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

Reem Mohammad Alamoudi

Status: Completed

Conditions: Type 1 Diabetes

Study type: Observational

Funder types: Other

Identifiers

NCT01941238

RE12-002

Details and patient eligibility

About

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.

Enrollment: 142 patients

Sex: All

Ages: 14 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

142 participants in 2 patient groups

Insulin pump

MDI