AzTrials
AzTrials

Diabetes Mellitus, Type 1CONNECT 1NCT05069545

A Research Study Looking at How the Use of NovoPen® 6 for Treatment With Tresiba® & Fiasp® Affects the Blood Sugar Level in Patients With Type 1 Diabetes as Part of Local Clinical Practice

An observational study of Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 26 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to collect information on how NovoPen® 6 works with Tresiba® \& Fiasp® for treatment of people with type 1 diabetes and see if the use of NovoPen® 6 can help participants achieve better blood sugar levels. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Insulin degludec and Fast-acting insulin aspart
How many people
411 participants
Where
26 sitesin 4 countries
Study dates
11 Oct 2021to 10 Sep 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants will use Tresiba® and Fiasp® in NovoPen® 6 as prescribed to participants by the study doctor

Who may be able to join

  • Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
  • Male or female, age above or equal to 18 years at the time of signing consent.
  • Diagnosed with T1DM (Type 1 Diabetes Mellitus) for above or equal to 1 year (365 days) at the time of signing consent.
  • On treatment with Tresiba® for more than or equal to 1 month (30 days) and Fiasp® for for more than or equal to 3 months (90 days) at the time of signing consent.
  • The decision to initiate the use of commercially available NovoPen® 6 as a part of treatment with Tresiba® and Fiasp® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
  • Current user of a rtCGM (Real-Time Continuous Glucose Monitoring) or isCGM (Intermittent-scanning Continuous Glucose Monitoring) for greather than or equal to 2 months (60 days) of which the last 14 days must be on rtCGM or isCGM, which can integrate the data with diabetes treatment support solution from either Glooko or Abbott, at the time of signing consent.
  • Willingness to continue using a rtCGM or isCGM for the duration of the study, which can integrate the data with diabetes treatment support solution from either Glooko or Abbott.
  • Current user of a diabetes treatment support solution from either Glooko or Abbott, which can integrate the NovoPen® 6 injection data and the rtCGM/isCGM data, and willingness to continue using the same solution for the duration of the study.

Who cannot join

  • Previous participation in this study. Participation is defined as having given consent in this study.
  • Treatment with any investigational drug within 30 days prior to enrolment into the study.
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
  • Use of any smart pen or smart cap for the diabetes treatment prior to the signing consent.

Trial locations and contacts

26 sites in 4 countries.

26 sites in 4 countries

France8 sites

  • Centre Hospitalier Universitaire de Caen Normandie- Cote de Nacre

    Caen, 14033

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, 91106

  • hôpital Saint Joseph Saint Luc

    Lyon, 69365

  • Centre Hospitalier Universitaire de Montpellier-Hopital Lapeyronie

    Montpellier, 34295

  • Ap-Hp-Hopital Bichat-Claude Bernard-1

    Paris, 75877

  • Hospices Civils de Lyon-Hopital Lyon Sud-2

    Pierre-Bénite, 69495

  • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2

    Toulouse, 31054

  • Chru de Nancy - Hopital Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Sweden8 sites

  • Diabetesmottagningen, Medicinkliniken, Södra Älvsborgs Sjukhus

    Borås, 501 82

  • Diabetesmottagningen, Södra Älvsborgs Sjukhus

    Borås, 501 82

  • Endokrinologiska kliniken, Malmö

    Malmö, 205 02

  • Medicinmottagning1 Universitetssjukhuset Örebro

    Örebro, 701 85

  • Centrum for Diabetes, Academical Specialist Centrum

    Stockholm, 113 65

  • Medicinkliniken Sundsv

    Sundsvall, 851 86

  • Uppsala universitetssjukhus

    Uppsala, 751 85

  • Frölunda Specialistsjukhus

    Västra Frölunda, 42144

Other trials in Sweden

Belgium6 sites

  • Imeldaziekenhuis - Bonheiden - Department of Endocrinology

    Bonheiden, 2820

  • HUB - Hôpital Erasme

    Brussels, 1070

  • Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie

    Brussels, 1200

  • UZA - UZ Antwerpen - Department of Endocrinology

    Edegem, 2650

  • UZ Leuven - Endocrinology

    Leuven, 3000

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000

Other trials in Belgium

Denmark4 sites

  • Aarhus Universitetshospital Diabetes og Hormonsygdomme

    Aarhus N, 8200

  • Bispebjerg Hospital, IC-Forskning

    Copenhagen, 2400

  • Medicinsk Afdeling B, Herning Centralsygehus

    Herning, 7400

  • Regionshospitalet Silkeborg - Endokrinologisk afd.

    Silkeborg, 8600

Other trials in Denmark

About this study

Official title: A Multi-centre Prospective Non-interventional Clinical Investigation Studying the Glycaemic Control in Patients With Type 1 Diabetes When Introducing a NovoPen® 6 for Treatment With Tresiba® (Insulin Degludec) & Fiasp® (Fast-acting Insulin Aspart) in a Real-world Setting

The purpose of this study is to collect information on how NovoPen® 6 works with Tresiba® \& Fiasp® for treatment of people with type 1 diabetes and see if the use of NovoPen® 6 can help participants achieve better blood sugar levels.

