Management of Type-2 Diabetic Patients Treated With Insulin During the Ramadan

Fasting during the Ramadan is one of the five pillars of Islam and is a mandatory duty for all healthy adult Muslims. Fasting is considered safe in young healthy subjects but it can induce harmful effects and complications in patients with diabetes. Several studies have demonstrated that patients with type 2 diabetes are prone to hypo and hyper glycemia during fasting. When treating diabetic patients with a treatment guideline the rate of these complications can be reduced. Little data is available on patients with type 2 diabetes treated with insulin. The investigators therefore propose to assess the effect of a protocol containing detemir (levemir) and a premix of insulin aspart (NovoMix70) on glucose control in patients with type 2 diabetes during the Ramadan and to compare this regimen to the standard care patients receive during this period. The investigators assume that patients receiving the intervention will have better glucose control during the Ramadan compared to patients receiving the standard care. As approximately 45 million Muslims suffer from type 2 diabetes and most of them fast during the Ramadan the results of this intervention may be significant and may improve the care of these patients allowing Muslims to respect their religious obligations without compromising their health.

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Key information

Conditions

Diabetes Type 2 Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Fasting Feeding Behavior Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Treatment During Ramadan

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clalit HMO

Haifa, Israel

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

All of these criteria should be present.

Patients with a diagnosis of type 2 diabetes treated with insulin (premix preparations or basal and rapid acting insulin) with or without metformin and/or a sulfonylurea drug for at least three months
HbA1c in the past three months ≤ 10%
Being capable, and willing, to perform self blood glucose monitoring and use a patient diary as required
Age > 18 years

Exclusion criteria

Any of the following:

Patients with a diagnosis of type 1 diabetes
Hypoglycemia unawareness
Hypersensitivity to levemir
Hypersensitivity to NovoMix70
Creatinine > 2.5 mg/l
AST and or ALT > 1.5 times the upper limit
Pregnancy
Mental incapacity, unwillingness or language barrier precluding adequate understanding of the study protocol or cooperation

Treatment and study plan

Insulin treatment during Ramadan

Drug

Insulin analogs will be used: Levemir and NovoMix70. The daily insulin dose will be calculated as follows: Sixty percent of the total daily dose will be used as the beginning daily dose at the first day of fasting. Sixty percent of the daily dose will be given as NovoMix70 before the Eftar (the main meal in the evening that breaks the fast). Forty percent of the amount will be given as Levemir (Early in the morning before the beginning of fasting.

Standard of care

Drug

Standard of care during Ramadan according to physicians decision

Primary outcomes

Difference in mean 4-point SMBG during days 23-30 of treatment between the two groups.

Time frame: days 23-30 of treatment

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Official study title

Management of Type-2 Diabetic Patients Treated With Insulin During the Ramadan An Interventional, Community Based, Comparative Study

Acronym: DMR

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: May 17, 2011
Registry last updated: Apr 12, 2013

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.

Published trials that share one or more normalized conditions with this study.

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