N/A
N=2,062
Diabetes Prevention Using SMS Technology
Prediabetes
Bottom Line
View on ClinicalTrials.gov: NCT01795833 ↗Enrolled (actual)
2,062
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Number of Participants With Progression to Type 2 Diabetes — 216; 234 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Short text messages (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Progression to Type 2 Diabetes |
216; 234 | — |
| SECONDARY Body Weight |
79; 79.7; 77.4; 78.1 | — |
| SECONDARY Blood Pressure |
128.8; 129.3; 81; 81.5; 124.7; 124.8 | — |
| SECONDARY HDL Cholesterol |
1.2; 1.2; 1.2; 1.2 | — |
| SECONDARY LDL Cholesterol |
3.1; 3.0; 3.1; 3.1 | — |
| SECONDARY Triglycerides |
1.3; 1.3; 1.3; 1.3 | — |
| SECONDARY Total Physical Activity |
409; 412.2; 396.5; 400.9 | — |
Summary
Type 2 diabetes is a major healthcare problem in the developed and developing world. Recent clinical trials have demonstrated that it may be prevented by lifestyle intervention focused on diet and physical activity. These trials have been expensive and labour intensive and this has limited translation of the known benefits to the population at large.
We propose using a mobile phone intervention for lifestyle change and will assess it in a clinical trial(study) in people with impaired glucose regulation (high risk at developing type 2 diabetes).
The study will be conducted in both India and the UK. The purpose of the study is to assess the effectiveness and acceptability of a text messaging system to prevent the progression to diabetes in people with high risk. The study involves five visits to clinic over 2 year period.
Study participants will be divided into two groups by the computer generated random method - one is 'Usual Care' group and the other 'Text Messaging' group.
* Usual care will consist of a 30 minute interview, delivering personalized diet and exercise advice, supplemented by written material and education regarding diabetes. This will be delivered once at the beginning of the study.
* The intervention group will undergo the same initial interview and, in addition, will receive 3 times weekly text messaging with education, advice, support and motivation. These messages will be personalized to individual targets set at the initial interview.
The primary outcome will be progression to diabetes, with and without SMS intervention. Secondary outcomes will be improvements in physical activity (reported and directly measured), body weight and other cardiovascular risk factors (blood pressure, total and HDL cholesterol and serum triglycerides).
Eligibility Criteria
Inclusion Criteria
- Adults 18 yrs or over and less than 75 yrs
- HbA1c between 6.0-6.4%
Exclusion Criteria
- Pregnant or planning pregnancy
- Breastfeeding
- Enrolled in other clinical trials
- Have active malignancy or under investigation for malignancy
- Are unable to follow the protocol for any other reason
Data sourced from ClinicalTrials.gov (NCT01795833). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.