Health-related Quality of Life and Psychosocial Aspects of Diabetes Technology (Insulin Pumps)

NCT ID: NCT04756011

Last Updated: 2021-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-15

Study Completion Date

2021-02-01

Brief Summary

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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).

Detailed Description

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Conditions

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T1DM Health Related Quality of Life Insulin Pump

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group A (insulin pump)

30 patients who are on insulin pump.

Health related quality of life

Intervention Type OTHER

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

Group B (MDI)

30 patients who are on multiple daily injection.

Health related quality of life

Intervention Type OTHER

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

Interventions

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Health related quality of life

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 1\. Other types of DM e.g., T2DM, MODY.
* 2\. Patients with other comorbidities; cardiac, renal, neurological, hepatic ….etc.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ain shams University

Cairo, Abbasia, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 35690827 (View on PubMed)

Other Identifiers

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Health related quality of life

Identifier Type: -

Identifier Source: org_study_id

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