The Effects of CGM and Connected Pen in T2DM Treated With Multiple Daily Insulin Injections

NCT06311019 | Active Not Recruiting DMC

• 1 other identifier: 791572
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 5

Brief Summary

The aim of the study is to evaluate the effect of a combination of 12 months treatment with CGM (Freestyle Libre 2) with hypo and hyper alert in combination with a smart pen for bolus insulin (NOVOpen6) on HbA1c and time in range (TIR) in T2DM patients with baseline HbA1c \>53 mmol/mol (7. 0%, eAG 8,6 mmol/l) as compared with standard care.

Conditions

Type 2 Diabetes Treated With Insulin

Keywords

Type 2 diabetes mellitus; Insulin; Continuous glucose monitoring; Connected Pen

Outcome Measures

Primary Outcomes (1)

• Change in Haemoglobin A1c

  Change between groups in Haemoglobin A1c (mmol/mol) from baseline to follow-up A prespecified exploratory analysis is planned for: male vs. female age \< 65 year vs. age ≥ 65 year baseline HbA1c \< 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for \> 2 meals Number of average views by Libre 2 for the last month \< 10 vs. per day vs. ≥10 scannings. A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days.

  Baseline and follow-up after 12 months

Secondary Outcomes (9)

• Change Time in range

  Baseline and follow-up after 12 months

• Change in Time above range

  Baseline and follow-up after 12 months

• Change in Time below range

  Baseline and follow-up after 12 months

• Mean glucose

  Baseline and follow-up after 12 months

• Standard deviation

  Baseline and follow-up after 12 months

Other Outcomes (9)

• Fingerprick glucose measurement

  Baseline and follow-up after 12 months

• Glucose views on mobile phone

  Follow-up at 12 months

• Use of Novopen 6 memory function

  Follow-up at 12 months

Study Arms (2)

1 (Standard care)

NO INTERVENTION

In this arm the patients continue to measure blood glucose with fingerprick and use standard insulin pens

2 (CGM and connected pen)

ACTIVE COMPARATOR

In this arm the patients switch from glucose measurement with fingerprick to continuous glucose monitoring and they switch from standard insulin pen for bolusinsulin to connected pen for bolusinsulin

Device: Continuous glucose monitoring and use of connected insulinpen for bolus insulin

Interventions

Continuous glucose monitoring and use of connected insulinpen for bolus insulin DEVICE

Continuous glucose monitoring (Abbott Freestyle Libre 2) and use of connected insulinpen (Novopen 6) for bolus insulin

2 (CGM and connected pen)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Type 2 DM.
• \- HbA1c \> 53 mmol/l (7.0 %, estimated average glucose (eAG) 8.6 mmol/l).
• \- Contact to diabetes clinic for ≥ 6 months.
• \- Insulin treatment ≥ 12 months.
• \- Basal insulin and bolus insulin at least for one meal every day.
• \- Bolus insulin is insulin aspart.
• \- Stable insulin treatment (change 10 % or less) and no introduction of other antihyperglycemic agents (oral or GLP1 analogue) for at least 2 months before randomization.
• \- Considered to be technically and intellectually capable of using isCGM and smart pen.
• \- Can communicate in Danish.
• \- Informed consent including acceptance to share glucose data from the Libreview platforms.
• \- The patient has a smart phone suitable for Libre and NOVOpen6 data registration.

You may not qualify if:

• \- Individual goal for HbA1c is reached (even if \> 53 mmol/mol), i.e. relaxed treatment goals as relevant for fragile patients with severe diabetic complications or comorbidities.
• \- Fasting C-peptide \< 370 pmol/l.
• \- Actual treatment with CGM or previous use of CGM for more than four weeks or \< 6 months before recruitment. No actual or previous use of connected pen.
• \- One or more severe hypoglycemic episode (assistance of third party) within the previous 12 months.
• \- Considered unable to participate due to frequent cancellation of appointments.
• \- Ongoing steroid treatment or expected intermittent treatment of more than 14 days' duration.
• \- Pregnant or planning pregnancy.
• \- Participating in other trials.
• \- Clinical conditions interfering with interpretation of HbA1c (phlebectomy, bleeding or haemolytic disorders, erythropoietin treatment, known haemoglobin variants, etc.) or continuous intake of high dose of vitamin C (\> 1000 mg), salicylic acid (650 mg daily), Salazopyrin or Dapsone.
• \- Allergic reaction to the adhesive used in the isCGM.

Sponsors & Collaborators

• Klavs Würgler Hansen: lead
• Steno Diabetes Center Aarhus, Denmark: collaborator

Study Sites (5)

Steno Diabetes Center Aarhus

Aarhus, 8000, Denmark

Location

Gødstrup Regional Hospital

Herning, 7400, Denmark

Location

Horsens Regional Hospital

Horsens, 8700, Denmark

Location

Randers Regional Hospital

Randers, 8900, Denmark

Location

Regional Hospital Silkeborg, Central Jutland Hospital

Silkeborg, 8600, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Klavs W Hansen

  Medical Diagnostic Center, Silkeborg Regional Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: March 15, 2024
• Study Start: February 27, 2024
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 2026
• Access Criteria: on reasonable request

Locations

DK (5)