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

Telemedicine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04612933
• Other study ID #: SHS-MS-09-2020
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2021
• Est. completion date: June 2024

Study information

• Verified date: August 2023
• Source: University of Southern Denmark
• Contact: Anders Ørsted Schultz, MD
• Phone: +45 2614 6374
• Email: anos[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Telemedicine also has the potential to be a cost-effective solution due to reductions in travelling costs and saved working days, as well as increased patient satisfaction due to the reduction in transportation time.

Several studies have evaluated telemedicine for use in Diabetes Mellitus patients with an insulin pump. In all of these studies, the telemedicine group scheduled more contacts with the health care professionals than in the standard care group. To the investigator's knowledge, no one has investigated telemedicine, compared to standard care with the same number of scheduled contacts. The investigators believe telemedicine should increase the level of service and not increase the workload for health care professionals. A telemedical solution can provide patients with a more flexible alternative for visiting their health care provider rather having the burden of extra telemedicine appointments plus regular treatment.

Patients in rural Denmark may have a travelling time of 70 km (1 hour by car or several hours by public transport) to a specialised Diabetes Mellitus specialist centre. This may result in some patients choosing not to start or not being offered insulin pump treatment despite indications that an insulin pump is an optimal treatment choice. The challenge of distance also poses problems for patients in relation to technical problems or medical issues with the insulin pump. Telemedicine should be a solution for both patients and their Health Care Providers.

In this randomised controlled study, the effects of conducting clinical visits remotely, for patients living with insulin pumps will be investigated. Participants will be allocated to either Intervention (Standard care provide by video consultations) or standard care.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients over 18 years of age

• Diagnosed with diabetes Type 1

• Patient has used insulin pump for at least 6 months

Exclusion Criteria:

• No internet access

• Unable to adhere to protocol.

• Unable to speak or read Danish.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Insulin Dependent Diabetes Mellitus 1
• Telemedicine

Intervention

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

Locations

Country	Name	City	State
Denmark	Sygehus Soenderjylland	Aabenraa

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (17)

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Gonzalez-Molero I, Dominguez-Lopez M, Guerrero M, Carreira M, Caballero F, Rubio-Martin E, Linares F, Cardona I, Anarte MT, de Adana MS, Soriguer F. Use of telemedicine in subjects with type 1 diabetes equipped with an insulin pump and real-time continuous glucose monitoring. J Telemed Telecare. 2012 Sep;18(6):328-32. doi: 10.1258/jtt.2012.120103. Epub 2012 Aug 21. — View Citation

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Lee SWH, Ooi L, Lai YK. Telemedicine for the Management of Glycemic Control and Clinical Outcomes of Type 1 Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Studies. Front Pharmacol. 2017 May 30;8:330. doi: 10.3389/fphar.2017.00330. eCollection 2017. — View Citation

Levin K, Madsen JR, Petersen I, Wanscher CE, Hangaard J. Telemedicine diabetes consultations are cost-effective, and effects on essential diabetes treatment parameters are similar to conventional treatment: 7-year results from the Svendborg Telemedicine Diabetes Project. J Diabetes Sci Technol. 2013 May 1;7(3):587-95. doi: 10.1177/193229681300700302. — View Citation

Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, Raskin P, Zinman B; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005 Dec 22;353(25):2643-53. doi: 10.1056/NEJMoa052187. — View Citation

Papatheodorou K, Papanas N, Banach M, Papazoglou D, Edmonds M. Complications of Diabetes 2016. J Diabetes Res. 2016;2016:6989453. doi: 10.1155/2016/6989453. Epub 2016 Oct 16. No abstract available. — View Citation

Rasmussen BS, Froekjaer J, Bjerregaard MR, Lauritsen J, Hangaard J, Henriksen CW, Halekoh U, Yderstraede KB. A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers. Diabetes Care. 2015 Sep;38(9):1723-9. doi: 10.2337/dc15-0332. Epub 2015 Jun 26. — View Citation

Sood A, Watts SA, Johnson JK, Hirth S, Aron DC. Telemedicine consultation for patients with diabetes mellitus: a cluster randomised controlled trial. J Telemed Telecare. 2018 Jul;24(6):385-391. doi: 10.1177/1357633X17704346. Epub 2017 Apr 13. — View Citation

Stamler J, Vaccaro O, Neaton JD, Wentworth D. Diabetes, other risk factors, and 12-yr cardiovascular mortality for men screened in the Multiple Risk Factor Intervention Trial. Diabetes Care. 1993 Feb;16(2):434-44. doi: 10.2337/diacare.16.2.434. — View Citation

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* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Quality of Life: EuroQol 5-Dimension 5-Level (EQ-5D-5L)	EQ-5D-5L includes 5 domains each score from 1 to 5 with level 1 indicating no problem and level 5 indicating unable to/extreme problems.	0 and 52 weeks
Other	Semi-structured interviews	intervention group and Healthcare professionals	0 and 52 weeks
Primary	Change from baseline of Time in Range (TiR)	% of TiR (3.9 -10.0 mmol/L)	52 weeks
Secondary	Change from baseline of Glycaemic variability	(%GCV)	52 weeks
Secondary	Change from baseline of Haemoglobin 1Ac	HbA1C %	52 weeks
Secondary	Audit of Diabetes Dependent Quality of Life version 19	Audit of Diabetes Dependent Quality of Life version 19 (ADDQoL 19) includes19 items each score from -9 to 3, with lower scores reflecting maximum negative impact.	0 and 52 weeks
Secondary	Diabetes Treatment Satisfaction status	Diabetes treatment questionnaire, status (DTSQs) includes 8 items, each score from 0 to 6 with a higher score indicating better outcome	0 and 52 weeks
Secondary	Diabetes Treatment Satisfaction Questionaire change	Diabetes treatment questionnaire, change (DTSQc) includes 8 items, each score from 3+ to -3 with a higher score indicating better outcome DTSQc	52 weeks
Secondary	Change from baseline of time above target glucose range (TaR) level 1	% TaR (10.1-13.9 mmol/L)	52 weeks
Secondary	Change from baseline of time above target glucose range (TaR) level 2	% TaR (>13.9 mmol/L)	52 weeks
Secondary	Change from baseline of time spent below target glucose range (TbR ) level 1	%TbR (3.0-3.8 mmol/L)	52 weeks
Secondary	Change from baseline of time spent below target glucose range (TbR) level 2	% TbR (<3.0 mmol/L)	52 weeks