Type1 Diabetes MellitusLSHBA1CNCT03864991
Lifestyle Changes and Glycemic Control in T1D
A study testing e-device for step count (fit-bit), e-messages for log book and e-messages for log book & fit-bit in people with Type1 Diabetes Mellitus and Life Style, run by Aga Khan University at 1 site in Pakistan.
Trial 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)… Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type1 Diabetes Mellitus, Life Style, Behavioral Changes
- What is being tested?
- e-device for step count (fit-bit), e-messages for log book and e-messages for log book & fit-bit
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Oct 2018to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University Hospital
Karachi, Sindh
Rehana Siddiqui, PhD, +922134864818 ext. 4818, rehana.siddiqui@aku.edu
Sobiya Sawani, MSc, +922134864954 ext. 4954, sobiya.sawani@aku.edu
About this study
Official title: Lifestyle Changes and Glycemic Control in Type 1 Diabetes Mellitus: A Factorial Design Approach
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.
Read the detailed description
Type 1 diabetes (T1D) occurs due to destruction of insulin producing beta cells in pancreas. T1D usually occurs in children and young individuals, and requires continuous blood glucose monitoring for adjustment of insulin dosage on a daily basis. Incidence of T1D has been increasing over the past three decades. Hyperglycemia and ketoacidosis episodes are common adverse effects due to irregular monitoring of daily blood glucose. It is a big challenge in developed as well as developing countries to live with T1D due to less optimal use of timely entry in logbook for self-monitoring of blood glucose (SMBG). Current guidelines recommend SMBG use in all patients with diabetes. According to a study, increased daily frequency of SMBG was significantly associated with lower glycated hemoglobin (HbA1C) along with added benefits of fewer acute complications among children and adolescents. Available literature from Pakistan highlights non-adherence of T1D patients to recommended dietary advice (58.5%), physical activity (42.3%) and prescribed insulin regimen (88.1%). Use of mobile applications has been shown to increase the medication adherence and use of self-blood glucose testing. Increased daily step count by T1D patients helped to reduce the risk of cardiovascular events. A wearable e-device accompanied with an application (Fitbit App) tracks step count by recording data in mobile application. HbA1C levels acts as an indicator for the glycemic control and correlates with complications. However, HbA1C cannot determine the daily variability of blood glucose, thus SMBG can help predict the average daily risk reduction in T1D complications. The proposed study will address the adherence to standard protocols for maintaining home based records by patients and caregivers and insulin therapy, optimizing the quarterly HbA1C levels.
- Being tested
- e-device for step count (fit-bit), e-messages for log book, e-messages for log book & fit-bit
- Keywords
- Log book, Step count, Diet, Physical activity, HbA1c, Blood sugar
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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-messages for log bookBehavioural
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 & fit-bitBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: e-device for step count (fit-bit); Behavioral: e-messages for log book & fit-bit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Each participant will be in the study for the period of six months
Secondary outcomes (1)
Episodes of acute complications
Hyperglycemia >450 mg/dl or "Hi" on glucometer, Ketoacidosis per hospital diagnosed, Hypoglycemia <60 mg/dl or "low" on glucometer three times a day.
Measured: Each participant will be in the study for the period of six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start29 Oct 2018
- Primary completion30 Nov 2019 (estimated)
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Iqbal Azam, Aga Khan University
- Investigators
- Iqbal Azam, MSc, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864991
- Sponsor's protocol ID
- 5363-CHS-ERC-18
- Acronym
- LSHBA1C
- Status last verified
- Mar 2019
- First submitted
- 28 Feb 2019
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32312302
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Changes and Glycemic Control in Type 1 Diabetes Mellitus: A Factorial Design Approach
- ClinicalTrials.gov ID
- NCT03864991
- Acronym / sponsor ID
- LSHBA1C / 5363-CHS-ERC-18
- Keywords
- Log book, Step count, Diet, Physical activity, HbA1c, Blood sugar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Type 1 diabetes (T1D) occurs due to destruction of insulin producing beta cells in pancreas. T1D usually occurs in children and young individuals, and requires continuous blood glucose monitoring for adjustment of insulin dosage on a daily basis. Incidence of T1D has been increasing over the past three decades. Hyperglycemia and ketoacidosis episodes are common adverse effects due to irregular monitoring of daily blood glucose. It is a big challenge in developed as well as developing countries to live with T1D due to less optimal use of timely entry in logbook for self-monitoring of blood glucose (SMBG). Current guidelines recommend SMBG use in all patients with diabetes. According to a study, increased daily frequency of SMBG was significantly associated with lower glycated hemoglobin (HbA1C) along with added benefits of fewer acute complications among children and adolescents. Available literature from Pakistan highlights non-adherence of T1D patients to recommended dietary advice (58.5%), physical activity (42.3%) and prescribed insulin regimen (88.1%). Use of mobile applications has been shown to increase the medication adherence and use of self-blood glucose testing. Increased daily step count by T1D patients helped to reduce the risk of cardiovascular events. A wearable e-device accompanied with an application (Fitbit App) tracks step count by recording data in mobile application. HbA1C levels acts as an indicator for the glycemic control and correlates with complications. However, HbA1C cannot determine the daily variability of blood glucose, thus SMBG can help predict the average daily risk reduction in T1D complications. The proposed study will address the adherence to standard protocols for maintaining home based records by patients and caregivers and insulin therapy, optimizing the quarterly HbA1C levels.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: e-device for step count (fit-bit)This group will receive e-device for step count (fit-bit) in addition to routine care. |
| e-messages for log book | Active comparator | Behavioral: e-messages for log bookThis group will receive daily e-messages for maintaining log book in addition to routine care. |
| e-messages for log book & fit-bit | Active comparator | Device: e-device for step count (fit-bit), Behavioral: e-messages for log book & fit-bitThis 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-device for step count (fit-bit)Patients in this group will receive fitbit device to count their daily steps and record it into their log books. | Device | e-device for step count (fit-bit), e-messages for log book & fit-bit |
| e-messages for log bookPatients 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. | Behavioural | e-messages for log book |
| e-messages for log book & fit-bitPatient 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. | Behavioural | e-messages for log book & fit-bit |
Primary outcome
Changes in HbA1c
Time frame: Each participant will be in the study for the period of six months
Blood HbA1c levels will be measured at baseline, three and six months. It will be taken on ratio scale measured in mmol/mol
1 secondary outcome
Episodes of acute complications
Time frame: Each participant will be in the study for the period of six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Derived from this study: PubMed 32312302Sawani 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iqbal Azam, MSc principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-device for step count (fit-bit), e-messages for log book and e-messages for log book & fit-bit in people with Type1 Diabetes Mellitus and Life Style, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amna R Siddiqui, Phd (00922134864818 ext. 4818, rehana.siddiqui@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in HbA1c (time frame: Each participant will be in the study for the period of six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03864991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.