Telecare in Type 1 Diabetes (T1D) Patients Treated by Insulin Pump
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Telecare
Conventional therapy
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Diabetes Mellitus, Type 1, Adult, Insulin Infusion Systems, Telecare
Eligibility Criteria
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
Sites / Locations
- Maccabi Healthcare Services
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Telecare
Conventional therapy
Arm Description
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.
3-month routine clinic visits
Outcomes
Primary Outcome Measures
Change in Glycosylated Hemoglobin (Hba1c)
Secondary Outcome Measures
Time spent on data analysis and telephone calls by team
Number of severe hypoglycemic and diabetic ketoacidosis (DKA) events and hospitalizations
Patients' quality of life
Patients' satisfaction
Full Information
NCT ID
NCT01887431
First Posted
June 18, 2013
Last Updated
January 28, 2017
Sponsor
Assuta Hospital Systems
Collaborators
Maccabi Healthcare Services, Israel
1. Study Identification
Unique Protocol Identification Number
NCT01887431
Brief Title
Telecare in Type 1 Diabetes (T1D) Patients Treated by Insulin Pump
Official Title
Telecare in Adults With Type 1 Diabetes Mellitus Treated by Insulin Pump - A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assuta Hospital Systems
Collaborators
Maccabi Healthcare Services, Israel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
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. .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Diabetes Mellitus, Type 1, Adult, Insulin Infusion Systems, Telecare
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telecare
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional therapy
Arm Type
Active Comparator
Arm Description
3-month routine clinic visits
Intervention Type
Other
Intervention Name(s)
Telecare
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional therapy
Intervention Description
3-month routine clinic visits
Primary Outcome Measure Information:
Title
Change in Glycosylated Hemoglobin (Hba1c)
Time Frame
From date of randomization every 3 months, up to one year
Secondary Outcome Measure Information:
Title
Time spent on data analysis and telephone calls by team
Time Frame
1 year
Title
Number of severe hypoglycemic and diabetic ketoacidosis (DKA) events and hospitalizations
Time Frame
1 year
Title
Patients' quality of life
Time Frame
1 year
Title
Patients' satisfaction
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Maccabi Healthcare Services
City
Ra'anana
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30783823
Citation
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.
Results Reference
derived
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Telecare in Type 1 Diabetes (T1D) Patients Treated by Insulin Pump
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