Type 1 Diabetes MellitusNCT01887431
Telecare in Type 1 Diabetes (T1D) Patients Treated by Insulin Pump
A study testing Telecare and Conventional therapy in people with Type 1 Diabetes Mellitus, run by Assuta Hospital Systems at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether Telecare can be used for efficient management of adults with Type 1 Diabetes Mellitus using insulin pump, in lieu of frequent clinic visits. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Telecare and Conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2013to Nov 2016
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with T1D lasted >1 year, age 22 and up, using insulin pump
- Patients possessing a mobile phone and internet access
Who cannot join
- Patients with Severe target organ damage
- Patients with Mental retardation
- Patients with Eating disorders
- Pregnant patients or patients planning pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telecare in Adults With Type 1 Diabetes Mellitus Treated by Insulin Pump - A Randomized Controlled Trial
The purpose of this study is to determine whether Telecare can be used for efficient management of adults with Type 1 Diabetes Mellitus using insulin pump, in lieu of frequent clinic visits.
Read the detailed description
- Objectives
- To evaluate the effect of telecare on glycemic control for patients with type 1 diabetes (T1DM).
- To assess the cost of telecare to Maccabi, the patient and the economy.
- To assess patients' quality of life and satisfaction with telecare intervention.
- To assess the effect of telecare intervention on insulin adjustment to consumed carbohydrates.
- Working hypothesis Telecare can be used for efficient management of T1DM in adults using insulin pump, in lieu of frequent clinic visits.
- Methodology A randomized controlled prospective trial for one year. Intervention group: Each patient will transmit glucometer and pump data electronically via a web site (Medtronic Carelink internet site www.carelink.minimed.com) to diabetes team and will receive feedback by telephone. Frequency of data transfer will be directly related to patients' metabolic control. In addition to data transmission Patient of the intervention group will be arriving during the intervention year for 3 clinic visit at the following time point : 0, 6 and 12 month. Control group: 3-month routine clinic visits
- Significance of the proposed research (its uniqueness and innovation) Telecare potentially offers a method for efficient continuous care management of patients with T1DM using insulin pump in lieu of clinic visits. It enables real time responses of clinical personnel and increases patient involvement. This trial will be the first telecare intervention lasting for one year to determine if treatment is as efficient as face to face visits, thus enabling cost reduction and time saving without affecting the quality of care. .
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Telecare, Conventional therapy
- Keywords
- Diabetes Mellitus, Type 1, Adult, Insulin Infusion Systems, Telecare
- 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.
TelecareOther
Each patient will transmit glucometer and pump data electronically via a web site (Medtronic Carelink internet site www.carelink.minimed.com) to diabetes team and will receive feedback by telephone. Frequency of data transfer will be directly related to patients' metabolic control. In addition to data transmission Patient of the intervention group will be arriving during the intervention year for 3 clinic visit at the following time point : 0, 6 and 12 month.
Conventional therapyOther
3-month routine clinic visits
| Study group | Role | What they receive |
|---|---|---|
| Telecare | Experimental | Each patient will transmit glucometer and pump data electronically via a web site to diabetes team and will receive feedback by telephone. Frequency of data transfer will be directly related to patients' metabolic control. Receives: Other: Telecare |
| Conventional therapy | Active comparator | 3-month routine clinic visits Receives: Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycosylated Hemoglobin (Hba1c)
Measured: From date of randomization every 3 months, up to one year
Secondary outcomes (4)
Time spent on data analysis and telephone calls by team
Measured: 1 year
Number of severe hypoglycemic and diabetic ketoacidosis (DKA) events and hospitalizations
Measured: 1 year
Patients' quality of life
Measured: 1 year
Patients' satisfaction
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Hospital Systems
- Sponsor type
- University, hospital or other
- Collaborators
- Maccabi Healthcare Services, Israel
- Responsible party
- Principal investigator, Bruria Sher, Assuta Hospital Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887431
- Sponsor's protocol ID
- 71156
- Status last verified
- Jan 2017
- First submitted
- 18 Jun 2013
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yaron 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 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telecare in Adults With Type 1 Diabetes Mellitus Treated by Insulin Pump - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01887431
- Acronym / sponsor ID
- 71156
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Type 1, Adult, Insulin Infusion Systems, Telecare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Assuta Hospital SystemsUniversity, hospital or other
- Collaborators
- Maccabi Healthcare Services, Israel
- Study start
- Oct 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 26 Jun 2013 (estimated)
- 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.
