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

NCT ID: NCT04871438

Last Updated: 2022-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-10
• Study Completion Date: 2022-09-30

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:

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.

Conditions

Type 2 Diabetes Treated With Insulin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

FGM

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

Group Type: EXPERIMENTAL

Flash glucose monitoring

Intervention Type: 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.

SMBG

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Abbott FreeStyle Libre

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tan Tock Seng Hospital

OTHER

Sponsor Role: collaborator

Woodlands Health Campus

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline WS Hoong

Role: PRINCIPAL_INVESTIGATOR

Woodlands Health Campus

Locations

Tan Tock Seng Hospital

Singapore, , Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Caroline WS Hoong

Role: CONTACT

caroline_hoong@whc.sg

+65 63573737

Facility Contacts

Caroline WS Hoong

Role: primary

+65 63573735

References

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.

Reference Type: BACKGROUND

PMID: 26246779 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28346946 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28290224 (View on PubMed)

Other Identifiers

DSRB 2020/01468

Identifier Type: -

Identifier Source: org_study_id