A novel approach to improving health outcomes among young adults with type 1 diabetes

Improving outcomes among young adults with type 1 diabetes: The D1 Now pilot RCT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN74114336

Enrollment

100

Registered

2019-11-12

Start date

2019-08-19

Completion date

Unknown

Last updated

2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Nutritional, Metabolic, Endocrine Type 1 diabetes mellitus

Interventions

The D1 Now intervention comprises three components: 1. Interactive Messaging System-Florence Florence or “Flo” is a SMS texting system that presents an easy-to-use, fri

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Physician confirmed diagnosis of T1D for more than 12 months. 2. Age between 18-25 years on the date of recruitment. 3. Access to a mobile phone device.

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
1. Recruitment of diabetes centres is measured using documentation of the number of invitations sent, the number of refusals and number of acceptances at beginning of the trial. 2. Recruitment of patients is measured using documentation of the number of invitations sent, the number of initial responses, the number of follow-up phone-calls required, the number of refusals and the number of acceptances at the beginning of the trial. 3. Attrition is measured using the number of participants who consent to participate and who remain in the study until the end of follow up at 12 months. 4. Missing data in returned questionnaires is measured at month 0 and month 12. 5. The comprehensibility and acceptability of all questionnaires is measured by asking participants; how the questionnaires might be improved, and how long they took to complete at month 0 and month 12.	—

Measure

Time frame

1. Recruitment of diabetes centres is measured using documentation of the number of invitations sent, the number of refusals and number of acceptances at beginning of the trial. 2. Recruitment of patients is measured using documentation of the number of invitations sent, the number of initial responses, the number of follow-up phone-calls required, the number of refusals and the number of acceptances at the beginning of the trial. 3. Attrition is measured using the number of participants who consent to participate and who remain in the study until the end of follow up at 12 months. 4. Missing data in returned questionnaires is measured at month 0 and month 12. 5. The comprehensibility and acceptability of all questionnaires is measured by asking participants; how the questionnaires might be improved, and how long they took to complete at month 0 and month 12.

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Secondary

Measure	Time frame
1. Glycated Haemoglobin (HbA1c) is measured using laboratory HbA1C at month 0 and month 12. 2. Diabetes Related Distress is measured using the Problem Areas in Diabetes-11 (PAID-11) at month 0 and month 12. 3. Diabetes Related Quality of Life is measured using the Audit of Diabetes Dependent Quality of life (ADDQOL) at month 0 and month 12. 4. Self-Management is measured using Diabetes Self-Management Questionnaire (DSMQ) at month 0 and month 12. 5. Level of Clinic Engagement is measured using clinic attendance and will be obtained from the clinic administration system at month 0 and month 12. 6. Perceived Level of Control is measured using the Diabetes Empowerment Scale – Short Form (DES-SF) at month 0 and month 12. 7. Number of Instances of Diabetes Ketoacidosis is measured using the definition ‘an episode of hyperglycaemia, ketoacidosis and ketonuria requiring hospital admission and care’ and this will be obtained from both the medical notes and through self-report at month 0 and 12. 8. Number of Instances of Severe Hypoglycaemia is measured using the definition ‘an episode of hypoglycaemia that requires assistance from another person to treat’ and this will be obtained through self-report at month 0 and 12. 9. Cost-effectiveness is measured using a bespoke questionnaire developed by the D1 Now study team and the EQ-5D-5L at month 0 and month 12.	—

Measure

Time frame

1. Glycated Haemoglobin (HbA1c) is measured using laboratory HbA1C at month 0 and month 12. 2. Diabetes Related Distress is measured using the Problem Areas in Diabetes-11 (PAID-11) at month 0 and month 12. 3. Diabetes Related Quality of Life is measured using the Audit of Diabetes Dependent Quality of life (ADDQOL) at month 0 and month 12. 4. Self-Management is measured using Diabetes Self-Management Questionnaire (DSMQ) at month 0 and month 12. 5. Level of Clinic Engagement is measured using clinic attendance and will be obtained from the clinic administration system at month 0 and month 12. 6. Perceived Level of Control is measured using the Diabetes Empowerment Scale – Short Form (DES-SF) at month 0 and month 12. 7. Number of Instances of Diabetes Ketoacidosis is measured using the definition ‘an episode of hyperglycaemia, ketoacidosis and ketonuria requiring hospital admission and care’ and this will be obtained from both the medical notes and through self-report at month 0 and 12. 8. Number of Instances of Severe Hypoglycaemia is measured using the definition ‘an episode of hypoglycaemia that requires assistance from another person to treat’ and this will be obtained through self-report at month 0 and 12. 9. Cost-effectiveness is measured using a bespoke questionnaire developed by the D1 Now study team and the EQ-5D-5L at month 0 and month 12.

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Countries

Ireland, Northern Ireland, United Kingdom

Contacts

Public ContactEimear Morrissey

eimear.morrissey@nuigalway.ie+353 91495954

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 19, 2026