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OpenTrials
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NCT Number: NCT01941238

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Behavior Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Fasting Feeding Behavior Glucose Metabolism Disorders Hyperinsulinism Immune System Diseases Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

14 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Guards Hospital

Dammam, 31412, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of hypoglycemia

    Time frame: 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 outcomes

  1. Number of fasting days lost

    Time frame: 5 weeks

    To estimate the number of days they needed to brake their fast due to acute complications (hypoglycemia, severe hyperglycemia, or DKA).

  2. Glycemic control

    Time frame: Two (2) months

    To assess the glycemic control in the two groups using HbA1c and Fructosamine assays.

  3. overnight hypoglycemia

    Time frame: 5 weeks

    To estimate the rates of overnight hyperglycemia in both groups.

  4. Rate of acute complications

    Time frame: 5 weeks

    To estimate presence of severe hyperglycemia and /or DKA episodes in both groups

Sponsors and collaborators

Lead sponsor

Reem Mohammad Alamoudi

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Sep 13, 2013
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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