Lifestyle Changes and Glycemic Control in T1D

NCT03864991 | Unknown

• 1 other identifier: 5363-CHS-ERC-18
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Pakistani studies report non-adherence to self-management by type 1 diabetes (T1D) patients, and episodes of hypoglycemia and ketoacidosis as acute complications. Self-management guidelines include maintenance of logbooks for blood glucose, physical activity, and dietary intake, that affect glycated hemoglobin (HbA1C) and acute complications. The proposed study will evaluate whether mobile messaging for maintaining log books for blood glucose or e-device use for step count will modify HbA1c levels to be examined at three and six months after enrollment. In addition, episodes of acute complications and blood glucose variability will be correlated with daily log book maintenance and step counts.

Conditions

Type1 Diabetes Mellitus; Life Style; Behavioral Changes; Self-Management

Keywords

Log book; Step count; Diet; Physical activity; HbA1c; Blood sugar

Outcome Measures

Primary Outcomes (1)

• Changes in HbA1c

  Blood HbA1c levels will be measured at baseline, three and six months. It will be taken on ratio scale measured in mmol/mol

  Each participant will be in the study for the period of six months

Secondary Outcomes (1)

• Episodes of acute complications

  Each participant will be in the study for the period of six months

Study Arms (4)

Routine Care

NO INTERVENTION

This group will be followed up for routine care, maintaining a standard log book for documenting blood sugar and insulin dosages per advice and explanation by doctors, nurses and nutritionists.

e-device for step count (fit-bit)

ACTIVE COMPARATOR

This group will receive e-device for step count (fit-bit) in addition to routine care.

Device: e-device for step count (fit-bit)

e-messages for log book

ACTIVE COMPARATOR

This group will receive daily e-messages for maintaining log book in addition to routine care.

Behavioral: e-messages for log book

e-messages for log book & fit-bit

ACTIVE COMPARATOR

This group will receive e-device for step count (fit-bit), daily e-messages for maintaining log book for blood sugar, insulin dosages and step count in addition to routine care.

Device: e-device for step count (fit-bit); Behavioral: e-messages for log book & fit-bit

Interventions

e-device for step count (fit-bit) DEVICE

Patients in this group will receive fitbit device to count their daily steps and record it into their log books.

e-device for step count (fit-bit); e-messages for log book & fit-bit

e-messages for log book BEHAVIORAL

Patients in this group will receive e-messages to maintain their log books as per instruction for blood sugar levels and send back weekly through snap shot.

e-messages for log book

e-messages for log book & fit-bit BEHAVIORAL

Patient in this group will receive e-messages to maintain their log books for blood sugar levels as well as use fitbit device and maintain their log book for daily step count and send back weekly through snap shot.

e-messages for log book & fit-bit

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient diagnosed with T1D \> 6 months
• Patient's age ≥ 15 years
• Patient or any one of the family member like father, mother or sibling using smart phone.
• Patient or any one of the family member know how to use (receive calls or read text message) a smart phone.

You may not qualify if:

• Patient on insulin pump
• Pregnant females,
• Patient with neurodevelopmental delay or thalassemia
• Patient currently using any kind of authentic e-device for step count or physical activity.

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, Pakistan

RECRUITING

Related Publications (1)

• Sawani S, Siddiqui AR, Azam SI, Humayun K, Ahmed A, Habib A, Naz S, Tufail M, Iqbal R. Lifestyle changes and glycemic control in type 1 diabetes mellitus: a trial protocol with factorial design approach. Trials. 2020 Apr 20;21(1):346. doi: 10.1186/s13063-020-4205-7.

  PMID: 32312302 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Iqbal Azam, MSc

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amna R Siddiqui, Phd

CONTACT

00922134864818; rehana.siddiqui@aku.edu

Sobiya Q Sawani, MSc

CONTACT

00922134864954; sobiya.sawani@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A factorial design approach will be taken to study the lifestyle change for self-management of T1D. A randomized controlled method will enroll patients in four groups. All groups will be working with a standard log book for documenting blood sugar and routine care as advise by doctors, nurses, and nutritionists. First group will be entirely of routine care follow up, second group will receive additional e-device for step count (fitbit), third group will receive routine care and e-messages as reminders to maintain a daily log book, and fourth group will be receiving e-device for step count (fitbit) and e-messages for maintain blood glucose and step count log book in addition to routine care. All four groups will be followed up for a period of six months. Log book data will be obtained at a monthly interval and HbA1c as a main outcome will be measured three times, at baseline, at three and six months.

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 6, 2019
• Study Start: October 29, 2018
• Primary Completion: November 30, 2019
• Study Completion: May 31, 2020
• Last Updated: March 6, 2019

Record last verified: 2019-03

Locations

PA (1)