Clinical trial NCT05069545: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-10-06
Enrollment: 411
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will use Tresiba® and Fiasp® in NovoPen® 6 as prescribed to participants by the study doctor

Brief 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.

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

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in time in range (3.9-10 mmol/L)
timeFrame: Baseline (Day -14 to Day 0) to End of Study (Day 280)
Secondary outcomes:
measure: Change in time in hyperglycaemia/above range Level 1 (10.1 - 13.9 mmol/L)
timeFrame: Baseline (Day -14 to Day 0) to End of Study (Day 280)
measure: Change in time in hyperglycaemia/above range Level 2 (greater than 13.9 mmol/L)
timeFrame: Baseline (Day -14 to Day 0) to End of Study (Day 280)
measure: Change in time in hypoglycaemia/below range Level 1 (3.0-3.8 mmol/L)
timeFrame: Baseline (Day -14 to Day 0) to End of Study (Day 280)
measure: Change in time in hypoglycaemia/below range Level 2 (below 3.0 mmol/L)
timeFrame: Baseline (Day -14 to Day 0) to End of Study (Day 280)
measure: Change in mean glucose
timeFrame: Baseline (Day -14 to Day 0) to End of Study (Day 280)
measure: Change in glucose variability (% coefficient of variability)
timeFrame: Baseline (Day -14 to Day 0) to End of Study (Day 280)
measure: Change in Glucose Management Indicator
timeFrame: Baseline (Day -14 to Day 0) to End of Study (Day 280)
measure: Change in HbA1c (Glycated haemoglobin)
timeFrame: Baseline (Week 0) to End of Study (Week 40)
measure: T1-DDS (Diabetes Distress Scale for Adults with Type1 Diabetes), change in QoL (Quality of Life)
timeFrame: Baseline (Week 0) to End of Study (Week 40)
measure: DHSS (Digital Health Solution Satisfaction)-Patient
timeFrame: End of Study (Week 40)
measure: DHSS-HCP(Health Care Professional)
timeFrame: End of Study (Week 40)
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis - Bonheiden - Department of Endocrinology
city: Bruxelles
country: Belgium
facility: HUB - Hôpital Erasme
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie
city: Edegem
country: Belgium
facility: UZA - UZ Antwerpen - Department of Endocrinology
city: Leuven
country: Belgium
facility: UZ Leuven - Endocrinology
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital Diabetes og Hormonsygdomme
city: Herning
country: Denmark
facility: Medicinsk Afdeling B, Herning Centralsygehus
city: København
country: Denmark
facility: Bispebjerg Hospital, IC-Forskning
city: Silkeborg
country: Denmark
facility: Endokrinologisk afd, Regions Hospitalet Silkeborg
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen Normandie- Cote de Nacre-1
city: Corbeil Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
city: Lyon
country: France
facility: hôpital Saint Joseph Saint Luc
city: MONTPELLIER cedex 5
country: France
facility: Centre Hospitalier Universitaire de Montpellier-Hopital Lapeyronie
city: Paris
country: France
facility: Ap-Hp-Hopital Bichat-Claude Bernard-1
city: Pierre-Bénite
country: France
facility: Hospices Civils de Lyon-Hopital Lyon Sud-2
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2
city: Vandoeuvre Les Nancy
country: France
facility: Chru de Nancy - Hopital Brabois
city: Borås
country: Sweden
facility: Diabetesmottagningen, Medicinkliniken, Södra Älvsborgs Sjukhus
city: Borås
country: Sweden
facility: Diabetesmottagningen, Södra Älvsborgs Sjukhus
city: Malmö
country: Sweden
facility: Endokrinologiska kliniken, Malmö
city: Stockholm
country: Sweden
facility: Centrum for Diabetes, Academical Specialist Centrum
city: Sundsvall
country: Sweden
facility: Medicinkliniken Sundsv
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset Uppsala
city: Västra Frölunda
country: Sweden
facility: Frölunda Specialistsjukhus
city: Örebro
country: Sweden
facility: Medicinmottagning1 Universitetssjukhuset Örebro
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 1452)
role: STUDY_DIRECTOR
References: