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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941238
• Other study ID #: RE12-002
• Status: Completed
• Phase: N/A
• First received: September 4, 2013
• Last updated: April 5, 2015
• Start date: July 2013
• Est. completion date: November 2014

Study information

• Verified date: April 2015
• Source: King Abdullah International Medical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: November 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes

Locations

Country	Name	City	State
Saudi Arabia	National Guards Hospital	Dammam

Sponsors (1)

Lead Sponsor	Collaborator
Reem Mohammad Alamoudi

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hypoglycemia	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	Yes
Secondary	Number of fasting days lost	To estimate the number of days they needed to brake their fast due to acute complications (hypoglycemia, severe hyperglycemia, or DKA).	5 weeks	No
Secondary	Glycemic control	To assess the glycemic control in the two groups using HbA1c and Fructosamine assays.	Two (2) months	No
Secondary	overnight hypoglycemia	To estimate the rates of overnight hyperglycemia in both groups.	5 weeks	Yes
Secondary	Rate of acute complications	To estimate presence of severe hyperglycemia and /or DKA episodes in both groups	5 weeks	Yes