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Type 2 Diabetes Treated With InsulinCONTROL-DMNCT04871438

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

A study testing Flash glucose monitoring in people with Type 2 Diabetes Treated With Insulin, run by Woodlands Hospital at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 80 years
Conditions the study is for
Type 2 Diabetes Treated With Insulin
What is being tested?
Flash glucose monitoring
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteSingapore
Study dates
10 Nov 2021to 30 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%
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  • 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

Who cannot join

  • 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)
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  • 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)

Trial locations and contacts

1 site in 1 country.

Caroline WS Hoong contact

+65 63573737

caroline_hoong@whc.sg

Singapore1 site, 1 recruiting

  • Tan Tock Seng Hospital

    Singapore

    Caroline WS Hoong, +65 63573735

    Daniel EK Chew

    Recruiting

Other trials in Singapore

About this study

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.

Read the 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.
Being tested
Flash glucose monitoring
Keywords
Flash continuous glucose monitoring, Transitional care, FreeStyle Libre

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flash glucose monitoringDevice

    Also called Abbott FreeStyle Libre

    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.

Study groups in NCT04871438
Study groupRoleWhat they receive
FGMExperimentalFlash glucose monitoring at weeks 0-2, weeks 6-8 post-discharge
Receives: Device: Flash glucose monitoring
SMBGNo interventionSelf-monitoring of blood glucose at least 4 times a day, 3 days a week

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

    Assess change in glycaemic control between groups

    Measured: 6 weeks, 12 weeks

Secondary outcomes (8)

  1. % 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

    Measured: 12 weeks

  2. Glycaemic variability

    Defined by SD and CV

    Measured: 12 weeks

  3. Severe hypoglycemia events

    Defined by number of hypoglycemic events requiring 3rd party to rescue

    Measured: 12 weeks

  4. Resource utilization

    Defined as time used for telehealth and clinic consults

    Measured: 12 weeks

  5. Number of re-admissions for dysglycemia or device-related complications

    Within duration of study

    Measured: 12 weeks

  6. 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.

    Measured: 12 weeks

  7. 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.

    Measured: 12 weeks

  8. 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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2021
  2. Study start10 Nov 2021
  3. Primary completion30 Sep 2022 (estimated)
  4. Study completion30 Sep 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04871438
Sponsor's protocol ID
DSRB 2020/01468
Acronym
CONTROL-DM
Status last verified
Jul 2022
First submitted
23 Apr 2021
Last updated
14 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26246779

  • 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.

    PubMed 28346946

  • 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.

    PubMed 28290224

Questions about this trial

What is this clinical trial studying?

A study testing Flash glucose monitoring in people with Type 2 Diabetes Treated With Insulin, run by Woodlands Hospital at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Caroline WS Hoong (+65 63573737, caroline_hoong@whc.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: 6 weeks, 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04871438, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.

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