Incidence of Hypoglycemia During Ramadan in Patients With Type1 Diabetes on Insulin Pump Versus Multi Dose Injection

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

142 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-11-30

Brief Summary

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Managing patients with type1 diabetes when fasting Ramadan is very challenging. Insulin pump offers the advantage of flexibility and precision to administering insulin and has been proven to reduce severe hypoglycemia compared to multi-dose injection (MDI). However, there are extremely limited studies on the difference between insulin pump compared to MDI on the incidence of hypoglycemia and other acute complications during fasting Ramadan

The investigators hypothesized that insulin pump would be associated with less hypoglycemic events during fasting Ramadan compared to MDI without deterioration in glycemic control. Results of this study are descriptive but will fill a current gap in knowledge and may contribute to development of future guidelines for the management of type1DM during Ramadan.

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Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Insulin pump

No interventions assigned to this group

MDI

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. DM type 1
2. Age ≥14 years
3. Patients on insulin pump (more than 3 months)
4. Patients on MDI (glargine or detemir combined with aspart or lispro) regimen
5. Diagnosis of type 1 DM of more than 6 months.
6. Willing to do Self Monitoring Blood Sugar (SMBG)
7. Have no other contraindication to fast

Exclusion Criteria

1. Patient with renal or hepatic impairment
2. Patient with diagnosed adrenal insufficiency
3. Pregnancy
4. Alcoholism
5. Any diagnosed psychiatric disease
6. Can not do SMBG

Minimum Eligible Age

14 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No