An interventional study of Continuous glucose monitoring and use of connected insulinpen for bolus insulin in Type 2 Diabetes Treated With Insulin, sponsored by Klavs Würgler Hansen. Active, not recruiting at 5 sites in Denmark. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-07.
Sponsored by Klavs Würgler Hansen · Not applicable, Interventional, and Treatment
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.
This study is a 12 months open-label randomized controlled trial.
Subjects with basal/bolus insulin treated T2DM and HbA1c >53 mmol/mol are randomized to:
A (control): standard care with disposable insulin pens and fingerprick glucose measurement or B (intervention): Novopen6 for bolus insulin and glucose measurement with Freestyle Libre 2.
Due to the nature of the treatments it is not possible to perform a blinded study.
Randomization in ratio 1:1 will be formed electronically in a REDCap database.
The investigators estimate that the mean HbA1c at baseline is 60 mmol/mol. Given a standard deviation of the difference of approximately 8.1 mmol/mol (based on in house data from 114 patients with T2DM and insulin), the investigators calculate that 47 patients are needed in each arm to detect a minimal relevant difference of 5 mmol/mol with a type I error of 5% and a type II error 15%. Allowing for 10 % dropouts, the investigators aim to recruit 52 patients in each arm. If an interim analysis 3 months after randomizing 40 patients suggest a higher drop-out rate, the study size will be increased accordingly to a drop-out rate of max. 20 % (56 in each arm).
Study plan
Pre-screening of eligible patients was performed by assessing data from the healthcare administrative electronic software platform Business Intelligence (BI) of the Central Denmark Region. In this portal, data on medication, lab results, time period for contact to outpatient clinic for persons followed in secondary healthcare are automatically registered by data capture. Data can be retrieved from the BI portal via access to an encrypted version of the civil registration numbers allocated to all Danish citizens. The investigators collected data on prescribed pharmacological treatment for all persons with Type 2 diabetes who have had a minimum of one contact to the study centers.
The electronic patient records for potential study candidates were reviewed for in- and exclusion criteria. Patients still considered study candidates after pre-screening were contacted by e-mail and invited to a meeting.
Visit 1 (- 4 weeks): Inclusion and exclusion criteria are reviewed. Orally information of the study plan provided with reflection-time up to 24 hours. Planning fasting blood sample, blinded CGM (Freestyle Libre Pro) is applied, medication reviewed. Questionnaires answered.
Visit 2 (-2 weeks): Fasting blood samples, Libre Pro removed and uploaded.
Visit 3 (0 months): Randomization if inclusion criteria are full-filled and no exclusion criteria. Otherwise considered a screening failure. Randomization to either:
A (control): continues treatment with usual insulin pens and self measurements of blood glucose.
B (intervention): changes to NovoPen 6 for bolus insulin and CGM (Abbott Freestyle Libre 2). Patients randomized to intervention will participate in a structured education programme about the clinical use of Libre 2 and Novopen 6. This also includes assistance to upload LibreLink app. on the mobile phone, to upload Novopen 6 data and to establish a Libre View account. The patients fill in the diabetes health related questionnaires.
Visit 4 Intervention group only (1 month): Telephone call (by study nurse) or optional personal meeting as necessary. Technical support only as needed for the upload of Freestyle Libre 2 and Novopen6 to LibreView.
Visit 5 (11½ months): Blinded Freestyle Libre Pro is applied to all subjects (arm A and B).
Visit 6 (12 months): Blood sample for HbA1c. Discontinuation and upload of Freestyle Libre Pro IQ (Libre view) and blood glucose-meter (Glooko)) for the last 14 days for both the control and intervention arm. In addition upload of Libre 2 and Novopen6 data (Libre view) for the last 4 weeks is performed for the intervention arm. Fill in of diabetes health related questionnaires and use of the memory function of Novopen 6
In-between study visits patients follow standard care in terms of number of visits (physical or telemedicine), type of health care provider (nurse or doctor), measurement of HbA1c and other clinical activities at the health care providers discretion, to enhance extern validity.
The glucose data is evaluated by the usual health care providers together with the patient in order to optimize insulin therapy, including an increase in the number of meals with bolus insulin if necessary.
