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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01941238

Enrollment

142

Registered

2013-09-13

Start date

2013-07-31

Completion date

2014-11-30

Last updated

2015-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

Ramadan, Fasting, Diabetes, Type1, Insulin, Pump

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

14 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
overnight hypoglycemia	5 weeks	To estimate the rates of overnight hyperglycemia in both groups.
Rate of acute complications	5 weeks	To estimate presence of severe hyperglycemia and /or DKA episodes in both groups

Countries

Saudi Arabia

Outcome results