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OpenTrials
Completed

NCT Number: NCT03697369

Glycemic Control and Treatment Satisfaction in Children With Type 1 Diabetes Using Insulin Pumps

Background: The use of insulin pumps in pediatric patients with type 1 diabetes(T1D) has expanded, with lack of data comparing between the different devices.

Objective: to compare prospectively glycemic control, technical difficulties and quality of life (QOL) between 3 pump devices during the first year of use .

Methods: a prospective observational trial, based on clinical data retrieved during 12 months of follow- up. Inclusion criteria included T1D patients, ages 1-18 years, who started pump therapy as part of their clinical care in 4 university affiliated medical centers. The devices fully reimbursed by national health insurance are: MiniMed™ 640G , MiniMed® Veo™, Animas® Vibe®, and Abbott Omnipod®. Comparison parameters included quality of life (QOL), frequency of technical difficulties, skin reactions, discontinuation rate, glycated hemoglobin (HBA1C), mean glucose, total daily insulin dose (TDD) , pump setting parameters and BMI.

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Key information

Conditions

T1DM

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of T1D recorded by a pediatric endocrinologist
  • Attending periodic clinic visits, and starting pump mode of therapy between May 2015 and March 2017.

Exclusion criteria

  • No restrictions on HbA1c value at study recruitment or on use of CGMS -

Treatment and study plan

Primary outcomes

  1. Technical difficulties differences

    Time frame: 2 years from patient first enrollment

    All patients were asked 5 questions regarding monthly frequency of technical problems including the need to use extra sets and the level of pain at catheter insertion

  2. Quality Of Life (QOL)

    Time frame: 2 years from patient first enrollment

    QOL assessment was performed utilizing The Diabetes Treatment Satisfaction Questionnaires (DTSQ) for teens and for parents, separately [14]. The teens DTSQ contained 12 items scores on six-point scales, of which 9 were summed, the parents DTSQ contained 14 items, of which 9 were summed. Maximal grade was 42.

  3. Skin reactions differences

    Time frame: 2 years from patient first enrollment

    skin assessment at the pump insertion site (itching and redness).

  4. Discontinuation rate differences

    Time frame: 2 years from patient first enrollment

    Comparison between constant pump users and those who discontinued

Secondary outcomes

  1. Glycemic control and metabolic parameters differences: Insulin TDD

    Time frame: 2 years from patient first enrollment

    The difference in glycemic control parameters and metabolic parameters after 3, 6 and 12 months of follow up, between the pumps devices. Insulin TDD, as reported by pump printout data

  2. Glycemic control and metabolic parameters differences: HbA1c%

    Time frame: 2 years from patient first enrollment

    The difference in HbA1c% as measured by each center ll local lab.

  3. Glycemic control and metabolic parameters differences:Glucose Mean & SD

    Time frame: 2 years from patient first enrollment

    Glucose Mean & SD as recorded by SMBG

  4. Glycemic control and metabolic parameters differences:Number of SMBG per day

    Time frame: 2 years from patient first enrollment

    Data derived from data recorded by SMBG

  5. Glycemic control and metabolic parameters differences:BMI SDS

    Time frame: 2 years from patient first enrollment

    according to Center for Disease Control (CDC) growth charts scale

Sponsors and collaborators

Lead sponsor

Assaf-Harofeh Medical Center

Other Gov

Collaborators

  • Maccabi Healthcare Services, Israel
  • Sheba Medical Center
  • Wolfson Medical Center

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 5, 2018
Registry last updated
Oct 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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