According to the study design all patients are treated with bolus insulin for at least one meal. Bolus insulin should be insulin aspart. If patients are treated with insulin aspart manufactured by other companies than Novo Nordisk, the patients are asked to change to the biosimilar product from Novo. This strategy ensures that all patients can undergo randomization, since only Novo products fits into the Novopen6. Fast acting insulin is provided to all the patients in the study period free of charge. Patients randomized to the intervention group B receives Novopen6 free of charge.
Patients are included irrespective of the brand of basal insulin. Any other glucose lowering drug (oral or injection) can be added or discontinued during the study at the investigators discretion.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 104 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Klavs Würgler Hansen is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this arm the patients continue to measure blood glucose with fingerprick and use standard insulin pens
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
Continuous glucose monitoring (Abbott Freestyle Libre 2) and use of connected insulinpen (Novopen 6) for bolus insulin
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.
Time frame: Baseline and follow-up after 12 months
Change Time in range
Change in the fraction (%) of glucose values in the range 3.9 to 10.0 mmol/l, measured by Libre Pro IQ for 14 days. 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.
Time frame: Baseline and follow-up after 12 months
Change in Time above range
Change in The fraction (%) of glucose values in the range \> 10.0 mmol/l, measured by Libre Pro IQ for 14 days. 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.
Time frame: Baseline and follow-up after 12 months
Change in Time below range
Change in the fraction (%) of glucose values \< 3.9 mmol/l, measured by Libre Pro IQ for 14 days. 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.
Time frame: Baseline and follow-up after 12 months
Mean glucose
The mean of all glucose values for 14 days measured by Libre Pro IQ. 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.
Time frame: Baseline and follow-up after 12 months
Standard deviation
The standard deviation of glucose values for 14 days, measured by Libre Pro IQ. 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.
Time frame: Baseline and follow-up after 12 months
Change in CV
Change in the coefficient of variation (%) for glucose values for 14 days, measured by Libre Pro IQ for 14 days. 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.
Time frame: Baseline and follow-up after 12 months
Change in Time with rapid glucose change
Change in the time fraction (%) with glucose rate of change \> 1.5 mmol/l/15 min, measured by Libre Pro. 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. IQ for 14 days.
Time frame: Baseline and follow-up after 12 months
Change in ARRC
Change in Mean of average absolute change of glucose rate (ml/mol/15 min), measured by Libre Pro IQ for 14 days. 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.
Time frame: Baseline and follow-up after 12 months
Fraction of patients with increased number of bolus insulin per day
The fraction of patients increasing from one or two meals with bolus insulin to two or three meals with bolus insulin.
Time frame: Baseline and follow-up after 12 months
Fingerprick glucose measurement
Number of fingerprick glucose measurements for the last 14 days.(fromGlooko download) of BG meters)
Time frame: Baseline and follow-up after 12 months
Glucose views on mobile phone
Numbers of glucose views in the last 14 days in the intervention group (from LibreView).
Time frame: Follow-up at 12 months
Use of Novopen 6 memory function
Self reported numbers of inspections of the insulindose/time on the Novopen 6 cap display for the last 14 days in the intervention group.
Time frame: Follow-up at 12 months
WHO-5
Questionnaire
Time frame: Baseline and follow-up at 12 months
Diabetes Distress Scale
Questionnaire
Time frame: Baseline and follow-up at 12 months
Revised short form of hypoglycaemia Fear Survey
Questionnaire
Time frame: Baseline and follow-up at 12 months
eHealth literacy questionnaire (eHLQ),
Questionnaire
Time frame: Baseline and follow-up at 12 months
The Glucose Monitoring Satisfaction Questionnaire
Questionnaire
Time frame: Baseline and follow-up at 12 months
Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Questionnaire
Time frame: Baseline and follow-up at 12 months
Plan to share: Yes — Data planned to make available: All primary and secondary outcome values
Supporting information: Study protocol, Clinical study report
Time frame: 2026
Access criteria: on reasonable request
No publications or documents are linked to this record.
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Klavs Würgler Hansen