Participants will use Tresiba® \& Fiasp® in NovoPen® 6 as prescribed to participants by the study doctor.

Read more

NovoPen® 6 is a smart pen, which collects and stores the date and time of injections and number of units of insulin participants have taken.

NovoPen® 6 can transfer participants insulin dosing information to the mobile application, which participants use to see their continuous blood sugar level. This will allow participants to see their insulin doses along with continuous blood sugar level in the mobile application.

Participants will keep using their own continuous blood sugar monitoring device and the mobile application to see these data during the study.

The study will last for about 9-11 months. Participants will be asked to complete 2 questionnaires in this study. One questionnaire is about overall satisfaction of using a digital health solution and other is about quality of life. Participants will complete these questionnaires during their normally scheduled visit with the study doctor, on 2 separate occasions

Being tested
Insulin degludec, Fast-acting insulin aspart
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin degludecDrug

    Introducing a NovoPen® 6 to patients with type 1 diabetes mellitus (T1DM), who are already being treated with Tresiba® and Fiasp®

  • Fast-acting insulin aspartDrug

    Introducing a NovoPen® 6 to patients with type 1 diabetes mellitus (T1DM), who are already being treated with Tresiba® and Fiasp®

Study groups in NCT05069545
Study groupRoleWhat they receive
Tresiba + Fiasp using NovoPen 6 per local labelParticipants will use Tresiba® and Fiasp® in NovoPen® 6 as prescribed to participants by the study doctor
Receives: Drug: Insulin degludec; Drug: Fast-acting insulin aspart

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in time in range (3.9-10 mmol/L)

    Percentage change (absolute)

    (Using available rtCGM (Real-Time Continuous Glucose Monitoring) and isCGM data(Intermittent-scanning Continuous Glucose Monitoring))

    Measured: Baseline (Day -14 to Day 0) to End of Study (Day 280)

Secondary outcomes (11)

  1. Change in time in hyperglycaemia/above range Level 1 (10.1 - 13.9 mmol/L)

    Percentage change (absolute)

    (Using available rtCGM and isCGM data)

    Measured: Baseline (Day -14 to Day 0) to End of Study (Day 280)

  2. Change in time in hyperglycaemia/above range Level 2 (greater than 13.9 mmol/L)

    Percentage change (absolute)

    (Using available rtCGM and isCGM data)

    Measured: Baseline (Day -14 to Day 0) to End of Study (Day 280)

  3. Change in time in hypoglycaemia/below range Level 1 (3.0-3.8 mmol/L)

    Percentage change (absolute)

    (Using available rtCGM and isCGM data)

    Measured: Baseline (Day -14 to Day 0) to End of Study (Day 280)

  4. Change in time in hypoglycaemia/below range Level 2 (below 3.0 mmol/L)

    Percentage change (absolute)

    (Using available rtCGM and isCGM data)

    Measured: Baseline (Day -14 to Day 0) to End of Study (Day 280)

  5. Change in mean glucose

    mmol/L (Using available rtCGM and isCGM data)

    Measured: Baseline (Day -14 to Day 0) to End of Study (Day 280)

  6. Change in glucose variability (% coefficient of variability)

    Percentage change (absolute)

    (Using available rtCGM and isCGM data)

    Measured: Baseline (Day -14 to Day 0) to End of Study (Day 280)

  7. Change in Glucose Management Indicator

    Percentage change (absolute)

    (Using available rtCGM and isCGM data) (4The GMI is calculated from mean glucose as GMI (%) = 3.31 + 0.4306 [mean glucose mmol/L])

    Measured: Baseline (Day -14 to Day 0) to End of Study (Day 280)

  8. Change in HbA1c (Glycated haemoglobin)

    Percentage change (absolute) (Using HbA1c results based on blood tests)

    Measured: Baseline (Week 0) to End of Study (Week 40)

  9. T1-DDS (Diabetes Distress Scale for Adults with Type1 Diabetes), change in QoL (Quality of Life)

    Change (absolute) (Using T1-DDS questionnaire data)

    Measured: Baseline (Week 0) to End of Study (Week 40)

  10. DHSS (Digital Health Solution Satisfaction)-Patient

    Total score (Using DHSS questionnaire for patient \& HCP respectively)

    Measured: End of Study (Week 40)

  11. DHSS-HCP(Health Care Professional)

    Total score (Using DHSS questionnaire for patient \& HCP respectively)

    Measured: End of Study (Week 40)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2021
  2. Study start11 Oct 2021
  3. Primary completion10 Sep 2024
  4. Study completion10 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
411 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05069545
Sponsor's protocol ID
DV3325-4759
Other IDs
U1111-1255-5564
Acronym
CONNECT 1
Status last verified
Dec 2025
First submitted
24 Sep 2021
Last updated
31 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 26 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in France, Sweden, Belgium, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in time in range (3.9-10 mmol/L) (time frame: Baseline (Day -14 to Day 0) to End of Study (Day 280)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05069545.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in