TelemedicineNCT04612933
Effectiveness of Video Consultations in Type 1 Diabetes Patients Treated With Insulin Pumps in the Outpatient Clinic
A study testing Intervention group video consultations in people with Telemedicine and Insulin Dependent Diabetes Mellitus 1, run by University of Southern Denmark at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Telemedicine, Insulin Dependent Diabetes Mellitus 1
- What is being tested?
- Intervention group video consultations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Jun 2021to 30 Jun 2024
- Phase
- Interventional
- 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
Who may be able to join
- Adult patients over 18 years of age
- Diagnosed with diabetes Type 1
- Patient has used insulin pump for at least 6 months
Who cannot join
- No internet access
- Unable to adhere to protocol.
- Unable to speak or read Danish.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Being tested
- Intervention group video consultations
- 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.
Intervention group video consultationsOther
All appointments, scheduled and non-scheduled are by telemedicine using video to commutate with the health care professionals.
Patients will follow their usual treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of Time in Range (TiR)
% of TiR (3.9 -10.0 mmol/L)
Measured: 52 weeks
Secondary outcomes (9)
Change from baseline of Glycaemic variability
(%GCV)
Measured: 52 weeks
Change from baseline of Haemoglobin 1Ac
HbA1C %
Measured: 52 weeks
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.
Measured: 0 and 52 weeks
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
Measured: 0 and 52 weeks
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
Measured: 52 weeks
Change from baseline of time above target glucose range (TaR) level 1
% TaR (10.1-13.9 mmol/L)
Measured: 52 weeks
Change from baseline of time above target glucose range (TaR) level 2
% TaR (>13.9 mmol/L)
Measured: 52 weeks
Change from baseline of time spent below target glucose range (TbR ) level 1
%TbR (3.0-3.8 mmol/L)
Measured: 52 weeks
Change from baseline of time spent below target glucose range (TbR) level 2
% TbR (<3.0 mmol/L)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start28 Jun 2021
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frans Brandt Kristensen, MD, Ph.D., Study director, Department of Endocrinology, Hospital of Southern Jutland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612933
- Sponsor's protocol ID
- SHS-MS-09-2020
- Status last verified
- Mar 2025
- First submitted
- 15 Oct 2020
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang PH, Lau J, Chalmers TC. Meta-analysis of effects of intensive blood-glucose control on late complications of type I diabetes. Lancet. 1993 May 22;341(8856):1306-9. doi: 10.1016/0140-6736(93)90816-y.
PubMed 8098449Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
PubMed 8366922Papatheodorou 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.
PubMed 27822482Kannel WB, McGee DL. Diabetes and cardiovascular disease. The Framingham study. JAMA. 1979 May 11;241(19):2035-8. doi: 10.1001/jama.241.19.2035.
PubMed 430798Haffner SM, Lehto S, Ronnemaa T, Pyorala K, Laakso M. Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med. 1998 Jul 23;339(4):229-34. doi: 10.1056/NEJM199807233390404.
PubMed 9673301Khoury JC, Kleindorfer D, Alwell K, Moomaw CJ, Woo D, Adeoye O, Flaherty ML, Khatri P, Ferioli S, Broderick JP, Kissela BM. Diabetes mellitus: a risk factor for ischemic stroke in a large biracial population. Stroke. 2013 Jun;44(6):1500-4. doi: 10.1161/STROKEAHA.113.001318. Epub 2013 Apr 25.
PubMed 23619130Laing SP, Swerdlow AJ, Carpenter LM, Slater SD, Burden AC, Botha JL, Morris AD, Waugh NR, Gatling W, Gale EA, Patterson CC, Qiao Z, Keen H. Mortality from cerebrovascular disease in a cohort of 23 000 patients with insulin-treated diabetes. Stroke. 2003 Feb;34(2):418-21. doi: 10.1161/01.str.0000053843.03997.35.
PubMed 12574553Stamler 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.
PubMed 8432214Nathan 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.
PubMed 16371630Gaede P, Vedel P, Larsen N, Jensen GV, Parving HH, Pedersen O. Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med. 2003 Jan 30;348(5):383-93. doi: 10.1056/NEJMoa021778.
PubMed 12556541Levin 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.
PubMed 23759390Lee 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.
PubMed 28611672Sood 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.
PubMed 28406066Gonzalez-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.
