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Telecare in Type 1 Diabetes (T1D) Patients Treated by Insulin Pump

Telecare in Adults With Type 1 Diabetes Mellitus Treated by Insulin Pump - A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01887431
Enrollment
66
Registered
2013-06-26
Start date
2013-10-31
Completion date
2016-11-30
Last updated
2017-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

Diabetes Mellitus, Type 1, Adult, Insulin Infusion Systems, Telecare

Brief 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.

Detailed description

1. Objectives 1. To evaluate the effect of telecare on glycemic control for patients with type 1 diabetes (T1DM). 2. To assess the cost of telecare to Maccabi, the patient and the economy. 3. To assess patients' quality of life and satisfaction with telecare intervention. 4. To assess the effect of telecare intervention on insulin adjustment to consumed carbohydrates. 2. Working hypothesis Telecare can be used for efficient management of T1DM in adults using insulin pump, in lieu of frequent clinic visits. 3. 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 4. 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. .

Interventions

OTHERConventional therapy

3-month routine clinic visits

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.

Sponsors

Maccabi Healthcare Services, Israel
CollaboratorOTHER
Assuta Hospital Systems
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with T1D lasted \>1 year, age 22 and up, using insulin pump * Patients possessing a mobile phone and internet access

Exclusion criteria

* Patients with Severe target organ damage * Patients with Mental retardation * Patients with Eating disorders * Pregnant patients or patients planning pregnancy

Design outcomes

Primary

MeasureTime frame
Change in Glycosylated Hemoglobin (Hba1c)From date of randomization every 3 months, up to one year

Secondary

MeasureTime frame
Time spent on data analysis and telephone calls by team1 year
Number of severe hypoglycemic and diabetic ketoacidosis (DKA) events and hospitalizations1 year
Patients' quality of life1 year
Patients' satisfaction1 year

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026