NCT04756011

Brief Summary

This study will be prospective comparative trial comparing between insulin pumps vs Multiple daily injections (MDI) in treatment of type 1 diabetes mellitus (T1DM) in terms of health- related quality of life (HRQL) and efficacy of glycemic control (HbA1c level ) Hypothesis: Type 1 diabetes is characterized by autoimmune destruction of insulin-secreting pancreatic b cells leading to disturbed glucose regulation and overt hyperglycemia which leads to variable consequences and complication. Consequently, individuals with type 1 diabetes have a lifelong dependency on insulin replacement therapy. Aim of the Work: To compare the psychosocial impact of insulin pumps versus multiple daily injections in treatment of type 1 diabetes mellitus (Via questionnaire) in terms of health-related quality of life and efficacy of glycemic control (HbA1c level).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

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

Study Start

First participant enrolled

March 15, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

10 months

First QC Date

February 12, 2021

Last Update Submit

February 20, 2021

Conditions

T1DMHealth Related Quality of LifeInsulin Pump

Keywords

Insulin pumpT1DMHRQL

Outcome Measures

Primary Outcomes (4)

  • Confidence in diabetes self care questionnaire (CIDS)

    the CIDS scale, assessment included HbA1c, emotional distress, fear of hypoglycemia, self-esteem, anxiety, depression, and self-care behavior. The CIDS scale is a reliable and valid measure of diabetes-specific self-efficacy for use in patients with type 1 diabetes. High psychometric similarity allows for cross-cultural comparisons.

    10 min

  • socioeconomic level of the family scale

    Assessment of family socioeconomic standard

    5 minutes

  • MINI-KID (Mini International Neuropsychiatric Interview )

    Mini International Neuropsychiatric Interview for Children and Adolescents

    25 minutes

  • Evaluation of health-related quality of life (HRQL)

    HRQL was measured by the Peds-QL 4.0 11,22. The 23-item Peds-QL 4.0 generic core scales encompass (a) physical functioning (eight items), (b) emotional functioning (five items), (c) social functioning (five items), and (d) school functioning (five items). The physical health summary score (eight items) is the same as the physical functioning scale. To create the psychosocial health summary score (15 items), the mean is computed as the sum of the items divided by the number of items answered in the emotional, social, and school functioning scales.

    5 minutes

Study Arms (2)

Group A (insulin pump)

30 patients who are on insulin pump.

Other: Health related quality of life

Group B (MDI)

30 patients who are on multiple daily injection.

Other: Health related quality of life

Interventions

Health related quality of lifeOTHER

Confidence in diabetes self care questionnaire the socioeconomic level of the family scale MINI-KID the Peds-QL

Group A (insulin pump)Group B (MDI)

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients from Ain shams pediatric and adolescent diabetes unit(PADU)

You may qualify if:

  • Type 1 diabetes mellitus.
  • Patients who are on insulin pumps must be for at least 3 months on them

You may not qualify if:

  • \. Other types of DM e.g., T2DM, MODY.
  • \. Patients with other comorbidities; cardiac, renal, neurological, hepatic ….etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams University

Cairo, Abbasia, 11517, Egypt

Location

Related Publications (1)

  • El Samahy MH, Salah NY, Abdeen MS, Falastin BRK. Psychosocial aspects of continuous subcutaneous insulin infusion in children with type 1 diabetes in Egypt; a limited resources country perspective. Diabetol Metab Syndr. 2022 Jun 11;14(1):82. doi: 10.1186/s13098-022-00853-6.

    PMID: 35690827DERIVED

MeSH Terms

Interventions

Quality of Life

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
11 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2021

First Posted

February 16, 2021

Study Start

March 15, 2020

Primary Completion

January 17, 2021

Study Completion

February 1, 2021

Last Updated

February 23, 2021

Record last verified: 2021-02

Locations

EG(1)