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

Study Overview
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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.

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

Conditions
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Type 1 Diabetes

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DM type 1 Age ≥14 years Patients on insulin pump (more than 3 months) Patients on MDI (glargine or detemir combined with aspart or lispro) regimen Diagnosis of type 1 DM of more than 6 months. Willing to do Self Monitoring Blood Sugar (SMBG) Have no other contraindication to fast Exclusion Criteria: Patient with renal or hepatic impairment Patient with diagnosed adrenal insufficiency Pregnancy Alcoholism Any diagnosed psychiatric disease Can not do SMBG

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Insulin pump<br> | |
| MDI<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Glycemic control | To assess the glycemic control in the two groups using HbA1c and Fructosamine assays. | Two (2) months | 
| overnight hypoglycemia | To estimate the rates of overnight hyperglycemia in both groups. | 5 weeks | 
| Rate of acute complications | To estimate presence of severe hyperglycemia and /or DKA episodes in both groups | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ramadan, Fasting, Diabetes, Type1, Insulin, Pump