Mini-Dose Glucagon to Treat Fasting-induced Hypoglycemia During Ramadan
Condition: Fasting Hypoglycemia; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Hypoglycemia; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This study aimed to develop a new approach for the treatment of fasting induced hypoglycemia
      during ramadan using mini-dose glucagon.
    

Detailed description: 
      This study aimed to understand whether subcutaneously-given mini-dose glucagon (MDG) as an
      alternative to carbohydrate consumption could avert hypoglycemia or treat it effectively in
      type 1 diabetes patients who choose to fast during Ramadan in observance of their faith. This
      treatment method could also avert any negative psychological emotions Muslim people with
      diabetes may experience by ingesting carbohydrates to control hypoglycemia, thereby breaking
      their fast. Furthermore, it could improve ability to self-manage fasting, which is an
      important action for their spiritual and overall wellbeing.

      There will be two phases included in this study:

        1. Pre-crossover Phase:

           Before starting the crossover trial, a pre-crossover phase will conduct to evaluate
           hypoglycemia eligibility, frequency and compliance.

        2. Crossover Trial Phase:

      The Crossover Trial Phase will include 20 participants and consist of two (2-weeks) periods.
      Participants who don't develop any hypoglycemic event or failed to complete both periods will
      be excluded.

      Participants will be randomized into two groups:

        1. Group A in periods one will use MDG and glucose tablets in period two according to the
           protocol.

        2. Group B in periods one will use glucose tablets and MDG in period two according to the
           protocol.

      The primary outcome will be the number of treated fasting induced hypoglycemic events.
    

Intervention name(s): Glucagon Injection; Glucose Tablets
Intervention type(s): Drug; Other
Intervention description(s): Participants will be instructed to check their blood glucose (BG) with study meter once they developed hypoglycemia symptoms, their CGM reads below 70 mg/dl, or when the CGM glucose was trending down and the participant intended to treat to prevent hypoglycemia. Participants will be instructed to check BG with meter 3 times and treat the hypoglycemia event using mini-dose glucagon when their BG in range 40-69 mg/dl according a prescribed protocol.; Participants will be instructed to check their blood glucose (BG) with study meter once they developed hypoglycemia symptoms, their CGM reads below 70 mg/dl, or when the CGM glucose was trending down and the participant intended to treat to prevent hypoglycemia. Participants will be instructed to check BG with meter 3 times and treat the hypoglycemia event using glucose tablets when their BG in range 40-69 mg/dl according a prescribed protocol.
Intervention MeSH terms: Glucagon
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a Randomize Crossover study with a pre-crossover phase and a crossover trial phase, which will include a minimum of 20 participants and consist of two (2-weeks) periods.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 diabetes mellitus; Fasting; Ramadan; Glucagon; Mini-dose; Hypoglycemia