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

NCT03697369 | Completed DMC

• 1 other identifier: 0073-15-ASF
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

T1DM

Outcome Measures

Primary Outcomes (4)

• Technical difficulties differences

  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 years from patient first enrollment

• Quality Of Life (QOL)

  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.

  2 years from patient first enrollment

• Skin reactions differences

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

  2 years from patient first enrollment

• Discontinuation rate differences

  Comparison between constant pump users and those who discontinued

  2 years from patient first enrollment

Secondary Outcomes (5)

• Glycemic control and metabolic parameters differences: Insulin TDD

  2 years from patient first enrollment

• Glycemic control and metabolic parameters differences: HbA1c%

  2 years from patient first enrollment

• Glycemic control and metabolic parameters differences:Glucose Mean & SD

  2 years from patient first enrollment

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

  2 years from patient first enrollment

• Glycemic control and metabolic parameters differences:BMI SDS

  2 years from patient first enrollment

Study Arms (1)

Observation group

Individuals with T1D ages 0-20 years who switched management modality from MDI to pump as part of their clinical care and were followed up prospectively in the next 12 months.

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population included all individuals with T1D ages 0-20 years who switched management modality from MDI to pump as part of their clinical care, and were managed by the pediatric diabetes teams from the AWeSoMe Study Group ( four pediatric diabetes multidisciplinary clinics in Israel; Assaf Harofeh Medical Center, E. Wolfson Medical Center, Edmond and Lily Safra Children's Hospital, and Maccabi National Juvenile Diabetes Center).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead
• Wolfson Medical Center: collaborator
• Sheba Medical Center: collaborator
• Maccabi Healthcare Services, Israel: collaborator

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: October 5, 2018
• Study Start: May 31, 2015
• Primary Completion: July 31, 2017
• Study Completion: August 31, 2017
• Last Updated: October 5, 2018

Record last verified: 2018-10