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

Not Applicable

Completed

• Conditions: Fasting Hypoglycemia; Diabetes Mellitus, Type 1
• Interventions: Drug: Glucagon Injection; Other: Glucose Tablets

• Registration Number: NCT03970772
• Lead Sponsor: Qassim University

Brief 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.

Study Timeline

• Study Start: 2019-04-15
• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-05-29
• Study First Posted: 2019-06-03
• Primary Completion: 2019-06-10
• Study Completion: 2019-08-15
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-09
• Last Update Posted: 2021-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Glucagon injection	Glucagon Injection	Dilute Glucagon (1 mg/ml)
Glucose tablets	Glucose Tablets	Dextrose glucose tablets

Primary Outcome Measures

Name	Time	Method
Changes in glucose values from baseline to 30 minute	30 minutes	The change in blood glucose from baseline to 30 minute following treatment of hypoglycemic events

Secondary Outcome Measures

Name	Time	Method
Events approached 100 mg/dL or increased by 30 mg/dL	60 Minutes	During the first hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will record the events approached 100 mg/dL or increased by 30 mg/dL
Maximum Glucose, during hypoglycemia event by CGM	120 Minutes	During the first two hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will record the maximum glucose value from CGM data.
The proportion of completion of fasts	2 Weeks	The proportion of completion of fasts following treatment of hypoglycemic events
Treatment success from first dose	60 Minutes	During the first hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will record the events with blood glucose concentration ≥50 mg/dl 15 minute AND ≥70 mg/dl 30 minute after the initial treatment of a hypoglycemic event
Mean Glucose Value, during hypoglycemia event by CGM	120 Minutes	During the first two hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will calculate the mean glucose value from CGM data
Time in Range, during hypoglycemia event by CGM	120 Minutes	During the first two hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will calculate the percentage of time in range 70-180 mg/dL from CGM data
Time spend below 70 mg/dL, during hypoglycemia event by CGM	120 Minutes	During the first two hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will calculate the percentage of time \<70 mg/dL from CGM data
Minimum Glucose, during hypoglycemia event by CGM	120 Minutes	During the first two hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will record the minimum glucose value from CGM data.
Mean Glucose Value, by CGM	2 Weeks	During the entire two weeks of intervention/comparator period, the investigators will calculate the mean glucose value from CGM data
Time in Range, by CGM	2 Weeks	During the entire two weeks of intervention/comparator period, the investigators will calculate the percentage of time in range 70-180 mg/dL from CGM data
Time spend below 70 mg/dL, by CGM	2 Weeks	During the entire two weeks of intervention/comparator period, the investigators will calculate the percentage of time \<70 mg/dL from CGM data
Time spend above 180 mg/dL, by CGM	2 Weeks	During the entire two weeks of intervention/comparator period, the investigators will calculate the percentage of time \>180 mg/dL from CGM data
Time spend above 250 mg/dL, by CGM	2 Weeks	During the entire two weeks of intervention/comparator period, the investigators will calculate the percentage of time \>250 mg/dL from CGM data
Coefficient of Variation, by CGM	2 Weeks	During the entire two weeks of intervention/comparator period, the investigators will calculate the Coefficient of Variation from CGM data

Trial Locations

Locations (1)

Qassim University; 🇸🇦 Buraydah, Saudi Arabia