusion
- T1DM
- Pregnant or planning pregnancy during duration of study
- Unable to use or unwilling to comply with study requirements
- Use of personal FGM within 3 months of screening or plan to use personal FGM during the course of the study
- On ascorbic acid
- Extensive skin changes that preclude wearing the sensor on normal skin (e.g. extensive psoriasis, extensive eczema, recent burns or severe sunburn, extensive tattoos, dermatitis herpetiformis)
- Known allergy to medical-grade adhesives
- Renal insufficiency (eGFR\<30)
- Pancreatic insufficiency or history of pancreatitis
- Patients on any structured weight reduction interventions such as prescription weight loss medications, bariatric surgery, or protein sparing modified fast during the course of the study.
- Current or anticipated short term uses of glucocorticoids (oral, injectable, or intravenous. Long-term stable glucocorticoid doses are allowed, such as for treatment of rheumatoid arthritis or Addison's disease.
- Any medical condition that would make it inappropriate to target an HbA1c of \<7%
- Currently abusing illicit drugs, alcohol or prescription drugs
- Any condition per investigator assessment, that could impact reliability of the HbA1c measurement, such as but not limited to hemoglobinopathy, haemolytic anaemia, chronic liver disease, chronic GI blood loss, recent red blood cell transfusion or erythropoietin administration within 3 months prior to screening
- Current participation in another investigational study (must have completed any prior studies at least 30 days prior to being enrolled in this study)
Key Trial Info
Start Date :
November 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04871438
Start Date
November 10 2021
End Date
September 30 2022
Last Update
July 14 2022
Active Locations (1)
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1
Tan Tock Seng Hospital
Singapore, Singapore