NCT04331444

Brief Summary

The overall objective of this research study is to examine the effectiveness of the use of CGM vs. SMBG in persons with insulin-treated type 2 diabetes on glycemic variables and patient reported outcomes on treatment satisfaction, health behavior and wellbeing. The independent effect of peer-support will also be studied.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

2.9 years

First QC Date

March 26, 2020

Last Update Submit

October 11, 2023

Conditions

Type 2 Diabetes Treated With Insulin

Keywords

Type 2 diabetesContinuous glucose monitoringInsulin-treatedRCT

Outcome Measures

Primary Outcomes (1)

  • Difference between change in TIR (3.9-10 mmol/l) in percent, assessed via blinded CGM device, between CGM group (A) and SMBG group (C)

    Percent

    from baseline to 12 months

Secondary Outcomes (40)

  • Difference between change in HbA1c between the CGM group (A) and the SMBG group (C)

    from baseline to 12 months

  • Difference between change in mean sensor glucose concentration measured by 2 weeks blinded CGM between the CGM group (A) and the SMBG group (C)

    from baseline to 12 months

  • Difference between change in time below range (TBR) (< 3.9 mmol/l, < 3.0 mmol/l), in percent, measured by 2 weeks blinded CGM between the CGM group (A) and the SMBG group (C)

    from baseline to 12 months

  • Difference between change in time above range (TAR) (>10 mmol/l, > 13.9 mmol/l), in percent, measured by 2 weeks blinded CGM, between the CGM group (A) and the SMBG group (C)

    from baseline to 12 months

  • Difference between change in glycemic variability (SD, Coefficient of variance and others), measured by 2 weeks blinded CGM between the CGM group (A) and the SMBG group (C)

    from baseline to 12 months

  • +35 more secondary outcomes

Other Outcomes (1)

  • Evaluating which blood glucose measured by SMBG best reflect TIR

    from baseline to 12 months

Study Arms (3)

Group A, CGM

EXPERIMENTAL

Addition of a calibration free real-time CGM in 12 months in persons with type 2 diabetes treated with insulin. The participants will participate in a training course that will include the influence of different food items and exercise on glucose levels, how to measure SMBG correctly. Furthermore, participants in group A (intervention) will, in similarity to the HCPs, receive a CGM-education and training session led by the study investigator and will be interactive and hands-on, using case studies. The training session will include spoken and written instructions on how to insert and wear the CGM device and how to interpret the CGM information to better understand the relation between participants blood glucose and their diabetes self-management.

Device: CGMBehavioral: training course

Group B, CGM + peer-support

EXPERIMENTAL

Addition of a calibration free real-time CGM in 12 months in persons with type 2 diabetes treated with insulin plus 3 sessions of peer-support in groups of 6 participants. The participants will participate in a training course that will include the influence of different food items and exercise on glucose levels, how to measure SMBG correctly. Furthermore, participants in group B (intervention incl. peer-support) will, in similarity to group A, receive a CGM-education and training session. The training and CGM-course for participants in group B are similar to the course for group A with the addition of three peer-support sessions. The approach will be participatory and adaptable to allow flexibility in the content of the peer-support sessions and involving customized use of participatory methods i.e. dialogue tools and exercises.

Device: CGMBehavioral: training courseBehavioral: Peer-support

Group C, SMBG

ACTIVE COMPARATOR

Standard self-monitoring of blood glucose according to standard guidelines, in 12 months. The participants will participate in a training course that will include the influence of different food items and exercise on glucose levels, how to measure SMBG correctly.

Behavioral: training course

Interventions

CGMDEVICE

Using the CGM during the entire study period of 12 months.

Also known as: Continuous glucose monitoring
Group A, CGMGroup B, CGM + peer-support
training courseBEHAVIORAL

The participants in the three groups will attend a three-hour training course with different content depending on the group allocation. The aim of this training course is to ensure that the participants have the knowledge, support and confidence to work collaboratively with their HCPs to increase TIR and decrease HbA1c.

Group A, CGMGroup B, CGM + peer-supportGroup C, SMBG
Peer-supportBEHAVIORAL

The peer-support will be facilitator-led by the primary investigator with peer exchange in group sessions (3 sessions over the study period, 3 hours per session) with 6-8 participants in every group.

Also known as: Group sessions
Group B, CGM + peer-support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes according to clinical definitions
  • Treated with insulin injections at least once daily on top of diet and exercise recommendations. Insulin therapy has been used for at least 12 months. Can be additionally treated with one or more different oral antidiabetic drugs (except sulfonylurea), and/or glucagon-like-peptide 1 (GLP-1) analogues
  • Attending the outpatient clinic at Steno Diabetes Center Copenhagen for at least 12 months
  • Age ≥ 18 years
  • HbA1c \> 58 mmol/mol (7.5%) at two consecutively measurements over at least 3 months
  • Willing to use possible interventions; to perform self-monitoring of blood glucose (SMBG) as requested by the investigators AND to use CGM continuously without calibration for a 12-month period.
  • Willing to intensify non-medical and medical treatment to achieve better glucose control.

You may not qualify if:

  • Inability to understand the patient information and give informed consent
  • Not speaking and understanding Danish
  • Treatment with sulfonylurea (SU) during the last 3 months before study start
  • New antidiabetic treatment the last three months
  • Use of systematic corticosteroids
  • Visual impairment
  • Severe skin allergy for adhesive tape to the patch of CGM or other skin condition that inhibits the use of a CGM device
  • Comorbidity which does not allow lowering of HbA1c to 53 mmol/mol (7.0%)
  • Hypoglycemic unawareness
  • Impaired renal disease with eGFR \< 45 ml/min/1.73m2
  • Conditions that impact the stability of a HbA1c measurement (chronic liver disease, haemoglobinopathy, anemia etc.)
  • Known or suspected alcohol or drug abuse
  • Already using Flash glucose monitoring (Libre) or CGM
  • Enrolled in another clinical study
  • Pregnancy, intend to become pregnant, breastfeeding or not using adequate contraceptive methods

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center Copenhagen

Gentofte Municipality, Capital Region, 2820, Denmark

Location

Related Publications (1)

  • Lind N, Lindqvist Hansen D, Saetre Rasmussen S, Norgaard K. Real-time continuous glucose monitoring versus self-monitoring of blood glucose in adults with insulin-treated type 2 diabetes: a protocol for a randomised controlled single-centre trial. BMJ Open. 2021 Jan 15;11(1):e040648. doi: 10.1136/bmjopen-2020-040648.

    PMID: 33452188DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Study Officials

  • Nanna Lind, RN MSc

    Steno Diabetes Center Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, MSc. in nursing

Study Record Dates

First Submitted

March 26, 2020

First Posted

April 2, 2020

Study Start

August 1, 2020

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

October 12, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Study results, positive, negative and inconclusive findings, will be presented at national and international scientific meetings and published in at least three scientific papers in international scientific peer-reviewed journals and through the PhD thesis. After conclusion of the study, a final report will be generated and sent to the Regional Scientific Ethics Committee (RVK). The study protocol will furthermore be published at www.clinicaltrial.gov.

Locations

DK(1)