NCT01887431

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 26, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

3.1 years

First QC Date

June 18, 2013

Last Update Submit

January 28, 2017

Conditions

Type 1 Diabetes Mellitus

Keywords

Diabetes Mellitus, Type 1AdultInsulin Infusion SystemsTelecare

Outcome Measures

Primary Outcomes (1)

  • Change in Glycosylated Hemoglobin (Hba1c)

    From date of randomization every 3 months, up to one year

Secondary Outcomes (4)

  • Time spent on data analysis and telephone calls by team

    1 year

  • Number of severe hypoglycemic and diabetic ketoacidosis (DKA) events and hospitalizations

    1 year

  • Patients' quality of life

    1 year

  • Patients' satisfaction

    1 year

Study Arms (2)

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.

Other: Telecare

Conventional therapy

ACTIVE COMPARATOR

3-month routine clinic visits

Other: Conventional therapy

Interventions

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.

Telecare
Conventional therapyOTHER

3-month routine clinic visits

Conventional therapy

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maccabi Healthcare Services

Raanana, Israel

Location

Related Publications (1)

  • 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.

    PMID: 30783823DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dietitian

Study Record Dates

First Submitted

June 18, 2013

First Posted

June 26, 2013

Study Start

October 1, 2013

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

January 31, 2017

Record last verified: 2017-01

Locations

IL(1)