PubMed 22912487Yaron M, Sher B, Sorek D, Shomer M, Levek N, Schiller T, Gaspar M, Frumkin Ben-David R, Mazor-Aronovitch K, Tish E, Shapira Y, Pinhas-Hamiel O. A randomized controlled trial comparing a telemedicine therapeutic intervention with routine care in adults with type 1 diabetes mellitus treated by insulin pumps. Acta Diabetol. 2019 Jun;56(6):667-673. doi: 10.1007/s00592-019-01300-1. Epub 2019 Feb 19.
PubMed 30783823
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Video Consultations in Type 1 Diabetes Patients Treated With Insulin Pumps in the Outpatient Clinic
- ClinicalTrials.gov ID
- NCT04612933
- Acronym / sponsor ID
- SHS-MS-09-2020
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group video consultations | Experimental | Other: Intervention group video consultationsAll appointments, scheduled and non-scheduled are by telemedicine using video to commutate with the health care professionals. Patients will follow their usual treatment. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients over 18 years of age
- Diagnosed with diabetes Type 1
- Patient has used insulin pump for at least 6 months
Key exclusion criteria (3 listed)
- No internet access
- Unable to adhere to protocol.
- Unable to speak or read Danish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention group video consultationsAll 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 |
Primary outcome
Change from baseline of Time in Range (TiR)
Time frame: 52 weeks
% of TiR (3.9 -10.0 mmol/L)
9 secondary outcomes
Change from baseline of Glycaemic variability
Time frame: 52 weeks
Change from baseline of Haemoglobin 1Ac
Time frame: 52 weeks
Audit of Diabetes Dependent Quality of Life version 19
Time frame: 0 and 52 weeks
Diabetes Treatment Satisfaction status
Time frame: 0 and 52 weeks
Diabetes Treatment Satisfaction Questionaire change
Time frame: 52 weeks
Change from baseline of time above target glucose range (TaR) level 1
Time frame: 52 weeks
Change from baseline of time above target glucose range (TaR) level 2
Time frame: 52 weeks
Change from baseline of time spent below target glucose range (TbR ) level 1
Time frame: 52 weeks
Change from baseline of time spent below target glucose range (TbR) level 2
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Background: PubMed 8098449Wang PH, Lau J, Chalmers TC. Meta-analysis of effects of intensive blood-glucose control on late complications of type I diabetes. Lancet. 1993 May 22;341(8856):1306-9. doi: 10.1016/0140-6736(93)90816-y.
- Background: PubMed 8366922Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
- Background: PubMed 27822482Papatheodorou 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.
- Background: PubMed 430798Kannel WB, McGee DL. Diabetes and cardiovascular disease. The Framingham study. JAMA. 1979 May 11;241(19):2035-8. doi: 10.1001/jama.241.19.2035.
- Background: PubMed 9673301Haffner SM, Lehto S, Ronnemaa T, Pyorala K, Laakso M. Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med. 1998 Jul 23;339(4):229-34. doi: 10.1056/NEJM199807233390404.
- Background: PubMed 23619130Khoury JC, Kleindorfer D, Alwell K, Moomaw CJ, Woo D, Adeoye O, Flaherty ML, Khatri P, Ferioli S, Broderick JP, Kissela BM. Diabetes mellitus: a risk factor for ischemic stroke in a large biracial population. Stroke. 2013 Jun;44(6):1500-4. doi: 10.1161/STROKEAHA.113.001318. Epub 2013 Apr 25.
- Background: PubMed 12574553Laing SP, Swerdlow AJ, Carpenter LM, Slater SD, Burden AC, Botha JL, Morris AD, Waugh NR, Gatling W, Gale EA, Patterson CC, Qiao Z, Keen H. Mortality from cerebrovascular disease in a cohort of 23 000 patients with insulin-treated diabetes. Stroke. 2003 Feb;34(2):418-21. doi: 10.1161/01.str.0000053843.03997.35.
- Background: PubMed 8432214Stamler 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.
- Background: PubMed 16371630Nathan 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.
- Background: PubMed 12556541Gaede P, Vedel P, Larsen N, Jensen GV, Parving HH, Pedersen O. Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med. 2003 Jan 30;348(5):383-93. doi: 10.1056/NEJMoa021778.
- Background: PubMed 23759390Levin 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.
- Background: PubMed 28611672Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frans Brandt Kristensen, MD, Ph.D. study director
Department of Endocrinology, Hospital of Southern Jutland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group video consultations in people with Telemedicine and Insulin Dependent Diabetes Mellitus 1, run by University of Southern Denmark at 1 site in Denmark.
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 3 inclusion and 3 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 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 from baseline of Time in Range (TiR) (time frame: 52 weeks). 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 NCT04612933, which also lists 19 linked publications.
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 19 Mar 2025.