Flash CONtinous Glucose Monitoring in TRansition to Outpatient: Libre for Type 2 Diabetes Mellitus (CONTROL-DM)

NCT04871438 | Unknown DMC

• 1 other identifier: DSRB 2020/01468
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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 insulin in the transitional care period after discharge from hospital.

Conditions

Type 2 Diabetes Treated With Insulin

Keywords

Flash continuous glucose monitoring; Transitional care; FreeStyle Libre

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Assess change in glycaemic control between groups

  6 weeks, 12 weeks

Secondary Outcomes (8)

• % Time in range, % Time below range, % Time above range

  12 weeks

• Glycaemic variability

  12 weeks

• Severe hypoglycemia events

  12 weeks

• Resource utilization

  12 weeks

• Number of re-admissions for dysglycemia or device-related complications

  12 weeks

Other Outcomes (3)

• Mean glucose

  12 weeks

• Dietary intake

  12 weeks

• Exercise duration

  12 weeks

Study Arms (2)

FGM

EXPERIMENTAL

Flash glucose monitoring at weeks 0-2, weeks 6-8 post-discharge

Device: Flash glucose monitoring

SMBG

NO INTERVENTION

Self-monitoring of blood glucose at least 4 times a day, 3 days a week

Interventions

Flash glucose monitoring DEVICE

Group A will use FreeStyle Libre for two weeks of FGM-based titration of medications at two time-points: 1) At recruitment and 2) At 6 weeks. Outside of these time points, they will use SMBG (standard care) for monitoring of blood glucose.

Also known as: Abbott FreeStyle Libre

FGM

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Woodlands Health Campus: lead
• Tan Tock Seng Hospital: collaborator

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore

RECRUITING

Related Publications (3)

• Hirschman KB, Bixby MB. Transitions in Care from the Hospital to Home for Patients With Diabetes. Diabetes Spectr. 2014 Aug;27(3):192-5. doi: 10.2337/diaspect.27.3.192.

  PMID: 26246779 BACKGROUND

• Rushakoff RJ, Sullivan MM, MacMaster HW, Shah AD, Rajkomar A, Glidden DV, Kohn MA. Association Between a Virtual Glucose Management Service and Glycemic Control in Hospitalized Adult Patients: An Observational Study. Ann Intern Med. 2017 May 2;166(9):621-627. doi: 10.7326/M16-1413. Epub 2017 Mar 28.

  PMID: 28346946 BACKGROUND

• Levitt DL, Silver KD, Spanakis EK. Inpatient Continuous Glucose Monitoring and Glycemic Outcomes. J Diabetes Sci Technol. 2017 Sep;11(5):1028-1035. doi: 10.1177/1932296817698499. Epub 2017 Mar 14.

  PMID: 28290224 BACKGROUND

Study Officials

• Caroline WS Hoong

  Woodlands Health Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline WS Hoong

CONTACT

+65 63573737; caroline_hoong@whc.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: May 4, 2021
• Study Start: November 10, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)