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

April 5, 2015 updated by: Reem Mohammad Alamoudi

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

142

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Dammam, Saudi Arabia, 31412
        • National Guards Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The target population of our study is all patients with type1DM treated at three National Guard institutiuons in three different cities of Saudi Arabia (Riyadh, Alahsa, Dammam) with either insulin pump or MDI

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Insulin pump
MDI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of hypoglycemia
Time Frame: 5 weeks
Rates of hypoglycemia during fasting ramadan in insulin pump users and MDI users [Hypoglycemia defined as blood glucose level ≤ 70 mg/dl ( 3.9 mmol/l)]
5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of fasting days lost
Time Frame: 5 weeks
To estimate the number of days they needed to brake their fast due to acute complications (hypoglycemia, severe hyperglycemia, or DKA).
5 weeks
Glycemic control
Time Frame: Two (2) months
To assess the glycemic control in the two groups using HbA1c and Fructosamine assays.
Two (2) months
overnight hypoglycemia
Time Frame: 5 weeks
To estimate the rates of overnight hyperglycemia in both groups.
5 weeks
Rate of acute complications
Time Frame: 5 weeks
To estimate presence of severe hyperglycemia and /or DKA episodes in both groups
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reem Mohammad Alamoudi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

September 4, 2013

First Submitted That Met QC Criteria

September 9, 2013

First Posted (Estimate)

September 13, 2013

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 5, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RE12-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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