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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes Treated With Insulin
• Intervention / Treatment: Device: Flash glucose monitoring

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 admission. During transition from hospital to home, diabetes treatment may be intensified to control hyperglycemia, such as starting insulin therapy, or, de-escalated, due to risks of hypoglycaemia secondary to variable oral intake and physical activity levels peri-hospitalization.

Achieving optimal glycemic control necessitates frequent blood glucose monitoring. However, patients may perceive repeated self-monitoring of blood glucose (SMBG) as inconvenient, intrusive and laborious as it requires pricking their fingers multiple times, resulting in reduced compliance and poorer glycemic outcomes. Ambulatory flash glucose monitoring (FGM) may overcome this and facilitate more rapid achievement of euglycemia due to the benefit of immediate feedback of glucose levels with changes in diet, medication and activity.

As the transitional care period is a period of stress for patients and an opportunity to encourage behavioural change, we propose that the use of intermittent short term FGM in the first two weeks post discharge, and for another two weeks at a 6-week interval may promote behavioural change resulting in improvements in glycemic control.

Objectives:

1. To explore the use of FGM in patients with T2DM with baseline HbA1c >9% and requiring insulin who at risk of hypoglycemia or hyperglycemia, in facilitating the transition care from inpatient to the ambulatory setting.
2. This pilot study is exploratory to determine the logistics and feasibility of the protocol, and to collect preliminary information that will lead to a larger grant application for a larger clinical trial in the future.

Hypotheses:

1. FGM use in patients with T2DM with baseline HbA1c >9% and requiring insulin would facilitate the transition of care from inpatient to the ambulatory setting, resulting in improved glycemic control, as measured by HbA1c at 12 weeks.
2. FGM use in the transitional care period would lead to improved time in range (TIR), reduced time in hypoglycaemia and hyperglycaemia, reduced readmission rates for hypo or hyperglycaemia, improved quality of life, reduced loss to follow-up and encourage individual lifestyle modification, without a significant increase in costs and manpower utilization.

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caroline WS Hoong; Phone Number: +65 63573737; Email: caroline_hoong@whc.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • Tan Tock Seng Hospital
    • Contact: Caroline WS Hoong; Phone Number: +65 63573735
    • Principal Investigator: Daniel EK Chew

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FGM; Flash glucose monitoring at weeks 0-2, weeks 6-8 post-discharge	Device: Flash glucose monitoring; 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.; Other Names: Abbott FreeStyle Libre
No Intervention: SMBG; Self-monitoring of blood glucose at least 4 times a day, 3 days a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Assess change in glycaemic control between groups	6 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% Time in range, % Time below range, % Time above range	Glucose in-range defined as 3.9-10.0mmol/l, below range = glucose <3.9mmol/l, above range = glucose >10.0mmol/l	12 weeks
Glycaemic variability	Defined by SD and CV	12 weeks
Severe hypoglycemia events	Defined by number of hypoglycemic events requiring 3rd party to rescue	12 weeks
Resource utilization	Defined as time used for telehealth and clinic consults	12 weeks
Number of re-admissions for dysglycemia or device-related complications	Within duration of study	12 weeks
Diabetes Distress Scale (DDS)	This 17-item scale lists potential problem areas that people with diabetes may experience, and can denote the degree to which they are or are not affected. Min-Max score of 1-6, where higher score indicates more distress.	12 weeks
Audit of Diabetes-Dependent Quality-of-Life Questionnaire (ADDQoL)	This questionnaire assesses the impact of diabetes on 19 life domains including physical functioning, symptoms, psychological well-being, social well-being, role activities and personal constructs, and allows them to indicate the importance of these domains to their quality of life. Average weighted impact score Min to Max -9 to +3, where a lower score indicates poorer quality of life.	12 weeks
Glucose Monitoring Satisfaction Score (GMSS)	This 15-item scale evaluates patient satisfaction with their glucose monitoring device and its impact on their quality of life including 4 sub-sections on openness, emotional burden, behavioural burden and worthwhileness. Min-max score of 1-5, where a higher score indicates greater satisfaction.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean glucose	Mean glucose	12 weeks
Dietary intake	measured in kcal/day	12 weeks
Exercise duration	measured in minutes/week	12 weeks

Collaborators and Investigators

• Sponsor: Woodlands Health Campus
• Collaborators: Tan Tock Seng Hospital
• Investigators: Principal Investigator: Caroline WS Hoong, Woodlands Health Campus

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2021
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Transitional care; FreeStyle Libre; Flash continuous glucose monitoring
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DSRB 2020/01468

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No