Comparison of Real-tiMe ContInuous gLucosE moNitoriNg With Self-monitorIng of Blood Glucose in Young AduLts With Type 1 diabeteS

NCT03445377 | Completed DMC

• 1 other identifier: R04778
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to determine whether real-time continuous glucose monitoring (CGM) for 8 weeks is more efficacious compared to self-monitoring of blood glucose (SMBG) in young adults with type 1 diabetes.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Sensor Glucose readings within target range

  Time spent in the target range of 3.9 to 10mmol/l based on sensor glucose levels, throughout the duration of the study periods based on continuous glucose monitoring (CGM).

  8 weeks

Secondary Outcomes (10)

• Sensor Glucose readings below target range

  8 weeks

• Sensor Glucose readings above target range

  8 weeks

• HbA1c at 8 weeks

  8 weeks

• Average variation of glucose levels

  8 weeks

• Standard deviation variation of glucose levels

  8 weeks

Study Arms (2)

Real-time continuous glucose monitoring

ACTIVE COMPARATOR

Subjects will be reviewed and a blood sample will be taken for the measurement of HbA1c. Training on the use of DEXCOM G5 or similar will be provided by the research team. Competency on the use of the system will be evaluated. Participants will be advised to use real-time CGM continuously for the next 8 weeks. At the end of the first intervention, a blood sample for the measurement of HbA1c will be taken. Validated questionnaires evaluating diabetes-related distress, management and user acceptance will be completed.

Device: Real-time continuous glucose monitoring

Self-monitoring of blood glucose

PLACEBO COMPARATOR

Subjects will be reviewed and a blood sample will be taken for the measurement of HbA1c. During the Control Period, masked CGM will be applied for one week, during Week 1, 4 and 8. At the end of this, a blood sample for the measurement of HbA1c will be taken. Validated questionnaires evaluating diabetes-related distress, management and user acceptance will be completed.

Device: Self-monitoring of blood glucose

Interventions

Real-time continuous glucose monitoring DEVICE

Subjects randomised to Real-time continuous glucose monitoring will be given a Dexcom G5 or similar, training on its use, and HbA1c measurements taken at the start and end of the study. They will also be given validated questionnaires to complete.

Real-time continuous glucose monitoring

Self-monitoring of blood glucose DEVICE

Subjects randomised to self monitoring of blood glucose will be given a masked CGM which will be applied for one week, during Week 1, 4 and 8. HbA1c measurements will be taken at the start and end of the study. They will also be given validated questionnaires to complete.

Self-monitoring of blood glucose

Eligibility Criteria

• Age: 16 Years - 297 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 16 - 24 years old (inclusive)
• Type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative
• HbA1c 7.5 - 14.0% based on analysis from local laboratory or equivalent within 1 months of enrolment
• Treated with insulin pump or MDI
• Has a Smart phone compatible with Dexcom G5 or similar
• Willingness to wear study devices
• Willing to follow study specific instructions
• Literate in English

You may not qualify if:

• Non-type 1 diabetes mellitus including those secondary to chronic disease
• Any other physical or psychological disease likely to interfere with the normal conduct of the study
• Untreated celiac disease or hypothyroidism
• Current or planned users of real-time or flash (Libre) glucose monitoring sensors
• Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids, Metformin, SGLT2 inhibitors, GLP-1 agonists, non-selective beta-blockers and MAO inhibitors etc.
• Regular use of acetaminophen
• Medically documented allergy towards the adhesive (glue) of plasters or unable to tolerate tape adhesive in the area of sensor placement
• Serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) located at places of the body, which could potentially be used for localisation of the glucose sensor)
• Lack of reliable telephone facility for contact
• Known or suspected allergy against insulin
• Severe visual impairment
• Severe hearing impairment
• Subject not proficient in English

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• DexCom, Inc.: collaborator

Study Sites (1)

Manchester Diabetes Centre, Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

Related Publications (1)

• Thabit H, Prabhu JN, Mubita W, Fullwood C, Azmi S, Urwin A, Doughty I, Leelarathna L. Use of Factory-Calibrated Real-time Continuous Glucose Monitoring Improves Time in Target and HbA1c in a Multiethnic Cohort of Adolescents and Young Adults With Type 1 Diabetes: The MILLENNIALS Study. Diabetes Care. 2020 Oct;43(10):2537-2543. doi: 10.2337/dc20-0736. Epub 2020 Jul 28.

  PMID: 32723843 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Study Officials

• Hood Thabit, MD

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label, multi-centre, randomised, crossover design study, involving a 2-week run-in period with blinded CGM, followed by two 8 weeks study periods during which subjects will monitor daily glucose levels either with real-time CGM or SMBG in random order.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is an open-label, multi-centre, randomised, crossover design study, involving a 2-week run-in period with blinded CGM, followed by two 8 weeks study periods during which subjects will monitor daily glucose levels either with real-time CGM or SMBG in random order.

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 26, 2018
• Study Start: July 16, 2018
• Primary Completion: June 28, 2020
• Study Completion: June 28, 2020
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 1 year at the end of study
• Access Criteria: Only individuals granted access will be able to view confidential anonymised data from the study.

Locations

GB (1)