Effectiveness of Video Consultations in Type 1 Diabetes Patients Treated With Insulin Pumps in the Outpatient Clinic

NCT04612933 | Completed

• 1 other identifier: SHS-MS-09-2020
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Telemedicine is a solution to overcome distance and ensure the provision of healthcare services. This study aims to investigate the effects of conducting outpatient clinic visits remotely, for patients living with insulin pumps.

Conditions

Telemedicine; Insulin Dependent Diabetes Mellitus 1

Outcome Measures

Primary Outcomes (1)

• Change from baseline of Time in Range (TiR)

  % of TiR (3.9 -10.0 mmol/L)

  52 weeks

Secondary Outcomes (9)

• Change from baseline of Glycaemic variability

  52 weeks

• Change from baseline of Haemoglobin 1Ac

  52 weeks

• Audit of Diabetes Dependent Quality of Life version 19

  0 and 52 weeks

• Diabetes Treatment Satisfaction status

  0 and 52 weeks

• Diabetes Treatment Satisfaction Questionaire change

  52 weeks

Other Outcomes (2)

• Changes in Quality of Life: EuroQol 5-Dimension 5-Level (EQ-5D-5L)

  0 and 52 weeks

• Semi-structured interviews

  0 and 52 weeks

Study Arms (2)

Intervention group video consultations

EXPERIMENTAL

All appointments, scheduled and non-scheduled are by telemedicine using video to commutate with the health care professionals. Patients will follow their usual treatment.

Other: Intervention group video consultations

No intervention

NO INTERVENTION

All appointments, scheduled and non-scheduled are by face-face communication with the health care professionals. Patients will receive their usual treatment.

Interventions

Intervention group video consultations OTHER

All appointments, scheduled and non-scheduled are by telemedicine using video to commutate with the health care professionals. Patients will follow their usual treatment.

Intervention group video consultations

Eligibility Criteria

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

You may qualify if:

• Adult patients over 18 years of age
• Diagnosed with diabetes Type 1
• Patient has used insulin pump for at least 6 months

You may not qualify if:

• No internet access
• Unable to adhere to protocol.
• Unable to speak or read Danish.

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Sygehus Soenderjylland

Aabenraa, 6200, Denmark

Location

Related Publications (19)

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  PMID: 12556541 BACKGROUND

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  PMID: 23759390 BACKGROUND

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• Schultz ANO, Christensen R, Bollig G, Kidholm K, Brandt F. Effectiveness of video consultations in type 1 diabetes patients treated with insulin pumps in the outpatient clinic: a randomised controlled trial. Diabetologia. 2026 Feb;69(2):321-329. doi: 10.1007/s00125-025-06585-2. Epub 2025 Nov 7.

  PMID: 41198916 DERIVED

• Schultz ANO, Christensen R, Bollig G, Kidholm K, Brandt F. Effectiveness of video consultations in type 1 diabetes patients treated with insulin pumps in the outpatient clinic: protocol for a randomised controlled trial. BMJ Open. 2022 Apr 27;12(4):e058728. doi: 10.1136/bmjopen-2021-058728.

  PMID: 35477877 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

• Frans Brandt Kristensen, MD, Ph.D.

  Department of Endocrinology, Hospital of Southern Jutland

  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

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: November 3, 2020
• Study Start: June 28, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)