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

Completed

• Conditions: Type 1 Diabetes

• Registration Number: NCT01941238
• Lead Sponsor: Reem Mohammad Alamoudi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Primary Completion: 2013-09
• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2013-09-09
• Study First Posted: 2013-09-13
• Study Completion: 2014-11
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-05
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Guards Hospital; 🇸🇦 Dammam, Saudi Arabia