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

Primary Purpose

Type 2 Diabetes Treated With Insulin

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Flash glucose monitoring
Sponsored by
Woodlands Health Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes Treated With Insulin focused on measuring Flash continuous glucose monitoring, Transitional care, FreeStyle Libre

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Tan Tock Seng HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

FGM

SMBG

Arm Description

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

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

Outcomes

Primary Outcome Measures

HbA1c
Assess change in glycaemic control between groups

Secondary Outcome Measures

% 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
Glycaemic variability
Defined by SD and CV
Severe hypoglycemia events
Defined by number of hypoglycemic events requiring 3rd party to rescue
Resource utilization
Defined as time used for telehealth and clinic consults
Number of re-admissions for dysglycemia or device-related complications
Within duration of study
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.
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.
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.

Full Information

First Posted
April 23, 2021
Last Updated
July 11, 2022
Sponsor
Woodlands Health Campus
Collaborators
Tan Tock Seng Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04871438
Brief Title
Flash CONtinous Glucose Monitoring in TRansition to Outpatient: Libre for Type 2 Diabetes Mellitus (CONTROL-DM)
Acronym
CONTROL-DM
Official Title
Flash CONtinous Glucose Monitoring in TRansition to Outpatient: Libre for Type 2 Diabetes Mellitus (CONTROL-DM)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Woodlands Health Campus
Collaborators
Tan Tock Seng Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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: 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. 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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Treated With Insulin
Keywords
Flash continuous glucose monitoring, Transitional care, FreeStyle Libre

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FGM
Arm Type
Experimental
Arm Description
Flash glucose monitoring at weeks 0-2, weeks 6-8 post-discharge
Arm Title
SMBG
Arm Type
No Intervention
Arm Description
Self-monitoring of blood glucose at least 4 times a day, 3 days a week
Intervention Type
Device
Intervention Name(s)
Flash glucose monitoring
Other Intervention Name(s)
Abbott FreeStyle Libre
Intervention Description
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.
Primary Outcome Measure Information:
Title
HbA1c
Description
Assess change in glycaemic control between groups
Time Frame
6 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
% Time in range, % Time below range, % Time above range
Description
Glucose in-range defined as 3.9-10.0mmol/l, below range = glucose <3.9mmol/l, above range = glucose >10.0mmol/l
Time Frame
12 weeks
Title
Glycaemic variability
Description
Defined by SD and CV
Time Frame
12 weeks
Title
Severe hypoglycemia events
Description
Defined by number of hypoglycemic events requiring 3rd party to rescue
Time Frame
12 weeks
Title
Resource utilization
Description
Defined as time used for telehealth and clinic consults
Time Frame
12 weeks
Title
Number of re-admissions for dysglycemia or device-related complications
Description
Within duration of study
Time Frame
12 weeks
Title
Diabetes Distress Scale (DDS)
Description
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.
Time Frame
12 weeks
Title
Audit of Diabetes-Dependent Quality-of-Life Questionnaire (ADDQoL)
Description
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.
Time Frame
12 weeks
Title
Glucose Monitoring Satisfaction Score (GMSS)
Description
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.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Mean glucose
Description
Mean glucose
Time Frame
12 weeks
Title
Dietary intake
Description
measured in kcal/day
Time Frame
12 weeks
Title
Exercise duration
Description
measured in minutes/week
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline WS Hoong
Phone
+65 63573737
Email
caroline_hoong@whc.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline WS Hoong
Organizational Affiliation
Woodlands Health Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tan Tock Seng Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline WS Hoong
Phone
+65 63573735
First Name & Middle Initial & Last Name & Degree
Daniel EK Chew

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26246779
Citation
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.
Results Reference
background
PubMed Identifier
28346946
Citation
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.
Results Reference
background
PubMed Identifier
28290224
Citation
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.
Results Reference
background

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

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