The purpose of this study is to determine whether Telecare can be used for efficient management of adults with Type 1 Diabetes Mellitus using insulin pump, in lieu of frequent clinic visits.
Detailed description
- Objectives
- To evaluate the effect of telecare on glycemic control for patients with type 1 diabetes (T1DM).
- To assess the cost of telecare to Maccabi, the patient and the economy.
- To assess patients' quality of life and satisfaction with telecare intervention.
- To assess the effect of telecare intervention on insulin adjustment to consumed carbohydrates.
- Working hypothesis Telecare can be used for efficient management of T1DM in adults using insulin pump, in lieu of frequent clinic visits.
- Methodology A randomized controlled prospective trial for one year. Intervention group: Each patient will transmit glucometer and pump data electronically via a web site (Medtronic Carelink internet site www.carelink.minimed.com) to diabetes team and will receive feedback by telephone. Frequency of data transfer will be directly related to patients' metabolic control. In addition to data transmission Patient of the intervention group will be arriving during the intervention year for 3 clinic visit at the following time point : 0, 6 and 12 month. Control group: 3-month routine clinic visits
- Significance of the proposed research (its uniqueness and innovation) Telecare potentially offers a method for efficient continuous care management of patients with T1DM using insulin pump in lieu of clinic visits. It enables real time responses of clinical personnel and increases patient involvement. This trial will be the first telecare intervention lasting for one year to determine if treatment is as efficient as face to face visits, thus enabling cost reduction and time saving without affecting the quality of care. .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telecare | Experimental | Other: TelecareEach patient will transmit glucometer and pump data electronically via a web site to diabetes team and will receive feedback by telephone. Frequency of data transfer will be directly related to patients' metabolic control. |
| Conventional therapy | Active comparator | Other: Conventional therapy3-month routine clinic visits |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with T1D lasted >1 year, age 22 and up, using insulin pump
- Patients possessing a mobile phone and internet access
Key exclusion criteria (4 listed)
- Patients with Severe target organ damage
- Patients with Mental retardation
- Patients with Eating disorders
- Pregnant patients or patients planning pregnancy
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 |
|---|---|---|
| TelecareEach patient will transmit glucometer and pump data electronically via a web site (Medtronic Carelink internet site www.carelink.minimed.com) to diabetes team and will receive feedback by telephone. Frequency of data transfer will be directly related to patients' metabolic control. In addition to data transmission Patient of the intervention group will be arriving during the intervention year for 3 clinic visit at the following time point : 0, 6 and 12 month. | Other | Telecare |
| Conventional therapy3-month routine clinic visits | Other | Conventional therapy |
Primary outcome
Change in Glycosylated Hemoglobin (Hba1c)
Time frame: From date of randomization every 3 months, up to one year
4 secondary outcomes
Time spent on data analysis and telephone calls by team
Time frame: 1 year
Number of severe hypoglycemic and diabetic ketoacidosis (DKA) events and hospitalizations
Time frame: 1 year
Patients' quality of life
Time frame: 1 year
Patients' satisfaction
Time frame: 1 year
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 31 Jan 2017.
- Derived from this study: PubMed 30783823Yaron 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.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telecare and Conventional therapy in people with Type 1 Diabetes Mellitus, run by Assuta Hospital Systems at 1 site in Israel.
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 2 inclusion and 4 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 31 Jan 2017. 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 Israel. 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 in Glycosylated Hemoglobin (Hba1c) (time frame: From date of randomization every 3 months, up to one year). 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 NCT01887431, which also lists 1 linked publication.
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 31 Jan 2017.