TY - JOUR
T1 - Effectiveness of video consultations in type 1 diabetes patients treated with insulin pumps in the outpatient clinic
T2 - protocol for a randomised controlled trial
AU - Schultz, Anders Nikolai Ørsted
AU - Christensen, Robin
AU - Bollig, Georg
AU - Kidholm, Kristian
AU - Brandt, F
N1 - © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2022/4/27
Y1 - 2022/4/27
N2 - INTRODUCTION: The purpose of the study is to assess the effectiveness of video consultations in patients with type 1 diabetes mellitus (DM) treated with insulin pumps in the outpatient clinic.METHODS AND ANALYSIS: A 52 weeks' duration, open-label, randomised controlled trial will be conducted, enrolling 100 patients with type 1 DM currently treated with insulin pump.Patients will be recruited from the diabetes outpatient clinic at Hospital of Southern Jutland, Department of internal medicine, Sønderborg. Participants will be randomised to either video consultations (experimental intervention) or standard care (control comparator). Participants in the video consultation group will follow their standard care treatment but will have all of their scheduled and non-scheduled appointments by video consultation. The control group will follow their standard care treatment as usual, having all their appointments at the outpatient centre. Primary outcome will be change from baseline of time in range (3.9-10.0 mmol/L).ETHICS AND DISSEMINATION: The study has been approved by the Regional Committe on Health Research Ethics for Southern Denmark, S-20200039G Acadre 20/12922. We will present the results of the trial at international conferences as well as publish the results of the trial in (a) peer-reviewed scientific journal(s).TRIAL REGISTRATION NUMBER: NCT04612933.
AB - INTRODUCTION: The purpose of the study is to assess the effectiveness of video consultations in patients with type 1 diabetes mellitus (DM) treated with insulin pumps in the outpatient clinic.METHODS AND ANALYSIS: A 52 weeks' duration, open-label, randomised controlled trial will be conducted, enrolling 100 patients with type 1 DM currently treated with insulin pump.Patients will be recruited from the diabetes outpatient clinic at Hospital of Southern Jutland, Department of internal medicine, Sønderborg. Participants will be randomised to either video consultations (experimental intervention) or standard care (control comparator). Participants in the video consultation group will follow their standard care treatment but will have all of their scheduled and non-scheduled appointments by video consultation. The control group will follow their standard care treatment as usual, having all their appointments at the outpatient centre. Primary outcome will be change from baseline of time in range (3.9-10.0 mmol/L).ETHICS AND DISSEMINATION: The study has been approved by the Regional Committe on Health Research Ethics for Southern Denmark, S-20200039G Acadre 20/12922. We will present the results of the trial at international conferences as well as publish the results of the trial in (a) peer-reviewed scientific journal(s).TRIAL REGISTRATION NUMBER: NCT04612933.
KW - Ambulatory Care Facilities
KW - Diabetes Mellitus, Type 1/drug therapy
KW - Humans
KW - Insulin/therapeutic use
KW - Insulin Infusion Systems
KW - Randomized Controlled Trials as Topic
KW - Remote Consultation
UR - http://www.scopus.com/inward/record.url?scp=85128910645&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2021-058728
DO - 10.1136/bmjopen-2021-058728
M3 - Journal article
C2 - 35477877
SN - 2399-9772
VL - 12
SP - e058728
JO - BMJ Paediatrics Open
JF - BMJ Paediatrics Open
IS - 4
M1 - e058728
ER -