NCT04383990

Brief Summary

To compare different timing of insulin Glargine administration (early-6 pm versus standard bedtime-10 pm) as part of standard of care in patients with type1 diabetes who wish to fast the month of Ramadan.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

April 28, 2021

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

April 14, 2020

Last Update Submit

April 27, 2021

Conditions

Type1diabetesFastingInsulin

Keywords

Type1 DiabetesFastingInsulin GlargineRamadanHypoglycemia

Outcome Measures

Primary Outcomes (1)

  • Hypoglycemia incidence

    To determine if taking basal insulin Glargine at 6 pm is associated with less rates of hypoglycemia -(we will consider glucose level of 70 mg/dl ( 3.9 mmol/l) and below as the level of hypoglycemia ) - compared to bedtime timing (10-12pm) during fasting Ramadan in patients with T1DM.

    Through study completion, an average of 3 months

Secondary Outcomes (5)

  • Glucose variability

    Through study completion, an average of 3 months

  • Days fast broken

    Through study completion, an average of 3 months

  • Glycemic control

    Through study completion, an average of 3 months

  • Hyperglycemia

    Through study completion, an average of 3 months

  • Acute diabetes complications

    Through study completion, an average of 3 months

Study Arms (2)

Early Glargine

ACTIVE COMPARATOR

To take insulin Glargine at 6-7 pm

Other: Timing of taking insulin

Late Glargine

ACTIVE COMPARATOR

To take insulin Glargine at 10-12 pm

Other: Timing of taking insulin

Interventions

Timing of taking insulinOTHER

To take insulin Glargine early (6-7pm) or late (bedtime-10-12pm)

Early GlargineLate Glargine

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • DM type 1
  • Age \> 14 years
  • Diagnosis of type 1 DM of more than 6 months.
  • Committed to do SMBG

You may not qualify if:

  • Renal and hepatic impairment
  • Adrenal insufficiency
  • Pregnancy
  • Alcohol consumption
  • Any diagnosed psychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KingAbullahIMRC

Jeddah, Saudi Arabia

Location

MeSH Terms

Conditions

FastingInsulin ResistanceHypoglycemia

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Open label Randomized
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2020

First Posted

May 12, 2020

Study Start

February 28, 2020

Primary Completion

August 31, 2020

Study Completion

November 30, 2020

Last Updated

April 28, 2021

Record last verified: 2020-05

Locations

SA(1)