Overview

Mini-Dose Glucagon to Treat Fasting-induced Hypoglycemia During Ramadan

Status:
Completed
Trial end date:
2019-08-15
Target enrollment:
0
Participant gender:
All
Summary
This study aimed to develop a new approach for the treatment of fasting induced hypoglycemia during ramadan using mini-dose glucagon.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Qassim University
Treatments:
Glucagon
Glucagon-Like Peptide 1
Criteria
Inclusion Criteria:

1. Clinical diagnosis of T1DM using daily insulin

2. 18.0 to < 65.0 years of age with body mass index 20.0 to <35.0 kg/m2.

3. Having diabetes for ≥2.0 years

4. HbA1c <8.5%

5. Has a smart phone with access to the internet and welling to upload data during the
study period.

6. Welling to wear a devise such as continuous glucose monitor ≥6 days/week.

7. Females, not currently known to be pregnant

8. In good general health as evaluated by investigator based on available clinical data

9. Willing to comply to the protocol requirements for the duration of the study

Exclusion Criteria:

1. Any history of more than one severe hypoglycemic episode (need assistance by third
party) in the past 12 months

2. Any history of more than one episode of diabetic ketoacidosis in the past 12 months

3. Female pregnant or planning to get pregnant.

4. Use of any of the following medications: oral hypoglycemic agents, systemic
corticosteroids or beta-blocker, theophylline, beta-adrenergic agonists, 1st
generation anticholinergic drugs.

5. History of hypersensitivity to glucagon or severe hypersensitivity reactions (such as
angioedema) to any other medications

6. History of uncontrolled hypertension (systolic BP >160 mmHg or diastolic BP >100 mmHg)

7. History of seizure disorder.

8. Presence of any of conditions based on judgment of the investigator that could affect
or interfere with the response, absorption, metabolism or execration of glucagon.

9. Currently following any kind of weight-loss diet

10. Currently participation in another clinical trials